A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

NCT ID: NCT00750984

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2017-02-28

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.

Conditions

Arthritis; Avascular Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Anterolateral approach

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

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

2

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

Group Type: ACTIVE_COMPARATOR

Posterior approach

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

ReCap Total Hip Resurfacing

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

Intervention Type: DEVICE

ReCap Total Hip Resurfacing

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pryno, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Kjeld Soeballe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

BMETEU.CR.EU9

Identifier Type: -

Identifier Source: org_study_id