A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Aarhus University Hospital
Biomet, Inc.
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00913679
First received: June 2, 2009
Last updated: November 3, 2011
Last verified: November 2011

June 2, 2009
November 3, 2011
November 2008
November 2013   (final data collection date for primary outcome measure)
  • femoral head blood flow, evaluated by Laser Doppler Flowmetry [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • femoral head metabolism, evaluated by microdialysis [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913679 on ClinicalTrials.gov Archive Site
  • implant fixation, evaluated by RSA (radiostereogrammetric analysis) [ Time Frame: postoperatively; 3 months; 1,2 and 5 years ] [ Designated as safety issue: No ]
  • periprosthetic bone mineral density, evaluated by DEXA [ Time Frame: pre- and postoperatively; 1 and 2 years ] [ Designated as safety issue: No ]
  • gait function, evaluated by gait analysis [ Time Frame: preoperatively; 3 months and 1 year ] [ Designated as safety issue: No ]
  • patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale [ Time Frame: preoperatively and 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty

The purpose of the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.

BACKGROUND:

6700 total hip replacements are performed each year in Denmark due to osteoarthritis. Young patients sustain a substantial risk of early implant failure due to high-activity daily living, and among patients younger than 55 years at surgery 20 percent need revision surgery within ten years. Revision surgery is more complicated than primary surgery and associated with decreased implant longevity due to decreased bone stock. Resurfacing hip arthroplasty (RHA), restores the anatomy of the hip as only the articulating joint surfaces are replaced, and thus more bone is left to ensure a better opportunity of successful revision surgery later on. The clinical midterm evaluation of RHA survival is promising, but two major complications leading to early revision, namely osteonecrosis and femoral neck fracture, has raised concern regarding the influence of surgical technique on the vascularity of the femoral head. RHA is commonly performed through a posterolateral surgical approach. By this technique muscle tendons are spilt resulting in decreased patient mobility for several weeks after surgery, but more importantly, the blood supply is compromised as a large artery has to be ligated. This is speculated to decrease the blood supply to femoral head and neck and thereby increase the risk of osteonecrosis, femoral neck fracture, and implant failure. With a new surgical technique facilitating an anterolateral approach to the hip joint the blood supply is left intact as well as the muscle tendons.

HYPOTHESIS:

An anterolateral surgical approach in resurfacing hip arthroplasty will 1) preserve the blood supply to the femoral head and neck and improve implant longevity, and 2) spare the muscle tendons and ease patient recovery.

METHOD and FACILITIES:

50 patients, aged 30 to 60 years, with osteoarthrosis of the hip will be randomised to a RHA inserted by either an anterolateral or a posterolateral surgical approach. Primary points of evaluation are 1) blood supply to the femoral head and neck measured intraoperatively by Laser Doppler flowmetry and postoperatively by microdialysis established during surgery. Secondary points of evaluation are 1) implant fixation measured by radiostereometric analysis (RSA), and 2) periprosthetic bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA), 3) gait analysis and 4) clinical scores of function, pain and activities of daily living (Harris Hip Score , Visual Analogue Scale).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Osteonecrosis
  • Femoral Neck Fracture
  • Implant Failure
Procedure: Surgical approach (ReCap Hip Resurfacing System)
two different surgical approaches in hip resurfacing arthroplasty
Other Name: ReCap Hip Resurfacing System
  • Active Comparator: Posterior approach
    Posterior surgical approach in hip resurfacing arthroplasty
    Intervention: Procedure: Surgical approach (ReCap Hip Resurfacing System)
  • Active Comparator: Anterolateral approach
    Anterolateral surgical approach in hip resurfacing arthroplasty
    Intervention: Procedure: Surgical approach (ReCap Hip Resurfacing System)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2013
November 2013   (final data collection date for primary outcome measure)

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;
  • Age 30 to 60 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 postoperatively;
  • 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-diuretics;
  • Alcoholism, females over 14 units per week, males over 21 units per week; AVN;
  • Osteoporosis.
Both
30 Years to 60 Years
No
Contact: Nina Dyrberg Lorenzen, MD + 45 8949 7885 nina.dyrberg.lorenzen@ki.au.dk
Contact: Kjeld Søballe, Professor, Dr. Med, MD +45 8949 7425 kjeld@soballe.com
Denmark
 
NCT00913679
20070082
Yes
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Biomet, Inc.
Not Provided
University of Aarhus
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP