Back to resultsMulti-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
Primary Purpose
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Delta Motion
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthroplasty, Replacement, Hip, Cementless, Ceramic on Ceramic
Eligibility Criteria
Inclusion Criteria
i) Male or female subjects, aged between 18 and 70 years inclusive.
ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use
Exclusion Criteria
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.
ii) Women who are pregnant.
iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.
v) Subjects who are currently involved in any injury litigation claims.
Sites / Locations
- Apollo Speciality hospital, 320 Anna Salai
- All India Institute of Medical Sciences, Ansari nagar, South Extension
- Robert Jones and Agnes Hunt
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Delta Motion
Arm Description
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement
Outcomes
Primary Outcome Measures
Kaplan-Meier survivorship
To determine survivorship of the DeltaMotion Cup System at 3 years
Secondary Outcome Measures
Kaplan-Meier survivorship
To determine survivorship of the DeltaMotion Cup System at 10 years
Harris Hip Score
Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion.
Oxford Hip Score
Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery.
University of California Los Angeles (UCLA) Score
Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement
Western Ontario and McMaster Universities (WOMAC) Score
Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee
Radiological analysis
Acetabular Migration (vertical or horizontal) less than 5mm
Acetabular Migration (varus or valgus) less than 5 degrees
No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01635166
Brief Title
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
Official Title
A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (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
The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis, Traumatic Femoral Fractures, Congenital Hip Dysplasia
Keywords
Arthroplasty, Replacement, Hip, Cementless, Ceramic on Ceramic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delta Motion
Arm Type
Other
Arm Description
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Delta Motion
Intervention Description
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship
Description
To determine survivorship of the DeltaMotion Cup System at 3 years
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Kaplan-Meier survivorship
Description
To determine survivorship of the DeltaMotion Cup System at 10 years
Time Frame
10yrs post-surgery
Title
Harris Hip Score
Description
Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion.
Time Frame
10yrs post-surgery
Title
Oxford Hip Score
Description
Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery.
Time Frame
10yrs post-surgery
Title
University of California Los Angeles (UCLA) Score
Description
Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement
Time Frame
10yrs post-surgery
Title
Western Ontario and McMaster Universities (WOMAC) Score
Description
Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee
Time Frame
10yrs post-surgery
Title
Radiological analysis
Description
Acetabular Migration (vertical or horizontal) less than 5mm
Acetabular Migration (varus or valgus) less than 5 degrees
No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones.
Time Frame
10yrs post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
i) Male or female subjects, aged between 18 and 70 years inclusive.
ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use
Exclusion Criteria
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.
ii) Women who are pregnant.
iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.
v) Subjects who are currently involved in any injury litigation claims.
Facility Information:
Facility Name
Apollo Speciality hospital, 320 Anna Salai
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
All India Institute of Medical Sciences, Ansari nagar, South Extension
City
New Dehli
ZIP/Postal Code
110029
Country
India
Facility Name
Robert Jones and Agnes Hunt
City
Oswestry
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
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