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

This study has been terminated.
(Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.)
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00208468
First received: September 13, 2005
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to compare the performance of the Future hip, Omniflex hip, Zweymϋller hip and CLS Spotorno hip in the treatment of patients with hip joint disease requiring a total hip replacement. The first 100 subjects who enter the study will receive the Future hip. The next 300 patients who enter the study will be randomly allocated to the Future hip, Omniflex hip (Italy only), Zweymϋller hip (Austria only) or CLS Spotorno hip (Germany only). All patients will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored and special x-rays which allow the stability of the implant to be determined.


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Perthes Disease
Device: Future Hip
Device: Omniflex
Device: Zueymüller
Device: CLS Spotorno
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Implant survivorship at two years [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implant survivorship at 5 and 10 years. [ Time Frame: 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: Yes ]
  • Operative and post-operative complications [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 3yrs(RSA/DEXA patients only), 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 3yrs, 4yrs, 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiological Assessment [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs (RSA/DEXA patients only), 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • RSA x-rays [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • DEXA analysis (at immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery). [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]

Enrollment: 312
Study Start Date: February 2000
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) Future Hip
A cementless femoral component for use in total hip replacement
Device: Future Hip
A cementless femoral component for use in total hip replacement
Active Comparator: 2) Omniflex
A cementless femoral component for use in total hip replacement
Device: Omniflex
A cementless femoral component for use in total hip replacement
Active Comparator: 3) Zueymüller
A cementless femoral component for use in total hip replacement
Device: Zueymüller
A cementless femoral component for use in total hip replacement
Active Comparator: 4) CLS Spotorno
A cementless femoral component for use in total hip replacement
Device: CLS Spotorno
A cementless femoral component for use in total hip replacement

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208468

Locations
Austria
Univ. Kliniken
Graz, Austria
Germany
Univesitätsklinikum Jena
Eisenberg, Germany
Italy
InstitutoAzienda Gaetano Pini
Milan, Italy
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: Roy Harvey, Clinical Research Manager, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00208468     History of Changes
Other Study ID Numbers: CT99/02
Study First Received: September 13, 2005
Last Updated: September 1, 2011
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by DePuy International:
Hip
Cementless

Additional relevant MeSH terms:
Femoral Fractures
Slipped Capital Femoral Epiphyses
Femur Head Necrosis
Collagen Diseases
Fractures, Bone
Hip Dislocation, Congenital
Legg-Calve-Perthes Disease
Osteoarthritis
Arthritis
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Connective Tissue Diseases
Epiphyses, Slipped
Joint Diseases
Leg Injuries
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Osteochondrodysplasias
Osteonecrosis
Rheumatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014