A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

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

Study Overview

• Status: Completed
• Conditions: Arthritis; Avascular Necrosis
• Intervention / Treatment: Procedure: Anterolateral approach; Device: ReCap Total Hip Resurfacing; Device: ReCap Total Hip Resurfacing; Procedure: Posterior approach

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Arhus, Denmark
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 61 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.	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.; Device: ReCap Total Hip Resurfacing; This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.; Device: ReCap Total Hip Resurfacing; This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Active Comparator: 2; This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.	Device: ReCap Total Hip Resurfacing; This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.; Device: ReCap Total Hip Resurfacing; This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RSA	1 week, 3 months, 1 year, 2 years, 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Thomas Pryno, MD, Aarhus University Hospital; Principal Investigator: Kjeld Soeballe, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 10, 2008
• First Submitted That Met QC Criteria: September 10, 2008
• First Posted (Estimate): September 11, 2008

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: BMETEU.CR.EU9