An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
Primary Purpose
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DePuy Proxima™ Hip
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthroplasty, Replacement, Hip, Conservative, Anatomic, Cementless
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects between 18 and 70 years of age.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.
- Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.
Exclusion Criteria:
- Subjects with active local or systemic infection
- Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- Subjects with Charcot's or Paget's disease.
- Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.
- Subjects with severe osteoporosis.
- Subjects with previous proximal femoral fractures.
- Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
- Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing
- Subjects who have previously undergone osteotomy or arthrodesis of the hip.
- Subjects undergoing a simultaneous bilateral hip operation.
- Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
- Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Sites / Locations
- Hospital Belle Isle
- Hospital de Santo Antonio
- Hospital Clinic Barcelona
- Pilgrim Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DePuy Proxima™ Hip
Arm Description
A short, anatomic, cementless femoral component for use in total hip arthroplasty
Outcomes
Primary Outcome Measures
Kaplan-Meier survivorship calculated at the five-year time-point
Secondary Outcome Measures
Annual Kaplan-Meier survivorship calculations
Harris Hip Score
Oxford Hip Score
UCLA Activity Score
Hip Outcome Score
EuroQol EQ-5D
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Annual Kaplan-Meier survivorship calculations
Harris Hip Score
Harris Hip Score
Harris Hip Score
Harris Hip Score
Harris Hip Score
Radiographic Analysis
Radiographic Analysis
Radiographic Analysis
Radiographic Analysis
Radiographic Analysis
Radiographic Analysis
Radiographic Analysis
Oxford Hip Score
Oxford Hip Score
UCLA Activity Score
UCLA Activity Score
Hip Outcome Score
Hip Outcome Score
EuroQol EQ-5D
EuroQol EQ-5D
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
UCLA Activity Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
Hip Outcome Score
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01134445
Brief Title
An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
Official Title
Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early for business reasons
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
January 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (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 DePuy PROXIMA™ hip 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, Conservative, Anatomic, Cementless
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DePuy Proxima™ Hip
Arm Type
Other
Arm Description
A short, anatomic, cementless femoral component for use in total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
DePuy Proxima™ Hip
Intervention Description
A short, anatomic, cementless femoral component for use in total hip arthroplasty
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculated at the five-year time-point
Time Frame
5yrs post surgery
Secondary Outcome Measure Information:
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
1yr post-surgery
Title
Harris Hip Score
Time Frame
6mths post-surgery
Title
Oxford Hip Score
Time Frame
3mths post-surgery
Title
UCLA Activity Score
Time Frame
3mths post-surgery
Title
Hip Outcome Score
Time Frame
3mths post-surgery
Title
EuroQol EQ-5D
Time Frame
3mths post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
2yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
3yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
4yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
6yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
7yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
8yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
9yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
10yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
11yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
12yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
13yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
14yrs post-surgery
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
15yrs post-surgery
Title
Harris Hip Score
Time Frame
1yr post-surgery
Title
Harris Hip Score
Time Frame
2yrs post-surgery
Title
Harris Hip Score
Time Frame
5yrs post-surgery
Title
Harris Hip Score
Time Frame
10yrs post-surgery
Title
Harris Hip Score
Time Frame
15yrs post-surgery
Title
Radiographic Analysis
Time Frame
3mths post-surgery
Title
Radiographic Analysis
Time Frame
6mths post-surgery
Title
Radiographic Analysis
Time Frame
1yr post-surgery
Title
Radiographic Analysis
Time Frame
2yrs post-surgery
