search
Back to results

Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Primary Purpose

Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Taperloc Complete Microplasty stem
Taperloc Complete Reduced Distal stem
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Total Hip Arthroplasty, Medical Device, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
  • Correction of functional deformity.

  • Male or female

    -≥ 18 and ≤ 70 years of age

  • Subjects willing to return for follow-up evaluations.
  • Subjects able to read and understand Dutch language.

Exclusion Criteria:

  • active Infection (or within 6 weeks after infection)
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • diagnosed Osteoporosis or Osteomalacia
  • Metabolic disorders which may impair bone formation
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy or neuromuscular disease.

Sites / Locations

  • Bravis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Taperloc Complete Microplasty stem

Taperloc Complete Reduced Distal stem

Arm Description

Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.

Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.

Outcomes

Primary Outcome Measures

Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)

Secondary Outcome Measures

Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Early Survival Assessed by Counting the Number of Implant Revisions
Assessed by counting the number of implant revisions
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Clinical Performance Measured by Patient Based Outcome EQ5D
Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.

Full Information

First Posted
January 8, 2018
Last Updated
June 21, 2022
Sponsor
Zimmer Biomet
search

1. Study Identification

Unique Protocol Identification Number
NCT03409666
Brief Title
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Official Title
Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Detailed Description
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner. All potential study subjects will be required to participate in the Informed Consent process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Rheumatoid Arthritis
Keywords
Total Hip Arthroplasty, Medical Device, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 assignment of treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taperloc Complete Microplasty stem
Arm Type
Experimental
Arm Description
Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.
Arm Title
Taperloc Complete Reduced Distal stem
Arm Type
Active Comparator
Arm Description
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Intervention Type
Device
Intervention Name(s)
Taperloc Complete Microplasty stem
Other Intervention Name(s)
Total hip arthroplasty
Intervention Description
Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
Intervention Type
Device
Intervention Name(s)
Taperloc Complete Reduced Distal stem
Other Intervention Name(s)
Total hip arthroplasty
Intervention Description
Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
Primary Outcome Measure Information:
Title
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Description
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Time Frame
2 years postoperatively
Secondary Outcome Measure Information:
Title
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Description
Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Time Frame
2 years postoperatively
Title
Early Survival Assessed by Counting the Number of Implant Revisions
Description
Assessed by counting the number of implant revisions
Time Frame
Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Title
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Description
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Time Frame
pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Title
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Description
Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Time Frame
6 weeks, 1 year and 2 years postoperatively
Title
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Description
The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Time Frame
2 years postoperatively
Title
Clinical Performance Measured by Patient Based Outcome EQ5D
Description
Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Time Frame
2 years postoperatively
Title
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
Description
The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.
Time Frame
pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Title
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
Description
The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.
Time Frame
6 weeks, 1 year and 2 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. Correction of functional deformity. Male or female -≥ 18 and ≤ 70 years of age Subjects willing to return for follow-up evaluations. Subjects able to read and understand Dutch language. Exclusion Criteria: active Infection (or within 6 weeks after infection) Sepsis Osteomyelitis Uncooperative patient or patient with neurologic disorders who are incapable of following directions diagnosed Osteoporosis or Osteomalacia Metabolic disorders which may impair bone formation Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy or neuromuscular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Vivoda, BSc
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Bravis
City
Roosendaal
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

We'll reach out to this number within 24 hrs