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Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement
This study is currently recruiting participants.
Verified by DePuy International, September 2005
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208468
  Purpose

The objectives of this study are to evaluate the clinical and radiological performance of the Future Hip against three other hip devices currently used in standard clinical practice.


Condition Intervention Phase
Osteoarthritis, Hip
Device: Future Hip
Phase IV

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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
  Eligibility

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

Inclusion Criteria:

The inclusion criteria for this study are current indications for primary total hip arthroplasty utilising a cementless femoral component. These include pain, deformity and loss of function, which are not responsive to medical treatment. Subjects will only be considered eligible and must only be recruited if they meet all of the following criteria:

  • 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.
  • Age - The subject's age is between 18 and 75 years inclusive.
  • Sex - Male or female subjects may be recruited to the study.
  • Diagnosis - Subjects must be undergoing primary total hip replacement (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, slipped upper femoral epiphysis (SUFE), or Perthes disease.
  • 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:

  • Subjects undergoing revision procedure to the operative hip.
  • Subjects who have had a previous femoral osteotomy to the operative hip.
  • Subjects who have a history of active sepsis in the joint.
  • Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
  • 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.
  • Subjects with psycho-social disorders, which, in the opinion of the Investigator, would limit rehabilitation.
  • Subjects' weight is > 100 kg.
  • Subjects with femoral head necrosis on the non-operated side (radiostereometric analysis [RSA] and dual energy x-ray absorptiometry [DEXA] subjects only).
  • Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only).
  • Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)
  • Subjects with a known history of poor compliance to medical treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208468

Contacts
Contact: Michael Borroff, B.Sc., M.Sc. +44 113 387 7800 ext 7910 mborroff@dpygb.jnj.com

Locations
Austria
Recruiting
Graz, Austria
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, B.Sc., M.Sc. DePuy International Ltd.
  More Information

Study ID Numbers: CT9902
Study First Received: September 13, 2005
Last Updated: September 24, 2007
ClinicalTrials.gov Identifier: NCT00208468  
Health Authority: Austria: Federal Ministry for Health and Women

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases
Osteoarthritis, Hip

ClinicalTrials.gov processed this record on January 16, 2009