A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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)
xi) Subjects with a known history of poor compliance to medical treatment.
Trial design
Primary purpose
Allocation
Interventional model
Masking
317 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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