Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.
The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty. 580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
580
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
Total hip arthroplasty performed through a posterior surgical approach (Moore)
Sahlgrenska University Hospital
Mölndal, Sweden
RECRUITINGTrendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Time frame: At 12 months after intervention
Dislocation
Incidens of postoperative dislocation
Time frame: Within 12 months from intervention
Intraoperative blood loss
Bleeding during total hip arthroplasty measured in ml
Time frame: Intraoperative
Periprosthetic infection
Incidens of deep surgical wound infection
Time frame: Within 12 months from intervention
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Time frame: At 3 months after intervention
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Time frame: At 12 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Time frame: At 3 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Time frame: At 12 months after intervention
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Time frame: At 3 months after intervention
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Time frame: At 12 months after intervention
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Time frame: At 3 months after intervention
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Time frame: At 12 months after intervention
Gluteus medius avulsion in ultrasound
The proportion avulsed gluteus medius tendon in relation to the whole tendon attachment in a scale of 0 (no avulsion) to 1 (total avulsion). Measured with ultrasound
Time frame: At 3 months after intervention
Gluteus medius atrophy in Magnetic Resonance Imaging
The area of gluteus medius muscle in the operated side divided by the area of the gluteus medius muscle in the healthy side as shown in magnetic resonance imaging in a scale of 0 (complete atrophy) to 1 (no atrophy)
Time frame: At 3 months after intervention
Hip abuction torque
Hip abuction torque measured in Nm/Kg with gate analysis
Time frame: At 3 months after intervention
Trendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Time frame: At 3 months after intervention
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