The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateral approach, Posterior approach.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis
Overview
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
- Procedure Lateral approach
Total hip arthroplasty performed through a lateral surgical approach (Gammer) - Procedure Posterior approach
Total hip arthroplasty performed through a posterior surgical approach (Moore)
Primary outcome measures
- Trendelenburg sign as binary variable (positive/negative) [Time frame: At 12 months after intervention]
Secondary outcome measures (12)
- Dislocation [Time frame: Within 12 months from intervention]
- Intraoperative blood loss [Time frame: Intraoperative]
- Periprosthetic infection [Time frame: Within 12 months from intervention]
- Oxford Hip Score [Time frame: At 3 months after intervention]
- Oxford Hip Score [Time frame: At 12 months after intervention]
- Euroqol 5 dimension 5 level index (EQ5D-5L) [Time frame: At 3 months after intervention]
- Euroqol 5 dimension 5 level index (EQ5D-5L) [Time frame: At 12 months after intervention]
- Euroqol visual analog scale (EQVAS) [Time frame: At 3 months after intervention]
- Euroqol visual analog scale (EQVAS) [Time frame: At 12 months after intervention]
- University of California Activity Level (UCLA) [Time frame: At 3 months after intervention]
- University of California Activity Level (UCLA) [Time frame: At 12 months after intervention]
- Gluteus medius avulsion in ultrasound [Time frame: At 3 months after intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Mölndal
Publications
- 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. PMID 23039167
- 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. PMID 28440704
- 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 PMID 31060427
- 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. PMID 30080985
- 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. PMID 31146555
- 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. PMID 22410129
Identifiers
NCT: NCT05216666 · 277461