Efficacy of a New Resurfacing Hip Prosthesis

Osteoarthritis, Hip Clinical Trial

Official title:

Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391937
• Other study ID #: 06-DP-001
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2006
• Last updated: February 28, 2013
• Start date: October 2006
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Medical Center Haaglanden, location Westeinde Hospital	Den Haag	South Holland
Netherlands	Maxima Medical Center, location Eindhoven	Eindhoven	North Brabant
Netherlands	Oosterschelde Hospital	Goes	Zeeland
Netherlands	Medical Center Haaglanden, location Antoniushove	Leidschendam	South Holland
Netherlands	Laurentius Hospital	Roermond	Limburg
Netherlands	Erasmus Medical Center	Rotterdam	South Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Johnson & Johnson

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre planned position of the femoral component preoperatively (stem-shaft-angle)		within 8 weeks before surgery	No
Primary	actual position of the femoral component postoperatively (stem-shaft-angle)		within one week after surgery	No
Secondary	Harris Hip Score		preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively	No
Secondary	Hip pain		preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively	No
Secondary	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	No
Secondary	Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)		preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively	No
Secondary	Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)		preoperatively and at 3 and 6 months postoperatively	No
Secondary	Quality of life		preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively	No
Secondary	Early complications		within 3 months after surgery	No
Secondary	Later complications		longer than 3 months after surgery	No