Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00913679 |
Other study ID # |
20070082 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2008 |
Est. completion date |
November 2020 |
Study information
Verified date |
December 2022 |
Source |
University of Aarhus |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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).