A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

NCT00208455 | Terminated Phase 4

• 1 other identifier: CT03/09
• Study Type: interventional
• Target: 184
• 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. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

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

  5 yrs

Secondary Outcomes (4)

• Annual Kaplan-Meier survivorship calculations

  Annually

• Harris Hip Score

  6mths, 1yr, 2yrs, 5yrs, 7 yrs, 10yrs and 15 yrs post-surgery

• Radiographic analysis

  6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

• Oxford Hip score

  6mths, and annually 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:

• i) Male or female subjects between 18 and 70 years of age.
• ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• iii) 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.
• iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis.

You may not qualify if:

• i) 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.
• ii) Women who are pregnant.
• iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
• v) Subjects who are currently involved in any injury litigation claims.
• vi) Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip.
• vii) Subjects undergoing a simultaneous bilateral hip operation.
• viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
• ix) 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

Sponsors & Collaborators

• DePuy International: lead

Study Sites (4)

Asklepios Klinikum

Bad Abbach, Germany

Location

Ospedale San Pietro

Rome, Italy

Location

Arnau de Vilanova

Valencia, Spain

Location

North Bristol NHS Trust

Bristol, 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: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2005
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

IT (1); ES (1); DE (1); GB (1)