A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Zimmer Biomet

Status: Completed

Conditions: Arthritis; Avascular Necrosis

Treatments: Procedure: Anterolateral approach; Procedure: Posterior approach; Device: ReCap Total Hip Resurfacing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00750984

BMETEU.CR.EU9

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 29 to 61 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

1

Experimental group

Description:

This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Treatment:

Device: ReCap Total Hip Resurfacing

Procedure: Anterolateral approach

Device: ReCap Total Hip Resurfacing

2

Active Comparator group

Description:

This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Treatment:

Device: ReCap Total Hip Resurfacing

Procedure: Posterior approach

Device: ReCap Total Hip Resurfacing