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

NCT01134445 | Terminated Phase 4

• 1 other identifier: CT07/02
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 4

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.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis; Traumatic Femoral Fractures; Congenital Hip Dysplasia

Keywords

Arthroplasty; Replacement; Hip; Conservative; Anatomic; Cementless

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship calculated at the five-year time-point

  5yrs post surgery

Secondary Outcomes (95)

• 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

Study Arms (1)

DePuy Proxima™ Hip

OTHER

A short, anatomic, cementless femoral component for use in total hip arthroplasty

Device: DePuy Proxima™ Hip

Interventions

DePuy Proxima™ Hip DEVICE

A short, anatomic, cementless femoral component for use in total hip arthroplasty

DePuy Proxima™ Hip

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (4)

Hospital Belle Isle

Metz, France

Location

Hospital de Santo Antonio

Porto, Portugal

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Pilgrim Hospital

Boston, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Osteonecrosis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: June 2, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

GB (1); FR (1); PT (1); ES (1)