A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Not Applicable

Completed

• Conditions: Arthritis; Avascular Necrosis
• Interventions: Procedure: Anterolateral approach; Procedure: Posterior approach; Device: ReCap Total Hip Resurfacing

• Registration Number: NCT00750984
• Lead Sponsor: Zimmer Biomet

Brief Summary

This study compares the posterior approach to the anterolateral 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-11
• Primary Completion: 2013-07
• Status Verified: 2016-09
• Study Completion: 2017-02
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anterolateral approach	This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
1	ReCap Total Hip Resurfacing	This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
2	Posterior approach	This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
2	ReCap Total Hip Resurfacing	This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Primary Outcome Measures

Name	Time	Method
RSA	1 week, 3 months, 1 year, 2 years, 5 years

Secondary Outcome Measures

Name	Time	Method
Microdialysis	1 week
DEXA scan	Pre-operatively, 1 week, 1 year, 2 years
Conventional X-ray	1 week
Gait Analysis	1 week, 3 months, 1 year
Harris Hip Score	Pre-operatively, 1 week, 6 weeks, 3 months, 1 year

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Arhus, Denmark