Efficacy of a New Resurfacing Hip Prosthesis

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
maaike vissers, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00391937
First received: October 24, 2006
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Hip
Device: Articular Surface Replacement (ASR) hip prosthesis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • pre planned position of the femoral component preoperatively (stem-shaft-angle) [ Time Frame: within 8 weeks before surgery ] [ Designated as safety issue: No ]
  • actual position of the femoral component postoperatively (stem-shaft-angle) [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ] [ Designated as safety issue: No ]
  • Hip pain [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ] [ Designated as safety issue: No ]
  • Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM) [ Time Frame: preoperatively and at 3 and 6 months postoperatively ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively ] [ Designated as safety issue: No ]
  • Early complications [ Time Frame: within 3 months after surgery ] [ Designated as safety issue: No ]
  • Later complications [ Time Frame: longer than 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2006
Study Completion Date: January 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ASR prosthesis placed using CAS
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.
Active Comparator: 2
ASR prosthesis placed by conventional method
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00391937

Locations
Netherlands
Laurentius Hospital
Roermond, Limburg, Netherlands, 6043 CV
Maxima Medical Center, location Eindhoven
Eindhoven, North Brabant, Netherlands, 5600 PD
Medical Center Haaglanden, location Westeinde Hospital
Den Haag, South Holland, Netherlands, 2501 CK
Medical Center Haaglanden, location Antoniushove
Leidschendam, South Holland, Netherlands, 2260 AK
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA
Oosterschelde Hospital
Goes, Zeeland, Netherlands, 4462 RA
Sponsors and Collaborators
Erasmus Medical Center
Johnson & Johnson
Investigators
Study Director: JAN Verhaar, PhD MD Erasmus Medical Center
  More Information

No publications provided

Responsible Party: maaike vissers, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00391937     History of Changes
Other Study ID Numbers: 06-DP-001
Study First Received: October 24, 2006
Last Updated: February 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
"resurfacing hip" [MESH]
"conventional position method"
"surgery, computer-assisted" [MESH]

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014