Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
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|ClinicalTrials.gov Identifier: NCT01506024|
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : November 16, 2018
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.
The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).
The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis||Procedure: Total hip arthroplasty direct lateral approach Procedure: Total hip arthroplasty posterior approach Procedure: Total hip arthroplasty, anterior approach||Not Applicable|
With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant.
MIS is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results|
|Actual Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: THA Direct lateral
Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)
Procedure: Total hip arthroplasty direct lateral approach
Experimental: THA Posterior
Total hip arthroplasty (THA) carried out by posterior approach (DLA)
Procedure: Total hip arthroplasty posterior approach
Experimental: THA Anterior
Total hip arthroplasty (THA) carried out by anterior approach (DLA)
Procedure: Total hip arthroplasty, anterior approach
- Muscle strength [ Time Frame: 3 months postoperatively ]Measured by 1 repetition maximum (1 RM)
- Hip joint functionality and mobility [ Time Frame: 3 months postoperatively ]Measured by patient completed questionnaires and clinician reported scores
- activity level [ Time Frame: 6 subsequent days postoperatively ]Measured by an activity monitor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506024
|St. Olavs Hospital|
|Study Director:||Lars Jacob Stovner, prof||Norwegian University of Science and Technology|