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

NCT05216666 | Recruiting

• 1 other identifier: 277461
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Muscle Weakness; Muscle Atrophy; Muscle Injury; Arthroplasty Complications

Keywords

abductor; approach; limp; Trendelenburg; gluteus medius

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Dislocation

  Within 12 months from intervention

• Intraoperative blood loss

  Intraoperative

• Periprosthetic infection

  Within 12 months from intervention

• Oxford Hip Score

  At 3 months after intervention

• Oxford Hip Score

  At 12 months after intervention

Study Arms (2)

Lateral approach

ACTIVE COMPARATOR

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

Posterior approach

ACTIVE COMPARATOR

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

Interventions

Lateral approach PROCEDURE

Total hip arthroplasty performed through a lateral surgical approach (Gammer)

Also known as: Gammer approach

Lateral approach

Posterior approach PROCEDURE

Total hip arthroplasty performed through a posterior surgical approach (Moore)

Also known as: Moore approach

Posterior approach

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
• Ability to understand and write swedish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, 431 80, Sweden

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31060427 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Muscle Weakness; Muscular Atrophy; Intermittent Claudication

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Georgios Tsikandylakis, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Tsikandylakis, MD PhD

CONTACT

0046313421000; tsikandylakis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant in orthopaedic surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: January 31, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)