Overview

This trial is active, not recruiting.

Conditions arthritis, avascular necrosis
Treatments anterolateral approach, posterior approach, recap total hip resurfacing
Sponsor Biomet U.K. Ltd.
Start date September 2008
End date July 2013
Trial size 49 participants
Trial identifier NCT00750984, BMETEU.CR.EU9

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
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.
recap total hip resurfacing
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
(Active Comparator)
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
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.
recap total hip resurfacing
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Primary Outcomes

Measure
RSA
time frame: 1 week, 3 months, 1 year, 2 years, 5 years

Secondary Outcomes

Measure
Harris Hip Score
time frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
Microdialysis
time frame: 1 week
Conventional X-ray
time frame: 1 week
Gait Analysis
time frame: 1 week, 3 months, 1 year
DEXA scan
time frame: Pre-operatively, 1 week, 1 year, 2 years

Eligibility Criteria

Male or female participants from 29 years up to 61 years old.

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

Additional Information

Official title A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Principal investigator Thomas Pryno, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..