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

NCT00208468 | Terminated Phase 3

• 1 other identifier: CT99/02
• Study Type: interventional
• Target: 317
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Keywords

Hip; Cementless

Outcome Measures

Primary Outcomes (1)

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

  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.

  2yrs post-surgery

Secondary Outcomes (61)

• Implant survivorship at 5 and 10 years.

  5 & 10 year post-op

• 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

  6 Months post-op

• To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices

  12 months post-op

• To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices

  24 months post-op

Study Arms (3)

European Hip

OTHER

A cementless femoral component for use in total hip replacement

Device: European Hip

Zweymüller

ACTIVE COMPARATOR

A cementless femoral component for use in total hip replacement

Device: Zweymüller

CLS Spotorno

ACTIVE COMPARATOR

A cementless femoral component for use in total hip replacement

Device: CLS Spotorno

Interventions

European Hip DEVICE

A cementless femoral component for use in total hip replacement

European Hip

Zweymüller DEVICE

A cementless femoral component for use in total hip replacement

Zweymüller

CLS Spotorno DEVICE

A cementless femoral component for use in total hip replacement

CLS Spotorno

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (3)

Univ. Kliniken

Graz, Austria

Location

Univesitätsklinikum Jena

Eisenberg, Germany

Location

InstitutoAzienda Gaetano Pini

Milan, Italy

Location

MeSH Terms

Conditions

Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses; Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped; Femur Head Necrosis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2000
• Primary Completion: June 1, 2005
• Study Completion: March 1, 2015
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

IT (1); AU (1); DE (1)