- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711042
How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty (THA)
The Effect of Spinopelvic Movements on Hip Functions in Patients With Total Hip Arthroplasty
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ordu, Turkey
- Ordu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will include patients who underwent primary total hip arthroplasty using the posterolateral approach by the same surgeon at Ordu University Training and Research Hospital, Department of Orthopedics and Traumatology, during the years 2022-2023. Eligible patients must be aged 60 years or older and have a minimum of 12 months post-surgery.
Exclusion criteria include patients with modular neck implants, metal-metal, or ceramic bearing surfaces, hip infections, advanced osteoarthritis in the contralateral hip, leg length discrepancy, neurological, orthopedic, or systemic diseases affecting gait or balance, or a body mass index (BMI) greater than 40 kg/m².
Description
Inclusion Criteria:
- Patients aged 60 and older.
- At least 12 months post-surgery.
Exclusion Criteria:
- Patients with modular neck implants, metal-metal, or ceramic bearing surfaces.
- Patients with hip infection or advanced osteoarthritis in the contralateral hip.
- Patients with leg length discrepancy.
- Patients with neurological, orthopedic, or systemic diseases affecting gait or balance.
- Patients with a body mass index (BMI) greater than 40 kg/m².
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group (Implant Placement Within Functional Safe Zone - FSZ)
This group will consist of patients who have previously undergone total hip arthroplasty (TKA) with implant placement within the functional safe zone (FSZ).
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In this observational study, no active interventions or treatments will be administered to the participants.
Both groups (Control Group and Experimental Group) will undergo clinical evaluations, including functional tests (WOMAC, Harris Hip Score, Oxford Hip Score, SF-12, TUG) and radiographic analysis (angular measurements).
The participants' outcomes will be compared based on their implant placement (within or outside the Functional Safe Zone).
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Experimental Group (Implant Placement Outside Functional Safe Zone - FSZ)
This group will consist of patients who have previously undergone total hip arthroplasty (TKA) but have implant placement outside the functional safe zone (FSZ).
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In this observational study, no active interventions or treatments will be administered to the participants.
Both groups (Control Group and Experimental Group) will undergo clinical evaluations, including functional tests (WOMAC, Harris Hip Score, Oxford Hip Score, SF-12, TUG) and radiographic analysis (angular measurements).
The participants' outcomes will be compared based on their implant placement (within or outside the Functional Safe Zone).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiographic Angular Measurements
Time Frame: At least 12 months after surgery
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The angular measurements of the implant positions will be assessed using pre-existing routine control radiographs.
This includes analysis of the pelvic tilt, acetabular anteversion, and femoral anteversion, which will be measured by two experienced radiologists using the General Electric Centricity PACS system.
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At least 12 months after surgery
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WOMAC (Western Ontario and McMaster Osteoarthritis Index)
Time Frame: At least 12 months after surgery
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The WOMAC score will be used to assess pain, stiffness, and physical function in patients with hip osteoarthritis.
It includes 24 questions across three domains: pain, stiffness, and physical function
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At least 12 months after surgery
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Harris Hip Score (HHS)
Time Frame: At least 12 months after surgery
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The Harris Hip Score will be used to assess the hip function and pain level in patients who have undergone total hip arthroplasty.
It consists of several domains, including pain, function, range of motion, and deformity.
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At least 12 months after surgery
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Oxford Hip Score
Time Frame: At least 12 months after surgery
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The Oxford Hip Score will be used to assess hip function and the impact of hip arthritis on patients' quality of life.
It includes questions on pain and function during daily activities.
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At least 12 months after surgery
|
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SF-12 (Short Form-12 Health Survey)
Time Frame: At least 12 months after surgery
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The SF-12 is a 12-item questionnaire used to assess the overall health-related quality of life.
It includes physical and mental health components and provides a summary score for each.
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At least 12 months after surgery
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TUG (Timed Up and Go) Test
Time Frame: At least 12 months after surgery
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The Timed Up and Go (TUG) test is a functional assessment to evaluate mobility, balance, and risk of falls.
The patient is asked to rise from a seated position, walk 3 meters, turn around, walk back, and sit down again.
The total time taken to complete the task is measured in seconds.
It is useful in assessing recovery progress and mobility after total hip arthroplasty (THA).
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At least 12 months after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elif AYGUN POLAT, PhD, T.C. ORDU ÜNİVERSİTESİ
- Study Chair: Alper ÇIRAKLI, Prof., T.C. ORDU ÜNİVERSİTESİ
- Study Director: Yusuf POLAT, Assoc.Prof., T.C. ORDU ÜNİVERSİTESİ
- Principal Investigator: Murat ALPARSLAN, MD, T.C. ORDU ÜNİVERSİTESİ
- Principal Investigator: Tolga KECECİ, Assoc.Prof., T.C. ORDU ÜNİVERSİTESİ
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
- ODU-SBFTR-AYGUNPOLAT-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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