The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty (HSS)

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness; Muscle Atrophy; Hip Osteoarthritis; Arthroplasty Complications; Muscle Injury
• Intervention / Treatment: Procedure: Lateral approach; Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 580
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgios Tsikandylakis, MD PhD; Phone Number: 0046313421000; Email: tsikandylakis@gmail.com

Study Locations

• Sweden
  • Mölndal, Sweden, 431 80
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Georgios Tsikandylakis, MD, PhD; Phone Number: +46313421000; Email: tsikandylakis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lateral approach; 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; Total hip arthroplasty performed through a lateral surgical approach (Gammer); Other Names: Gammer approach
Active Comparator: Posterior 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 posterior surgical approach (Moore); Other Names: Moore approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation	Incidens of postoperative dislocation	Within 12 months from intervention
Intraoperative blood loss	Bleeding during total hip arthroplasty measured in ml	Intraoperative
Periprosthetic infection	Incidens of deep surgical wound infection	Within 12 months from intervention
Oxford Hip Score	Patient-reported hip function measured in a scale of 0-48	At 3 months after intervention
Oxford Hip Score	Patient-reported hip function measured in a scale of 0-48	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	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	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	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	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	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	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	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)	At 3 months after intervention
Hip abuction torque	Hip abuction torque measured in Nm/Kg with gate analysis	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.	At 3 months after intervention

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Georgios Tsikandylakis, MD PhD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Trendelenburg; approach; abductor; limp; gluteus medius
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Osteoarthritis; Muscle Weakness; Muscular Atrophy; Osteoarthritis, Hip
• Other Study ID Numbers: 277461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No