Status:
TERMINATED
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Post-traumatic Arthritis
Eligibility:
All Genders
55-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
- xi) Subjects with a known history of poor compliance to medical treatment.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00208468
Start Date
February 1 2000
End Date
March 1 2015
Last Update
October 7 2016
Active Locations (3)
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1
Univ. Kliniken
Graz, Austria
2
Univesitätsklinikum Jena
Eisenberg, Germany
3
InstitutoAzienda Gaetano Pini
Milan, Italy