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NCT Number: NCT05216666

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

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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Key information

Conditions

Hip Osteoarthritis Arthritis Arthroplasty Complications Atrophy Cardiovascular Diseases Intermittent Claudication Joint Diseases Muscle Atrophy Muscle Injury Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Osteoarthritis Osteoarthritis, Hip Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Rheumatic Diseases Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Mölndal, 431 80, Sweden

Location status: Recruiting

Location contact

Georgios Tsikandylakis, MD, PhD

CONTACT

[email protected]

+46313421000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lateral approach

Procedure

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

Other names: Gammer approach

Posterior Approach

Procedure

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

Other names: Moore approach

Primary outcomes

  1. Trendelenburg sign as binary variable (positive/negative)

    Time frame: At 12 months after intervention

    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.

Secondary outcomes

  1. Dislocation

    Time frame: Within 12 months from intervention

    Incidens of postoperative dislocation

  2. Intraoperative blood loss

    Time frame: Intraoperative

    Bleeding during total hip arthroplasty measured in ml

  3. Periprosthetic infection

    Time frame: Within 12 months from intervention

    Incidens of deep surgical wound infection

  4. Oxford Hip Score

    Time frame: At 3 months after intervention

    Patient-reported hip function measured in a scale of 0-48

  5. Oxford Hip Score

    Time frame: At 12 months after intervention

    Patient-reported hip function measured in a scale of 0-48

  6. Euroqol 5 dimension 5 level index (EQ5D-5L)

    Time frame: At 3 months after intervention

    Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1

  7. Euroqol 5 dimension 5 level index (EQ5D-5L)

    Time frame: At 12 months after intervention

    Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1

  8. Euroqol visual analog scale (EQVAS)

    Time frame: At 3 months after intervention

    Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100

  9. Euroqol visual analog scale (EQVAS)

    Time frame: At 12 months after intervention

    Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100

  10. University of California Activity Level (UCLA)

    Time frame: At 3 months after intervention

    Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10

  11. University of California Activity Level (UCLA)

    Time frame: At 12 months after intervention

    Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10

  12. Gluteus medius avulsion in ultrasound

    Time frame: At 3 months after intervention

    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

  13. Gluteus medius atrophy in Magnetic Resonance Imaging

    Time frame: At 3 months after intervention

    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)

  14. Hip abuction torque

    Time frame: At 3 months after intervention

    Hip abuction torque measured in Nm/Kg with gate analysis

  15. Trendelenburg sign as binary variable (positive/negative)

    Time frame: At 3 months after intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Tsikandylakis, MD PhD

CONTACT

[email protected]

0046313421000

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis

Acronym: HSS

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jan 31, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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