- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431138
Role of Iliotibial Band Stiffness in Perceived Leg Length Discrepancy After Total Hip Arthroplasty
The Role of Iliotibial Band Stiffness Assessed by Shear-Wave Elastography in Objective and Perceived Leg Length Discrepancy After Total Hip Arthroplasty
Patients undergoing total hip arthroplasty (THA) may experience objective or perceived leg length discrepancy (LLD/PLLD), which can negatively affect gait, pelvic balance, and patient satisfaction.
The iliotibial band (ITB) plays a critical role in lateral thigh tension transmission, and alterations in its stiffness may influence the perception of limb length discrepancy.
Shear-wave elastography (SWE) is a noninvasive ultrasound-based technique that enables quantitative assessment of soft tissue stiffness.
This cross-sectional observational study aims to investigate the relationship between ITB stiffness measured by SWE and both radiographic and perceived leg length discrepancy in adult patients who underwent unilateral primary THA at least 12 months previously.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will include adult patients aged 18-90 years who underwent unilateral primary total hip arthroplasty at least 12 months prior to enrollment.
Patients will undergo clinical evaluation, functional scoring, radiographic assessment, and bilateral ITB stiffness measurement using shear-wave elastography.
Radiographic leg length discrepancy will be assessed using previously obtained pelvis AP and full-leg length radiographs without additional imaging exposure.
Perceived leg length discrepancy will be evaluated using a block test during standing examination.
ITB stiffness will be measured bilaterally at standardized anatomical landmarks using SWE by two experienced radiologists.
The primary aim is to assess correlations between ITB stiffness and radiographic LLD, as well as perceived LLD. Secondary analyses will evaluate whether ITB stiffness predicts PLLD independently of radiographic LLD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06170
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age between 18 and 90 years History of unilateral primary TKA, with no prior revision surgery At least 12 months after surgery and returned to functional weight-bearing No use of walking aids, or use of a cane only for outdoor ambulation
Exclusion Criteria:
Bilateral TKA or severe osteoarthritis in the contralateral hip History of femoral, tibial, or hip surgery resulting in limb length-altering deformity Significant scoliosis (>20° Cobb angle) or pelvic obliquity >5° Neurological disorders (e.g., severe polyneuropathy, hemiparesis) History of lateral thigh surgery (e.g., IT band release, TFL surgery) Body mass index (BMI) >40 (may reduce the reliability of SWE measurements) Suspected prosthetic joint infection or implant instability
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Postoperative Follow-up Cohort
Patients who underwent surgery and were followed as part of routine postoperative care.
Clinical scores and radiographic assessments were recorded during follow-up.
Non-interventional ultrasound evaluation was performed in patients who had completed at least 12 months after surgery; some patients were assessed at longer postoperative intervals.
|
Non-interventional ultrasound performed during routine follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harris Hip Score
Time Frame: At least 12 months postoperatively
|
At least 12 months postoperatively
|
|
|
Oxford Hip Score
Time Frame: At least 12 months postoperatively
|
At least 12 months postoperatively
|
|
|
HOOS score
Time Frame: At least 12 months postoperatively
|
Hip Disability and Osteoarthritis Outcome Score
|
At least 12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
leg length difference
Time Frame: At least 12 months postoperatively
|
At least 12 months postoperatively
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
iliotibial band tension-elastogram
Time Frame: At least 12 months postoperatively
|
At least 12 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK1-2025-581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroplasty, Replacement, Hip
-
Campus Bio-Medico UniversityRecruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
Sunnybrook Health Sciences CentreCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
SCRI Development Innovations, LLCWithdrawnArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Haute Ecole de Santé VaudNot yet recruitingArthroplasty, Replacement, Hip | Arthroplasty Replacement, KneeSwitzerland
-
University of British ColumbiaThe Arthritis Society, Canada; Centre for Aging SMART; Centre for Advancing Health...Not yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University Hospital, Strasbourg, FranceRecruitingArthroplasty, Hip Replacement | Arthroplasty, Knee ReplacementFrance
-
Henry Ford Health SystemConsumer Sleep SolutionsNot yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
The Cleveland ClinicZimmer Biomet; Accelero Health Partners, LLCCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
The Cleveland ClinicStryker OrthopaedicsCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
Clinical Trials on Shear-Wave Elastography (Ultrasound)
-
Assiut UniversityNot yet recruitingParkinson Disease
-
Children's Mercy Hospital Kansas CityCompletedSinusoidal Obstruction Syndrome | Complications of Bone Marrow TransplantUnited States
-
Hospices Civils de LyonCompleted
-
Ozge GungorCompletedMolar Incisor HypomineralizationTurkey
-
First Affiliated Hospital of Wannan Medical CollegeNot yet recruitingCritical Illness Myopathy | Critical Illness Polyneuropathy | ICU-acquired WeaknessChina
-
University of Southern CaliforniaNational Cancer Institute (NCI); L K Whittier FoundationTerminated
-
Groupe Hospitalier du HavreNot yet recruiting
-
Seoul National University HospitalCompleted
-
University of Southern CaliforniaSiemens Medical Solutions USA - CSGTerminated
-
Mayo ClinicCompletedCarotid Artery PlaqueUnited States