Efficacy of a New Resurfacing Hip Prosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty

NCT00253877

Osteoarthritis

COMPLETED NA

Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study

NCT06263569

Hip Osteoarthritis

COMPLETED

Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty

NCT05265858

Hip Osteoarthritis Total Hip Arthroplasty

UNKNOWN

Mobility Assessment of Patients With Total Hip Arthroplasty

NCT00664508

Osteoarthritis Arthroplasty Hip Replacement

ACTIVE_NOT_RECRUITING NA

RSA-Study of Cemented Hip Prostheses With Five Different Articulations

NCT00698672

Arthritis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ASR prosthesis placed using CAS

Group Type EXPERIMENTAL

Articular Surface Replacement (ASR) hip prosthesis

Intervention Type DEVICE

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.

2

ASR prosthesis placed by conventional method

Group Type ACTIVE_COMPARATOR

Articular Surface Replacement (ASR) hip prosthesis

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No