A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
Primary Purpose
Osteonecrosis, Femoral Neck Fracture, Implant Failure
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Surgical approach (ReCap Hip Resurfacing System)
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring osteonecrosis, femoral neck fracture, implant fixation, implant failure, periprosthetic bone mineral density, gait function, gait analysis, patient recovery
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;
- 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.
Sites / Locations
- Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Posterior approach
Anterolateral approach
Arm Description
Posterior surgical approach in hip resurfacing arthroplasty
Anterolateral surgical approach in hip resurfacing arthroplasty
Outcomes
Primary Outcome Measures
femoral head blood flow, evaluated by Laser Doppler Flowmetry
femoral head metabolism, evaluated by microdialysis
Secondary Outcome Measures
implant fixation, evaluated by RSA (radiostereogrammetric analysis)
periprosthetic bone mineral density, evaluated by DEXA
gait function, evaluated by gait analysis
patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale
Full Information
NCT ID
NCT00913679
First Posted
June 2, 2009
Last Updated
December 14, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT00913679
Brief Title
A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
Official Title
A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2008 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
November 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Zimmer Biomet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis, Femoral Neck Fracture, Implant Failure
Keywords
osteonecrosis, femoral neck fracture, implant fixation, implant failure, periprosthetic bone mineral density, gait function, gait analysis, patient recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior approach
Arm Type
Active Comparator
Arm Description
Posterior surgical approach in hip resurfacing arthroplasty
Arm Title
Anterolateral approach
Arm Type
Active Comparator
Arm Description
Anterolateral surgical approach in hip resurfacing arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Surgical approach (ReCap Hip Resurfacing System)
Other Intervention Name(s)
ReCap Hip Resurfacing System
Intervention Description
two different surgical approaches in hip resurfacing arthroplasty
Primary Outcome Measure Information:
Title
femoral head blood flow, evaluated by Laser Doppler Flowmetry
Time Frame
during surgery
Title
femoral head metabolism, evaluated by microdialysis
Time Frame
3 days
Secondary Outcome Measure Information:
Title
implant fixation, evaluated by RSA (radiostereogrammetric analysis)
Time Frame
postoperatively; 3 months; 1,2 and 5 years
Title
periprosthetic bone mineral density, evaluated by DEXA
Time Frame
pre- and postoperatively; 1 and 2 years
Title
gait function, evaluated by gait analysis
Time Frame
preoperatively; 3 months and 1 year
Title
patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale
Time Frame
preoperatively and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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;
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.
Facility Information:
Facility Name
Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2
City
Aarhus C
State/Province
Aarhus County
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
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