Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, avascular necrosis, traumatic femoral fractures, congenital hip dysplasia
Treatment depuy proxima™ hip
Phase phase 4
Sponsor DePuy International
Start date February 2010
End date January 2016
Trial size 42 participants
Trial identifier NCT01134445, CT07/02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
A short, anatomic, cementless femoral component for use in total hip arthroplasty
depuy proxima™ hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty

Primary Outcomes

Measure
Kaplan-Meier survivorship calculated at the five-year time-point
time frame: 5yrs post surgery

Secondary Outcomes

Measure
Annual Kaplan-Meier survivorship calculations
time frame: 1yr post-surgery
Harris Hip Score
time frame: 6mths post-surgery
Oxford Hip Score
time frame: 3mths post-surgery
UCLA Activity Score
time frame: 3mths post-surgery
Hip Outcome Score
time frame: 3mths post-surgery
EuroQol EQ-5D
time frame: 3mths post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 2yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 3yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 4yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 6yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 7yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 8yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 9yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 10yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 11yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 12yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 13yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 14yrs post-surgery
Annual Kaplan-Meier survivorship calculations
time frame: 15yrs post-surgery
Harris Hip Score
time frame: 1yr post-surgery
Harris Hip Score
time frame: 2yrs post-surgery
Harris Hip Score
time frame: 5yrs post-surgery
Harris Hip Score
time frame: 10yrs post-surgery
Harris Hip Score
time frame: 15yrs post-surgery
Radiographic Analysis
time frame: 3mths post-surgery
Radiographic Analysis
time frame: 6mths post-surgery
Radiographic Analysis
time frame: 1yr post-surgery
Radiographic Analysis
time frame: 2yrs post-surgery
Radiographic Analysis
time frame: 5yrs post-surgery
Radiographic Analysis
time frame: 10yrs post-surgery
Radiographic Analysis
time frame: 15 yrs post-surgery
Oxford Hip Score
time frame: 6mths post-surgery
Oxford Hip Score
time frame: 1yr post-sugery
UCLA Activity Score
time frame: 6mths post-surgery
UCLA Activity Score
time frame: 1yr post-surgery
Hip Outcome Score
time frame: 6mths post-surgery
Hip Outcome Score
time frame: 1yr post-surgery
EuroQol EQ-5D
time frame: 6mths post-surgery
EuroQol EQ-5D
time frame: 1yr post-surgery
Oxford Hip Score
time frame: 2yrs post-surgery
Oxford Hip Score
time frame: 3yrs post-surgery
Oxford Hip Score
time frame: 4yrs post-surgery
Oxford Hip Score
time frame: 5yrs post-surgery
Oxford Hip Score
time frame: 6yrs post-surgery
Oxford Hip Score
time frame: 7yrs post-surgery
Oxford Hip Score
time frame: 8yrs post-surgery
Oxford Hip Score
time frame: 9yrs post surgery
Oxford Hip Score
time frame: 10yrs post-surgery
Oxford Hip Score
time frame: 11yrs post-surgery
Oxford Hip Score
time frame: 12yrs post-surgery
Oxford Hip Score
time frame: 13yrs post-sugery
Oxford Hip Score
time frame: 14yrs post-surgery
Oxford Hip Score
time frame: 15yrs post-surgery
UCLA Activity Score
time frame: 2yrs post-surgery
UCLA Activity Score
time frame: 3yrs post-surgery
UCLA Activity Score
time frame: 4yrs post-surgery
UCLA Activity Score
time frame: 5yrs post-surgery
UCLA Activity Score
time frame: 6yrs post-surgery
UCLA Activity Score
time frame: 7yrs post-surgery
UCLA Activity Score
time frame: 8yrs post-surgery
UCLA Activity Score
time frame: 9yrs post-surgery
UCLA Activity Score
time frame: 10yrs post-surgery
UCLA Activity Score
time frame: 11yrs post-surgery
UCLA Activity Score
time frame: 12yrs post-surgery
UCLA Activity Score
time frame: 13yrs post-surgery
UCLA Activity Score
time frame: 14yrs post-surgery
UCLA Activity Score
time frame: 15yrs post-surgery
Hip Outcome Score
time frame: 2yrs post-surgery
Hip Outcome Score
time frame: 3yrs post-surgery
Hip Outcome Score
time frame: 4yrs post-surgery
Hip Outcome Score
time frame: 5yrs post-surgery
Hip Outcome Score
time frame: 6yrs post-surgery
Hip Outcome Score
time frame: 7yrs post-surgery
Hip Outcome Score
time frame: 8yrs post-surgery
Hip Outcome Score
time frame: 9yrs post-surgery
Hip Outcome Score
time frame: 10yrs post-surgery
Hip Outcome Score
time frame: 11yrs post-surgery
Hip Outcome Score
time frame: 12yrs post-surgery
Hip Outcome Score
time frame: 13yrs post-surgery
Hip Outcome Score
time frame: 14yrs post-surgery
Hip Outcome Score
time frame: 15yrs post-surgery
EuroQol EQ-5D
time frame: 2yrs post-surgery
EuroQol EQ-5D
time frame: 3yrs post-surgery
EuroQol EQ-5D
time frame: 4yrs post-surgery
EuroQol EQ-5D
time frame: 5yrs post-surgery
EuroQol EQ-5D
time frame: 6yrs post-surgery
EuroQol EQ-5D
time frame: 7yrs post-surgery
EuroQol EQ-5D
time frame: 8yrs post-surgery
EuroQol EQ-5D
time frame: 9yrs post-surgery
EuroQol EQ-5D
time frame: 10yrs post-surgery
EuroQol EQ-5D
time frame: 11yrs post-surgery
EuroQol EQ-5D
time frame: 12yrs post-surgery
EuroQol EQ-5D
time frame: 13yrs post-surgery
EuroQol EQ-5D
time frame: 14yrs post-surgery
EuroQol EQ-5D
time frame: 15yrs post-surgery

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by DePuy International.