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Clinical Trials/NCT05216666
NCT05216666
Recruiting
Not Applicable

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

Sahlgrenska University Hospital1 site in 1 country580 target enrollmentMay 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Sahlgrenska University Hospital
Enrollment
580
Locations
1
Primary Endpoint
Trendelenburg sign as binary variable (positive/negative)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2022
End Date
December 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Georgios Tsikandylakis, MD PhD

Senior consultant in orthopaedic surgery

Sahlgrenska University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Trendelenburg sign as binary variable (positive/negative)

Time Frame: 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 Outcomes

  • Dislocation(Within 12 months from intervention)
  • Gluteus medius avulsion in ultrasound(At 3 months after intervention)
  • Euroqol 5 dimension 5 level index (EQ5D-5L)(At 12 months after intervention)
  • Euroqol visual analog scale (EQVAS)(At 12 months after intervention)
  • University of California Activity Level (UCLA)(At 12 months after intervention)
  • Hip abuction torque(At 3 months after intervention)
  • Trendelenburg sign as binary variable (positive/negative)(At 3 months after intervention)
  • Intraoperative blood loss(Intraoperative)
  • Periprosthetic infection(Within 12 months from intervention)
  • Oxford Hip Score(At 12 months after intervention)
  • Gluteus medius atrophy in Magnetic Resonance Imaging(At 3 months after intervention)

Study Sites (1)

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