Clinical trial NCT01134445: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Traumatic Femoral Fractures
Congenital Hip Dysplasia
Keywords: Arthroplasty
Replacement
Hip
Conservative
Anatomic
Cementless
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Kaplan-Meier survivorship calculated at the five-year time-point
timeFrame: 5yrs post surgery
Secondary outcomes:
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 1yr post-surgery
measure: Harris Hip Score
timeFrame: 6mths post-surgery
measure: Oxford Hip Score
timeFrame: 3mths post-surgery
measure: UCLA Activity Score
timeFrame: 3mths post-surgery
measure: Hip Outcome Score
timeFrame: 3mths post-surgery
measure: EuroQol EQ-5D
timeFrame: 3mths post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 2yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 3yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 4yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 6yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 7yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 8yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 9yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 10yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 11yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 12yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 13yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 14yrs post-surgery
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: 15yrs post-surgery
measure: Harris Hip Score
timeFrame: 1yr post-surgery
measure: Harris Hip Score
timeFrame: 2yrs post-surgery
measure: Harris Hip Score
timeFrame: 5yrs post-surgery
measure: Harris Hip Score
timeFrame: 10yrs post-surgery
measure: Harris Hip Score
timeFrame: 15yrs post-surgery
measure: Radiographic Analysis
timeFrame: 3mths post-surgery
measure: Radiographic Analysis
timeFrame: 6mths post-surgery
measure: Radiographic Analysis
timeFrame: 1yr post-surgery
measure: Radiographic Analysis
timeFrame: 2yrs post-surgery
measure: Radiographic Analysis
timeFrame: 5yrs post-surgery
measure: Radiographic Analysis
timeFrame: 10yrs post-surgery
measure: Radiographic Analysis
timeFrame: 15 yrs post-surgery
measure: Oxford Hip Score
timeFrame: 6mths post-surgery
measure: Oxford Hip Score
timeFrame: 1yr post-sugery
measure: UCLA Activity Score
timeFrame: 6mths post-surgery
measure: UCLA Activity Score
timeFrame: 1yr post-surgery
measure: Hip Outcome Score
timeFrame: 6mths post-surgery
measure: Hip Outcome Score
timeFrame: 1yr post-surgery
measure: EuroQol EQ-5D
timeFrame: 6mths post-surgery
measure: EuroQol EQ-5D
timeFrame: 1yr post-surgery
measure: Oxford Hip Score
timeFrame: 2yrs post-surgery
measure: Oxford Hip Score
timeFrame: 3yrs post-surgery
measure: Oxford Hip Score
timeFrame: 4yrs post-surgery
measure: Oxford Hip Score
timeFrame: 5yrs post-surgery
measure: Oxford Hip Score
timeFrame: 6yrs post-surgery
measure: Oxford Hip Score
timeFrame: 7yrs post-surgery
measure: Oxford Hip Score
timeFrame: 8yrs post-surgery
measure: Oxford Hip Score
timeFrame: 9yrs post surgery
measure: Oxford Hip Score
timeFrame: 10yrs post-surgery
measure: Oxford Hip Score
timeFrame: 11yrs post-surgery
measure: Oxford Hip Score
timeFrame: 12yrs post-surgery
measure: Oxford Hip Score
timeFrame: 13yrs post-sugery
measure: Oxford Hip Score
timeFrame: 14yrs post-surgery
measure: Oxford Hip Score
timeFrame: 15yrs post-surgery
measure: UCLA Activity Score
timeFrame: 2yrs post-surgery
measure: UCLA Activity Score
timeFrame: 3yrs post-surgery
measure: UCLA Activity Score
timeFrame: 4yrs post-surgery
measure: UCLA Activity Score
timeFrame: 5yrs post-surgery
measure: UCLA Activity Score
timeFrame: 6yrs post-surgery
measure: UCLA Activity Score
timeFrame: 7yrs post-surgery
measure: UCLA Activity Score
timeFrame: 8yrs post-surgery
measure: UCLA Activity Score
timeFrame: 9yrs post-surgery
measure: UCLA Activity Score
timeFrame: 10yrs post-surgery
measure: UCLA Activity Score
timeFrame: 11yrs post-surgery
measure: UCLA Activity Score
timeFrame: 12yrs post-surgery
measure: UCLA Activity Score
timeFrame: 13yrs post-surgery
measure: UCLA Activity Score
timeFrame: 14yrs post-surgery
measure: UCLA Activity Score
timeFrame: 15yrs post-surgery
measure: Hip Outcome Score
timeFrame: 2yrs post-surgery
measure: Hip Outcome Score
timeFrame: 3yrs post-surgery
measure: Hip Outcome Score
timeFrame: 4yrs post-surgery
measure: Hip Outcome Score
timeFrame: 5yrs post-surgery
measure: Hip Outcome Score
timeFrame: 6yrs post-surgery
measure: Hip Outcome Score
timeFrame: 7yrs post-surgery
measure: Hip Outcome Score
timeFrame: 8yrs post-surgery
measure: Hip Outcome Score
timeFrame: 9yrs post-surgery
measure: Hip Outcome Score
timeFrame: 10yrs post-surgery
measure: Hip Outcome Score
timeFrame: 11yrs post-surgery
measure: Hip Outcome Score
timeFrame: 12yrs post-surgery
measure: Hip Outcome Score
timeFrame: 13yrs post-surgery
measure: Hip Outcome Score
timeFrame: 14yrs post-surgery
measure: Hip Outcome Score
timeFrame: 15yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 2yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 3yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 4yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 5yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 6yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 7yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 8yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 9yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 10yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 11yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 12yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 13yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 14yrs post-surgery
measure: EuroQol EQ-5D
timeFrame: 15yrs post-surgery
Other outcomes:
Locations:
city: Metz
country: France
facility: Hospital Belle Isle
city: Porto
country: Portugal
facility: Hospital de Santo Antonio
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
Study officials:
References: