A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Zimmer Biomet49 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthritis Avascular Necrosis

Interventions

Anterolateral approachPROCEDURE

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.

Posterior approachPROCEDURE

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 ResurfacingDEVICE

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

Eligibility

Sex: ALLMin age: 29 YearsMax age: 61 Years

Medical Language ↔ Plain English

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 (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

RSA

Time frame: 1 week, 3 months, 1 year, 2 years, 5 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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