A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Arthritis Clinical Trial

Official title:

A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750984
• Other study ID #: BMETEU.CR.EU9
• Status: Completed
• Phase: N/A
• First received: September 10, 2008
• Last updated: January 9, 2018
• Start date: September 2008
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2017
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Necrosis

Intervention

Procedure:
• 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.
• 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.

Device:
• ReCap Total Hip Resurfacing
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
• ReCap Total Hip Resurfacing
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Arhus

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSA		1 week, 3 months, 1 year, 2 years, 5 years
Secondary	Harris Hip Score		Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
Secondary	Microdialysis		1 week
Secondary	Conventional X-ray		1 week
Secondary	Gait Analysis		1 week, 3 months, 1 year
Secondary	DEXA scan		Pre-operatively, 1 week, 1 year, 2 years