A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis; Avascular Necrosis
Intervention: Anterolateral approach (Procedure); Posterior approach (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Biomet U.K. Ltd. Official(s) and/or principal investigator(s):
Thomas Pryno, MD, Principal Investigator, Affiliation: Aarhus University Hospital
Kjeld Soeballe, MD, PhD, Principal Investigator, Affiliation: Aarhus University Hospital
Overall contact:
David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com
Summary
This study compares the posterior approach to the anterolateral approach using the ReCap®
Total Hip Resurfacing System.
Clinical Details
Official title: A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: RSA
Secondary outcome: Harris Hip ScoreMicrodialysis Conventional X-ray Gait Analysis DEXA scan
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
Minimum age: 29 Years.
Maximum age: 61 Years.
Gender(s): Both.
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
Locations and Contacts
David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com
Aarhus University Hospital, Arhus, Denmark; Recruiting
Kjeld Soballe, MD, PhD, Phone: (+45) 89497425, Email: kjeld.soeballe@as.aaa.dk
Thomas Pryno, MD, Email: pryno@as.aaa.dk
Thomas Pryno, MD, Principal Investigator
Kjeld Soballe, MD, PhD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: July 2013
Last updated: September 10, 2008
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