An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Traumatic Femoral Fractures
• Intervention / Treatment: Device: DePuy Proxima™ Hip

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Metz, France
    • Hospital Belle Isle
• Portugal
  • Porto, Portugal
    • Hospital de Santo António
• Spain
  • Barcelona, Spain
    • Hospital Clinic Barcelona
• United Kingdom
  • Boston, United Kingdom
    • Pilgrim Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DePuy Proxima™ Hip; A short, anatomic, cementless femoral component for use in total hip arthroplasty	Device: DePuy Proxima™ Hip; A short, anatomic, cementless femoral component for use in total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship calculated at the five-year time-point	5yrs post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; Hip; Cementless; Conservative; Anatomic
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Femoral Fractures; Arthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: CT07/02