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OpenTrials
Completed

NCT Number: NCT00391937

Efficacy of a New Resurfacing Hip Prosthesis

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laurentius Hospital, Roermond, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Articular Surface Replacement (ASR) hip prosthesis

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.

Primary outcomes

  1. pre planned position of the femoral component preoperatively (stem-shaft-angle)

    Time frame: within 8 weeks before surgery

  2. actual position of the femoral component postoperatively (stem-shaft-angle)

    Time frame: within one week after surgery

Secondary outcomes

  1. Harris Hip Score

    Time frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  2. Hip pain

    Time frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  3. 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

  4. Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

    Time frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  5. Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)

    Time frame: preoperatively and at 3 and 6 months postoperatively

  6. Quality of life

    Time frame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  7. Early complications

    Time frame: within 3 months after surgery

  8. Later complications

    Time frame: longer than 3 months after surgery

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2013
First posted
Oct 25, 2006
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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