Clinical trial NCT05216666: The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty
Official title: Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Muscle Weakness
Muscle Atrophy
Muscle Injury
Arthroplasty Complications
Keywords: abductor
approach
limp
Trendelenburg
gluteus medius
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2022-01-31
Enrollment: 580
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Trendelenburg sign as binary variable (positive/negative)
timeFrame: At 12 months after intervention
Secondary outcomes:
measure: Dislocation
timeFrame: Within 12 months from intervention
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Periprosthetic infection
timeFrame: Within 12 months from intervention
measure: Oxford Hip Score
timeFrame: At 3 months after intervention
measure: Oxford Hip Score
timeFrame: At 12 months after intervention
measure: Euroqol 5 dimension 5 level index (EQ5D-5L)
timeFrame: At 3 months after intervention
measure: Euroqol 5 dimension 5 level index (EQ5D-5L)
timeFrame: At 12 months after intervention
measure: Euroqol visual analog scale (EQVAS)
timeFrame: At 3 months after intervention
measure: Euroqol visual analog scale (EQVAS)
timeFrame: At 12 months after intervention
measure: University of California Activity Level (UCLA)
timeFrame: At 3 months after intervention
measure: University of California Activity Level (UCLA)
timeFrame: At 12 months after intervention
measure: Gluteus medius avulsion in ultrasound
timeFrame: At 3 months after intervention
measure: Gluteus medius atrophy in Magnetic Resonance Imaging
timeFrame: At 3 months after intervention
measure: Hip abuction torque
timeFrame: At 3 months after intervention
measure: Trendelenburg sign as binary variable (positive/negative)
timeFrame: At 3 months after intervention
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Georgios Tsikandylakis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8.
citation: Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25.
citation: Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May 7.
citation: Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.
citation: Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1.
citation: Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10.