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A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

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

NCT00208468•DePuy International

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 75 years

Sex

ALL

Healthy 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)
+1 more criteria

Locations (3)

Univ. Kliniken

Graz, Austria

Univesitätsklinikum Jena

Eisenberg, Germany

InstitutoAzienda Gaetano Pini

Milan, Italy

Key Dates

Start Date

February 1, 2000

Primary Completion Date

June 1, 2005

Completion Date

March 1, 2015

Last Updated

October 7, 2016

Enrollment

317

ACTUAL participants

Conditions

OsteoarthritisPost-traumatic ArthritisCollagen DisordersAvascular NecrosisTraumatic Femoral FracturesNonunion of Femoral FracturesCongenital Hip DysplasiaSlipped Capital Femoral EpiphysisPerthes Disease

Interventions

European Hip

DEVICE

Zweymüller

DEVICE

CLS Spotorno

DEVICE

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

Inclusion Criteria

Exclusion Criteria

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