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

Muscle Weakness Clinical Trial

— HSS  

Official title:

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216666
• Other study ID #: 277461
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Georgios Tsikandylakis, MD PhD
• Phone: 0046313421000
• Email: tsikandylakis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Osteoarthritis
• Muscle Atrophy
• Muscle Injury
• Muscle Weakness
• Muscular Atrophy
• Osteoarthritis, Hip

Intervention

Procedure:
• Lateral approach
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
• Posterior approach
Total hip arthroplasty performed through a posterior surgical approach (Moore)

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Mölndal

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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