A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet U.K. Ltd. )
ClinicalTrials.gov Identifier:
NCT00750984
First received: September 10, 2008
Last updated: June 23, 2015
Last verified: April 2014
  Purpose
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Condition Intervention
Arthritis
Avascular Necrosis
Procedure: Anterolateral approach
Procedure: Posterior approach
Device: ReCap Total Hip Resurfacing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • RSA [ Time Frame: 1 week, 3 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Microdialysis [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Conventional X-ray [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Gait Analysis [ Time Frame: 1 week, 3 months, 1 year ] [ Designated as safety issue: No ]
  • DEXA scan [ Time Frame: Pre-operatively, 1 week, 1 year, 2 years ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: September 2008
Estimated Study Completion Date: February 2017
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   29 Years to 61 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 10, 2008
Last Updated: June 23, 2015
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2016