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Efficacy of a New Resurfacing Hip Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00391937
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : March 1, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

October 24, 2006
October 25, 2006
March 1, 2013
October 2006
February 2012   (Final data collection date for primary outcome measure)
  • pre planned position of the femoral component preoperatively (stem-shaft-angle) [ Time Frame: within 8 weeks before surgery ]
  • actual position of the femoral component postoperatively (stem-shaft-angle) [ Time Frame: within one week after surgery ]
  • pre planned position of the femoral component preoperatively (stem-shaft-angle)
  • actual position of the femoral component postoperatively (stem-shaft-angle)
Complete list of historical versions of study NCT00391937 on ClinicalTrials.gov Archive Site
  • Harris Hip Score [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ]
  • Hip pain [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ]
  • Assessments of the position of femoral component (biomechanical parameters) at the X-rays [ Time Frame: preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively ]
  • Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ]
  • Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM) [ Time Frame: preoperatively and at 3 and 6 months postoperatively ]
  • Quality of life [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ]
  • Early complications [ Time Frame: within 3 months after surgery ]
  • Later complications [ Time Frame: longer than 3 months after surgery ]
  • Harris Hip Score preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
  • Hip pain preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
  • Assessments of the position of femoral component (biomechanical parameters) at the X-rays preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively
  • Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
  • Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM) preoperatively and at 3 and 6 months postoperatively
  • Quality of life preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
  • Early complications (within 3 months)
  • Later complications (longer than 3 months)
Not Provided
Not Provided
 
Efficacy of a New Resurfacing Hip Prosthesis
Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study
The purpose of this study is to compare the articular surface replacement (ASR) prosthesis placed by the conventional positioning method and the ASR prosthesis placed by 'computer assisted surgery' (CAS) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. The hypothesis is that this variation is larger with the conventional positioning method than when CAS is used.

For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. However, because of the life expectation and high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution.

An alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (CAS). The hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when CAS is used.

This study will compare the results of those who had an ASR prosthesis placed by the conventional positioning method with those patients in whom the ASR prosthesis was placed using CAS.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Hip
Device: Articular Surface Replacement (ASR) hip prosthesis
a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.
  • Experimental: 1
    ASR prosthesis placed using CAS
    Intervention: Device: Articular Surface Replacement (ASR) hip prosthesis
  • Active Comparator: 2
    ASR prosthesis placed by conventional method
    Intervention: Device: Articular Surface Replacement (ASR) hip prosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2013
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men aged ≤ 60 years, and women aged ≤ 55 years
  • Presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery

Exclusion Criteria:

  • Evident osteoporosis
  • Active local or systemic infection
  • Clinical manifestation of vascular deficiency of the lower extremity
  • Pathological condition of the acetabulum
  • Presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, Legg-Calve- Perthes disease
  • Rheumatoid arthritis
  • Extreme varus position (neck-shaft angle < 110º)
  • Presence of femoral cyst > 1 cm in diameter
  • Previous hip surgery
  • Presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year
  • Presence of a THR at the contra lateral site less than 6 months post- operatively or patients with a THR at the contra lateral site with a poor function of the hip
  • BMI> 30 kg/m2
  • Renal deficiency (creatine > 115 μmol/l for men and > 90 μmol/l for women)
  • Medically proven metal allergy
  • Request of patient to correct an existing leg length discrepancy
  • Head-neck ratio < 1
  • Use of steroids, and/or immunosuppressive medication
  • Alcoholism
  • Patients from which it is not sure that they will be able to attend the follow-up measurements
  • Insufficient command of the Dutch language, spoken and/of written
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00391937
06-DP-001
Not Provided
Not Provided
Not Provided
maaike vissers, Erasmus Medical Center
Erasmus Medical Center
Johnson & Johnson
Study Director: JAN Verhaar, PhD MD Erasmus Medical Center
Erasmus Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP