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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hip Osteoarthritis Muscle Weakness Muscle Atrophy Muscle Injury Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lateral approach

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Posterior approach

Intervention Type PROCEDURE

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

Interventions

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Lateral approach

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

Intervention Type PROCEDURE

Posterior approach

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

Intervention Type PROCEDURE

Other Intervention Names

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Gammer approach Moore approach

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No