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A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

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ClinicalTrials.gov Identifier: NCT00750984
Recruitment Status : Active, not recruiting
First Posted : September 11, 2008
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Condition or disease Intervention/treatment
Arthritis Avascular Necrosis Procedure: Anterolateral approach Procedure: Posterior approach Device: ReCap Total Hip Resurfacing

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Study Start Date : September 2008
Primary Completion Date : July 2013
Estimated Study Completion Date : February 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Procedure: Anterolateral approach
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.
Device: ReCap Total Hip Resurfacing
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Active Comparator: 2
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Procedure: Posterior approach
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.
Device: ReCap Total Hip Resurfacing
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.


Outcome Measures

Primary Outcome Measures :
  1. RSA [ Time Frame: 1 week, 3 months, 1 year, 2 years, 5 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750984


Locations
Denmark
Aarhus University Hospital
Arhus, Denmark
Sponsors and Collaborators
Biomet U.K. Ltd.
Investigators
Principal Investigator: Thomas Pryno, MD Aarhus University Hospital
Principal Investigator: Kjeld Soeballe, MD, PhD Aarhus University Hospital
More Information

Responsible Party: Biomet U.K. Ltd.
ClinicalTrials.gov Identifier: NCT00750984     History of Changes
Other Study ID Numbers: BMETEU.CR.EU9
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Necrosis
Pathologic Processes