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OpenTrials
Completed

NCT Number: NCT00750984

A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

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Key information

Age range

29 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

About this study

Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:

  • Less bone resection, less complicated revision surgery.
  • Reduced stress shielding of the femur.
  • Lower incidence of hip dislocations.
  • Walking function improved by change in mobilisation regime and operative technique.
  • Risk of femoral neck fracture is reduced by preoperative measurement of bone density.
  • Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary hip OA
  • Secondary hip OA due to mild and moderate acetabular dysplasia
  • Sufficient bone quality for cementless acetabular component
  • Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
  • >29 years
  • <61 years

Exclusion criteria

  • Neuromuscular or vascular diseases in affected leg
  • Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
  • Need of NSAID post-operatively
  • Fracture sequelae
  • Females at risk of pregnancy (no safe contraceptives)
  • Severe hip dysplasia
  • Sequelae from hip disease in childhood
  • Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
  • Alcoholism (females > 14 units per week, males > 21 units per week) AVN
  • Osteoporosis

Treatment and study plan

Anterolateral approach

Procedure

The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.

Posterior Approach

Procedure

The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.

ReCap Total Hip Resurfacing

Device

This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Primary outcomes

  1. RSA

    Time frame: 1 week, 3 months, 1 year, 2 years, 5 years

Secondary outcomes

  1. Harris Hip Score

    Time frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year

  2. Microdialysis

    Time frame: 1 week

  3. Conventional X-ray

    Time frame: 1 week

  4. Gait Analysis

    Time frame: 1 week, 3 months, 1 year

  5. DEXA scan

    Time frame: Pre-operatively, 1 week, 1 year, 2 years

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2017
First posted
Sep 11, 2008
Registry last updated
Jan 11, 2018

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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