Efficacy of a New Resurfacing Hip Prosthesis

Phase 3CompletedNCT00391937

Erasmus Medical Center150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Osteoarthritis, Hip

Interventions

Articular Surface Replacement (ASR) hip prosthesisDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (6)

Laurentius Hospital

Roermond, Limburg, Netherlands

Maxima Medical Center, location Eindhoven

Eindhoven, North Brabant, Netherlands

Medical Center Haaglanden, location Antoniushove

Leidschendam, South Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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