Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04516239 |
Other study ID # |
04132 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 2005 |
Est. completion date |
July 2020 |
Study information
Verified date |
March 2021 |
Source |
Ciusss de L'Est de l'Île de Montréal |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this double-blind prospective randomized study is to compare subjective outcome
measures and gait parameters between conventional THA using large diameter femoral heads and
total hip resurfacing
Description:
In the early 1960's Sir John Charnley revolutionized total hip arthroplasty (THA) with the
introduction of polyethylene as a bearing surface. This innovation allowed THA to become a
very successful procedure to treat degeneration of the hip joint, with excellent long term
clinical outcome and patient satisfaction.
However, this technique requires sacrifice of the whole femoral head and part of the neck.
This bone will not be available for future revision surgery, which seems inevitable in the
younger patient. THA does not always allow precise reconstitution of normal hip biomechanics.
The femoral canal is also violated, fat and cement embolism can occur and thrombogenic
material is released in the bloodstream. Postoperatively the femoral stem can cause thigh
pain, proximal stress shielding, and periprosthetic fracture may occur . Finally the use of a
28 millimeter non anatomic femoral head during conventional THA increases the risk of hip
impingement and dislocation while limiting hip range of motion.
There is renewed interest in the concept of hip resurfacing and the use of large diameter
femoral heads in total hip arthroplasty, since both these options recreate more optimal hip
biomechanics. Total hip resurfacing is less invasive than conventional THA using a femoral
stem and allows restoration of normal hip anatomy. Additionally, compared to conventional
THA, hip resurfacing has the following advantages: preservation of the femoral head and neck,
better hip stability, improved hip biomechanics (leg length, offset) and possibly better
proprioception. Since the femoral canal is not violated, there is less risk of residual thigh
pain, and patients probably have the sensation of a more normal feeling joint.
As for conventional THA with large diameter femoral heads, the use of a near anatomic head
size (compared to the small 28mm diameter head use with conventional THA) restores normal
stability, helps reduce the incidence of impingement and increases range of motion to a
greater extent than hip resurfacing, and might improve proprioception as well. The
investigators believe these advantages will have a positive influence on clinical function
and gait pattern compared to conventional THA.
Gait analysis has demonstrated that gait pattern is modified after THA and patients do not
recover normal gait. Kinematics analysis further showed that abnormal gait pattern is not
only observed in the operated hip but also in other articulations, including the contra
lateral limb. Walking kinetics are affected to some extent, especially the force generated by
the lower limb and synchronization of muscle activity. Finally a subjective feeling of an
abnormal hip function may still persists after THA.
The goal of this double-blind prospective randomized study is to compare subjective outcome
measures and gait parameters between conventional THA using large diameter femoral heads and
total hip resurfacing