Arthroplasty Complications, Muscle Atrophy, Muscle Tear, Muscle Weakness
Conditions
Keywords
Gluteus medius, Limp, Abductor, Trendelenburg
Brief summary
Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical treatment. Our hypothesis is that surgical treatment followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
Detailed description
Residual limping due to gluteus medius insufficiency after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate surgical reconstruction of gluteus medius using Achilles tendon allograft and compare its results and adverse events with non-surgical treatment. Our hypothesis is that surgical reconstruction followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
Interventions
PROCEDURESurgical reconstruction of gluteus medius with Achilles tendon allograft
Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter
Sponsors
Göteborg University
Vastra Gotaland Region
The Swedish Society of Medicine
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial with the option of crossover in the control group after a certain period of time.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Persisting limping with positive Trendelenburg's sign for at least 12 months after total hip arthroplasty * Rupture/avulsion of the gluteus medius tendon verified with ultrasound or MRI * Leg length discrepancy of less than 1 cm * Femoral offset discrepancy of less than 25%
Exclusion criteria
* Neuromuscular disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip Score (OHS) | 12 months | Patient-reported hip function measured in a scale 0-48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip abduction torque | 12 months | Abduction torque in the frontal plane measured in Nm/Kg with gait analysis |
| University of California Level of Activity (UCLA) | 12 months | Patient-reported activity level measured with in a rank scale 0-10 |
| Trendelenburg's sign | 12 months | Presence or abscence of Trendelenburg's sign as binary outcome (yes/no) |
| Euroqol visual analog scale (EQVAS) | 12 months | Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100 |
| Adverse events | 12 months | All complications resulting in contact with health care provider within one year. |
| Euroqol 5 dimension 5 level index (EQ5D-5L) | 12 months | Patient-reported health-related quality of life measured with swedish version of the euroqol 5 dimension 5 level index in a scale 0-1 |
Countries
Sweden
Outcome results
None listed