Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury, Arthroplasty Complications
Conditions
Keywords
abductor, approach, limp, Trendelenburg, gluteus medius
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELateral approach
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
PROCEDUREPosterior approach
Total hip arthroplasty performed through a posterior surgical approach (Moore)
Sponsors
Vastra Gotaland Region
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty. * Ability to understand and write swedish.
Exclusion criteria
* Impaired funktion of the contralateral hip or knees causing limping. * Neuromuscular diseases * Postoperative leg length discrepancy excceding 1 cm * Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trendelenburg sign as binary variable (positive/negative) | At 12 months after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | Intraoperative | Bleeding during total hip arthroplasty measured in ml |
| Periprosthetic infection | Within 12 months from intervention | Incidens of deep surgical wound infection |
| Oxford Hip Score | At 3 months after intervention | Patient-reported hip function measured in a scale of 0-48 |
| Euroqol 5 dimension 5 level index (EQ5D-5L) | At 3 months after intervention | Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1 |
| Euroqol visual analog scale (EQVAS) | At 3 months after intervention | Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100 |
| Dislocation | Within 12 months from intervention | Incidens of postoperative dislocation |
| Gluteus medius avulsion in ultrasound | At 3 months after intervention | 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 |
| Gluteus medius atrophy in Magnetic Resonance Imaging | At 3 months after intervention | 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) |
| Hip abuction torque | At 3 months after intervention | Hip abuction torque measured in Nm/Kg with gate analysis |
| Trendelenburg sign as binary variable (positive/negative) | At 3 months after intervention | 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. |
| University of California Activity Level (UCLA) | At 3 months after intervention | Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10 |
Countries
Sweden
Contacts
Primary ContactGeorgios Tsikandylakis, MD PhD
Outcome results
None listed