A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement

DePuy International3 sites in 3 countries317 target enrollmentFebruary 2000

ConditionsOsteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis Perthes Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: DePuy International
Enrollment: 317
Locations: 3
Primary Endpoint: To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

Registry

clinicaltrials.gov

Start Date

February 2000

End Date

March 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DePuy International

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime.
•ii) Age - The subject's age is between 18 and 75 years inclusive.
•iii) Sex - Male or female subjects may be recruited to the study.
•iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease.
•v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.

Exclusion Criteria

•i) Subjects undergoing revision procedure to the operative hip.
•ii) Subjects who have had a previous femoral osteotomy to the operative hip.
•iii) Subjects who have a history of active sepsis in the joint.
•iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
•v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease.
•vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.
•vii) Subject's whose weight is \> 100kg.
•viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).
•ix) Subjects who have a fracture of the femur \> 6 months old (RSA and DEXA subjects only).
•x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)

Outcomes

Primary Outcomes

To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.

Time Frame: 2yrs post-surgery

Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason.

Secondary Outcomes

To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.(3 Months post-op)
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices(24 months post-op)
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.(5 & 10 years post-op)
Progressive Radiolucent Zone(s) - Acetabulum: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 year post-op)
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
Trochanteric Non-Union - Femur: To compare Trochanteric Non-union incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
Implant survivorship at 5 and 10 years.(5 & 10 year post-op)
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices(5& 10 years post-op)
Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices(5 & 10 years post-op)
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.(5 & 10 years post-op)