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

Phase 3

Terminated

• Conditions: Post-traumatic Arthritis; Collagen Disorders; Traumatic Femoral Fractures; Congenital Hip Dysplasia; Osteoarthritis; Avascular Necrosis; Nonunion of Femoral Fractures; Slipped Capital Femoral Epiphysis; Perthes Disease
• Interventions: Device: CLS Spotorno; Device: European Hip; Device: Zweymüller

• Registration Number: NCT00208468
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 317

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLS Spotorno	CLS Spotorno	A cementless femoral component for use in total hip replacement
European Hip	European Hip	A cementless femoral component for use in total hip replacement
Zweymüller	Zweymüller	A cementless femoral component for use in total hip replacement

Primary Outcome Measures

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

Name	Time	Method
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.	3 Months post-op	The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices	24 months post-op	The Harris Hip Score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This post market study was terminated early; therefore the 5 and 10 year data was not collected
To compare Brooker Ectopic Ossification between subjects receiving the European, Spotorno, and Zweymuller hip devices.	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
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	This post-market study was terminated early; therefore the 5 \& 10 year data was not collected
Progressive Osteolysis - Femur: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
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	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Implant survivorship at 5 and 10 years.	5 & 10 year post-op	This post market study was terminated early; therefore the 5 and 10 year data was not collected.
Migration - Femoral: To compare Progressive Migration incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This study was terminated early; therefore the 5 \& 10 year data was not collected
Progressive Osteolysis - Acetabulum: To compare Progressive Osteolysis incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
To compare Acetabular Socket Wear between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices	5& 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
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	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
Migration - Acetabular: To compare Progressive Migration between subjects receiving the European, Spotorno, and Zweymuller hip devices	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected
To compare Femoral Stem Orientation between subjects receiving the European, Spotorno, and Zweymuller hip devices.	5 & 10 years post-op	This post market study was terminated early; therefore the 5 \& 10 year data was not collected

Trial Locations

Locations (3)

Univ. Kliniken; 🇦🇹 Graz, Austria

Univesitätsklinikum Jena; 🇩🇪 Eisenberg, Germany

InstitutoAzienda Gaetano Pini; 🇮🇹 Milan, Italy