A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty

A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty

The purpose of the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.

Study Overview

• Status: Completed
• Conditions: Osteonecrosis; Femoral Neck Fracture; Implant Failure
• Intervention / Treatment: Procedure: Surgical approach (ReCap Hip Resurfacing System)

Detailed Description

BACKGROUND:

6700 total hip replacements are performed each year in Denmark due to osteoarthritis. Young patients sustain a substantial risk of early implant failure due to high-activity daily living, and among patients younger than 55 years at surgery 20 percent need revision surgery within ten years. Revision surgery is more complicated than primary surgery and associated with decreased implant longevity due to decreased bone stock. Resurfacing hip arthroplasty (RHA), restores the anatomy of the hip as only the articulating joint surfaces are replaced, and thus more bone is left to ensure a better opportunity of successful revision surgery later on. The clinical midterm evaluation of RHA survival is promising, but two major complications leading to early revision, namely osteonecrosis and femoral neck fracture, has raised concern regarding the influence of surgical technique on the vascularity of the femoral head. RHA is commonly performed through a posterolateral surgical approach. By this technique muscle tendons are spilt resulting in decreased patient mobility for several weeks after surgery, but more importantly, the blood supply is compromised as a large artery has to be ligated. This is speculated to decrease the blood supply to femoral head and neck and thereby increase the risk of osteonecrosis, femoral neck fracture, and implant failure. With a new surgical technique facilitating an anterolateral approach to the hip joint the blood supply is left intact as well as the muscle tendons.

HYPOTHESIS:

An anterolateral surgical approach in resurfacing hip arthroplasty will 1) preserve the blood supply to the femoral head and neck and improve implant longevity, and 2) spare the muscle tendons and ease patient recovery.

METHOD and FACILITIES:

50 patients, aged 30 to 60 years, with osteoarthrosis of the hip will be randomised to a RHA inserted by either an anterolateral or a posterolateral surgical approach. Primary points of evaluation are 1) blood supply to the femoral head and neck measured intraoperatively by Laser Doppler flowmetry and postoperatively by microdialysis established during surgery. Secondary points of evaluation are 1) implant fixation measured by radiostereometric analysis (RSA), and 2) periprosthetic bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA), 3) gait analysis and 4) clinical scores of function, pain and activities of daily living (Harris Hip Score , Visual Analogue Scale).

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

Contacts and Locations

• Study Contact: Name: Nina Dyrberg Lorenzen, MD; Phone Number: + 45 8949 7885; Email: nina.dyrberg.lorenzen@ki.au.dk
• Study Contact Backup: Name: Kjeld Søballe, Professor, Dr. Med, MD; Phone Number: +45 8949 7425; Email: kjeld@soballe.com

Study Locations

• Denmark
  • Aarhus County
    • Aarhus C, Aarhus County, Denmark, 8000
      • Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 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;
• Age 30 to 60 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 postoperatively;
• 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-diuretics;
• Alcoholism, females over 14 units per week, males over 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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Posterior approach; Posterior surgical approach in hip resurfacing arthroplasty	Procedure: Surgical approach (ReCap Hip Resurfacing System); two different surgical approaches in hip resurfacing arthroplasty; Other Names: ReCap Hip Resurfacing System
Active Comparator: Anterolateral approach; Anterolateral surgical approach in hip resurfacing arthroplasty	Procedure: Surgical approach (ReCap Hip Resurfacing System); two different surgical approaches in hip resurfacing arthroplasty; Other Names: ReCap Hip Resurfacing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
femoral head blood flow, evaluated by Laser Doppler Flowmetry	during surgery
femoral head metabolism, evaluated by microdialysis	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
implant fixation, evaluated by RSA (radiostereogrammetric analysis)	postoperatively; 3 months; 1,2 and 5 years
periprosthetic bone mineral density, evaluated by DEXA	pre- and postoperatively; 1 and 2 years
gait function, evaluated by gait analysis	preoperatively; 3 months and 1 year
patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale	preoperatively and 3 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): February 20, 2017
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: osteonecrosis; femoral neck fracture; implant fixation; implant failure; periprosthetic bone mineral density; gait function; gait analysis; patient recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Fractures, Bone; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures; Osteonecrosis
• Other Study ID Numbers: 20070082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No