Title
Radiographic Analysis
Time Frame
5yrs post-surgery
Title
Radiographic Analysis
Time Frame
10yrs post-surgery
Title
Radiographic Analysis
Time Frame
15 yrs post-surgery
Title
Oxford Hip Score
Time Frame
6mths post-surgery
Title
Oxford Hip Score
Time Frame
1yr post-sugery
Title
UCLA Activity Score
Time Frame
6mths post-surgery
Title
UCLA Activity Score
Time Frame
1yr post-surgery
Title
Hip Outcome Score
Time Frame
6mths post-surgery
Title
Hip Outcome Score
Time Frame
1yr post-surgery
Title
EuroQol EQ-5D
Time Frame
6mths post-surgery
Title
EuroQol EQ-5D
Time Frame
1yr post-surgery
Title
Oxford Hip Score
Time Frame
2yrs post-surgery
Title
Oxford Hip Score
Time Frame
3yrs post-surgery
Title
Oxford Hip Score
Time Frame
4yrs post-surgery
Title
Oxford Hip Score
Time Frame
5yrs post-surgery
Title
Oxford Hip Score
Time Frame
6yrs post-surgery
Title
Oxford Hip Score
Time Frame
7yrs post-surgery
Title
Oxford Hip Score
Time Frame
8yrs post-surgery
Title
Oxford Hip Score
Time Frame
9yrs post surgery
Title
Oxford Hip Score
Time Frame
10yrs post-surgery
Title
Oxford Hip Score
Time Frame
11yrs post-surgery
Title
Oxford Hip Score
Time Frame
12yrs post-surgery
Title
Oxford Hip Score
Time Frame
13yrs post-sugery
Title
Oxford Hip Score
Time Frame
14yrs post-surgery
Title
Oxford Hip Score
Time Frame
15yrs post-surgery
Title
UCLA Activity Score
Time Frame
2yrs post-surgery
Title
UCLA Activity Score
Time Frame
3yrs post-surgery
Title
UCLA Activity Score
Time Frame
4yrs post-surgery
Title
UCLA Activity Score
Time Frame
5yrs post-surgery
Title
UCLA Activity Score
Time Frame
6yrs post-surgery
Title
UCLA Activity Score
Time Frame
7yrs post-surgery
Title
UCLA Activity Score
Time Frame
8yrs post-surgery
Title
UCLA Activity Score
Time Frame
9yrs post-surgery
Title
UCLA Activity Score
Time Frame
10yrs post-surgery
Title
UCLA Activity Score
Time Frame
11yrs post-surgery
Title
UCLA Activity Score
Time Frame
12yrs post-surgery
Title
UCLA Activity Score
Time Frame
13yrs post-surgery
Title
UCLA Activity Score
Time Frame
14yrs post-surgery
Title
UCLA Activity Score
Time Frame
15yrs post-surgery
Title
Hip Outcome Score
Time Frame
2yrs post-surgery
Title
Hip Outcome Score
Time Frame
3yrs post-surgery
Title
Hip Outcome Score
Time Frame
4yrs post-surgery
Title
Hip Outcome Score
Time Frame
5yrs post-surgery
Title
Hip Outcome Score
Time Frame
6yrs post-surgery
Title
Hip Outcome Score
Time Frame
7yrs post-surgery
Title
Hip Outcome Score
Time Frame
8yrs post-surgery
Title
Hip Outcome Score
Time Frame
9yrs post-surgery
Title
Hip Outcome Score
Time Frame
10yrs post-surgery
Title
Hip Outcome Score
Time Frame
11yrs post-surgery
Title
Hip Outcome Score
Time Frame
12yrs post-surgery
Title
Hip Outcome Score
Time Frame
13yrs post-surgery
Title
Hip Outcome Score
Time Frame
14yrs post-surgery
Title
Hip Outcome Score
Time Frame
15yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
2yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
3yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
4yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
5yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
6yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
7yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
8yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
9yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
10yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
11yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
12yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
13yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
14yrs post-surgery
Title
EuroQol EQ-5D
Time Frame
15yrs post-surgery
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:
Male or female subjects between 18 and 70 years of age.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.
Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.
Exclusion Criteria:
Subjects with active local or systemic infection
Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
Subjects with Charcot's or Paget's disease.
Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.
Subjects with severe osteoporosis.
Subjects with previous proximal femoral fractures.
Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
Subjects who are currently involved in any injury litigation claims.
Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing
Subjects who have previously undergone osteotomy or arthrodesis of the hip.
Subjects undergoing a simultaneous bilateral hip operation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Facility Information:
Facility Name
Hospital Belle Isle
City
Metz
Country
France
Facility Name
Hospital de Santo Antonio
City
Porto
Country
Portugal
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Facility Name
Pilgrim Hospital
City
Boston
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
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