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A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

Primary Purpose

Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
European Hip
Zweymüller
CLS Spotorno
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cementless

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime. ii) Age - The subject's age is between 18 and 75 years inclusive. iii) Sex - Male or female subjects may be recruited to the study. iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease. v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study. Exclusion Criteria: i) Subjects undergoing revision procedure to the operative hip. ii) Subjects who have had a previous femoral osteotomy to the operative hip. iii) Subjects who have a history of active sepsis in the joint. iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma). v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease. vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation. vii) Subject's whose weight is > 100kg. viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only). ix) Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only). x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only) xi) Subjects with a known history of poor compliance to medical treatment.

Sites / Locations

  • Univ. Kliniken
  • Univesitätsklinikum Jena
  • InstitutoAzienda Gaetano Pini

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

European Hip

Zweymüller

CLS Spotorno

Arm Description

A cementless femoral component for use in total hip replacement

A cementless femoral component for use in total hip replacement

A cementless femoral component for use in total hip replacement

Outcomes

Primary Outcome Measures

To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason.

Secondary Outcome Measures

Implant survivorship at 5 and 10 years.
This post market study was terminated early; therefore the 5 and 10 year data was not collected.
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Harris Hip Score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 and 10 year data was not collected
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
he Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post-market study was terminated early; therefore the 5 & 10 year data was not collected
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This study was terminated early; therefore the 5 & 10 year data was not collected
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position.
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Component moves away, continuously over time, from its immediate post-operative position
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
This post market study was terminated early; therefore the 5 & 10 year data was not collected
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
This post market study was terminated early; therefore the 5 & 10 year data was not collected
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
This post market study was terminated early; therefore the 5 & 10 year data was not collected

Full Information

First Posted
September 13, 2005
Last Updated
October 6, 2016
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208468
Brief Title
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
Official Title
A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.
Study Start Date
February 2000 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis, Perthes Disease
Keywords
Hip, Cementless

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
European Hip
Arm Type
Other
Arm Description
A cementless femoral component for use in total hip replacement
Arm Title
Zweymüller
Arm Type
Active Comparator
Arm Description
A cementless femoral component for use in total hip replacement
Arm Title
CLS Spotorno
Arm Type
Active Comparator
Arm Description
A cementless femoral component for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
European Hip
Intervention Description
A cementless femoral component for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Zweymüller
Intervention Description
A cementless femoral component for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
CLS Spotorno
Intervention Description
A cementless femoral component for use in total hip replacement
Primary Outcome Measure Information:
Title
To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
Description
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason.
Time Frame
2yrs post-surgery
Secondary Outcome Measure Information:
Title
Implant survivorship at 5 and 10 years.
Description
This post market study was terminated early; therefore the 5 and 10 year data was not collected.
Time Frame
5 & 10 year post-op
Title
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
Time Frame
3 Months post-op
Title
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
Time Frame
6 Months post-op
Title
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
Time Frame
12 months post-op
Title
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Harris Hip Score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
Time Frame
24 months post-op
Title
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 and 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
Time Frame
3 months post-op
Title
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
Time Frame
6 months post-op
Title
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
Time Frame
12 months post-op
Title
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
he Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
Time Frame
24 months post-op
Title
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5& 10 years post-op
Title
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
3 months post-op
Title
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
6 months post-op
Title
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
12 months post-op
Title
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
24 months post-op
Title
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
3 months post-op
Title
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
6 month post-op
Title
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
12 months post-op
Title
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Width of lucency increases over time or expands lengthwise (into neighboring zones).
Time Frame
24 months post-op
Title
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post-market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 year post-op
Title
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
3 months post-op
Title
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
6 months post-op
Title
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
12 months post-op
Title
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
24 months post-op
Title
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
3 months post-op
Title
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
6 months post-op
Title
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
12 months post-op
Title
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position
Time Frame
24 months post-op
Title
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
3 months post-op
Title
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position
Time Frame
6 months post-op
Title
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
12 months post-op
Title
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
24 months post-op
Title
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
3 months post-op
Title
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position.
Time Frame
6 months post-op
Title
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position
Time Frame
12 months post-op
Title
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Component moves away, continuously over time, from its immediate post-operative position
Time Frame
24 months post-op
Title
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Time Frame
3 months post-op
Title
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'
Time Frame
6 months post-op
Title
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Time Frame
12 months post-op
Title
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Trochanter portion of the bone does not heal correctly to proximal portion of the femoral shaft. Typically, after 6 months the lack of correct healing is classified as a 'non-union'.
Time Frame
24 months post-op
Title
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
Time Frame
3 months post-op
Title
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
Time Frame
6 months post-op
Title
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
Time Frame
12 months post-op
Title
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Alignment is classified into 1 of 3 categories - Neutral, Varus (distal tip of stem lateral to mid-line of femur), or Valgus (distal tip of stem medial to mid-line of femur).
Time Frame
24 months post-op
Title
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
Time Frame
3 months post-op
Title
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
Time Frame
6 months post-op
Title
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
Time Frame
12 months post-op
Title
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
Presented by Brooker in JBJS 55a: 1629-1632 (1973). Soft tissue or bone bridging causing immobilization in severe cases; categorized into classes I to IV with I being islands of bone around soft tissue, and IV representing ankylosis of the hip.
Time Frame
24 months post-op
Title
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op
Title
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Time Frame
3 months post-op
Title
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Time Frame
6 months post-op
Title
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket
Time Frame
12 months post-op
Title
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
Linear wear, measured in millimeters (mm) of the femoral head into the acetabular socket.
Time Frame
24 months post-op
Title
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices
Description
This post market study was terminated early; therefore the 5 & 10 year data was not collected
Time Frame
5 & 10 years post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime. ii) Age - The subject's age is between 18 and 75 years inclusive. iii) Sex - Male or female subjects may be recruited to the study. iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease. v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study. Exclusion Criteria: i) Subjects undergoing revision procedure to the operative hip. ii) Subjects who have had a previous femoral osteotomy to the operative hip. iii) Subjects who have a history of active sepsis in the joint. iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma). v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease. vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation. vii) Subject's whose weight is > 100kg. viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only). ix) Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only). x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only) xi) Subjects with a known history of poor compliance to medical treatment.
Facility Information:
Facility Name
Univ. Kliniken
City
Graz
Country
Austria
Facility Name
Univesitätsklinikum Jena
City
Eisenberg
Country
Germany
Facility Name
InstitutoAzienda Gaetano Pini
City
Milan
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

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