An interventional study of Lateral approach and Posterior approach in Hip Osteoarthritis, Muscle Weakness and Muscle Atrophy, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 580 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
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290 participants receive their hip prosthesis through a lateral approach. The anterior third of m. gluteus medius along with the corresponding part of m. vastus lateralis are detached from the greater trochanter and the anterior capsule is excised for the exposure of the hip joint. After implant insertion, the gluteus medius is reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.
Procedure: Lateral approach
290 participants receive their hip prosthesis through a posterior approach. The m. piriformis gemelli and obturator internus are detached from the greater trochanter and the posterior capsule is incised for the exposure of the hip joint. After implant insertion, the posterior capsule as well as m piriformis and the external rotators are reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.
Procedure: Posterior approach
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
Also known as: Gammer approach
Total hip arthroplasty performed through a posterior surgical approach (Moore)
Also known as: Moore approach
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 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
Plan to share: No
Started May 2022 (actual). Primary completion is estimated for Dec 2027, 67 months after the start.
Of 200 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 67 months is above that.
Counting every sponsor, half of 226 studies reached it within 29 months; a quarter within 14 and three quarters within 51.
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