Efficacy of a New Resurfacing Hip Prosthesis

Phase 3

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Device: Articular Surface Replacement (ASR) hip prosthesis

• Registration Number: NCT00391937
• Lead Sponsor: Erasmus Medical Center

Brief 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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Primary Completion: 2012-02
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Articular Surface Replacement (ASR) hip prosthesis	ASR prosthesis placed by conventional method
1	Articular Surface Replacement (ASR) hip prosthesis	ASR prosthesis placed using CAS

Primary Outcome Measures

Name	Time	Method
pre planned position of the femoral component preoperatively (stem-shaft-angle)	within 8 weeks before surgery
actual position of the femoral component postoperatively (stem-shaft-angle)	within one week after surgery

Secondary Outcome Measures

Name	Time	Method
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Quality of life	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Early complications	within 3 months after surgery
Harris Hip Score	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
Hip pain	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Later complications	longer than 3 months after surgery
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

Trial Locations

Locations (6)

Medical Center Haaglanden, location Westeinde Hospital; 🇳🇱 Den Haag, South Holland, Netherlands

Laurentius Hospital; 🇳🇱 Roermond, Limburg, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, South Holland, Netherlands

Maxima Medical Center, location Eindhoven; 🇳🇱 Eindhoven, North Brabant, Netherlands

Medical Center Haaglanden, location Antoniushove; 🇳🇱 Leidschendam, South Holland, Netherlands

Oosterschelde Hospital; 🇳🇱 Goes, Zeeland, Netherlands