Total Hip ReplacementTHANCT06711042
How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty
An observational study of Total Hip Replacement and Hip Dislocation, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Our study aims to evaluate the effect of spinopelvic movement on hip functions in individuals who have undergone total hip arthroplasty (THA). This study will contribute to the literature by helping identify and prevent issues experienced by THA patients, ranging from hip pain to limited mobility and even hip… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Hip Replacement, Hip Dislocation, Hip Osteoarthritis
- What is being tested?
- functional tests and radiographic analysis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 60 and older.
- At least 12 months post-surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Spinopelvic Movements on Hip Functions in Patients With Total Hip Arthroplasty
Our study aims to evaluate the effect of spinopelvic movement on hip functions in individuals who have undergone total hip arthroplasty (THA). This study will contribute to the literature by helping identify and prevent issues experienced by THA patients, ranging from hip pain to limited mobility and even hip dislocation.
Read the detailed description
Total hip arthroplasty (THA) is a widely accepted surgical procedure that effectively alleviates pain, enhances mobility, and improves physical function in patients with hip osteoarthritis. However, improper placement of implants during surgery can lead to complications such as abnormal edge loading, early wear of polyethylene components, ceramic insert fractures, or hip dislocations, often requiring early revision surgeries. While Lewinnek's "safe zone" (30°-50° inclination and 5°-25° anteversion for the acetabular component) has traditionally been used as a guideline, recent studies have reported significant dislocation rates even within these parameters, highlighting spinopelvic movement abnormalities as a critical factor. Normal spinopelvic-hip mechanics allow for adaptive changes in the pelvis and acetabulum during positional transitions, thereby preventing anterior or posterior impingement in the hip joint. However, patients with restricted lumbosacral mobility are at a greater risk of impingement-related symptoms. To address these challenges, advanced metrics such as sacral slope difference (ΔSS), pelvic-femoral angle (PFA), and combined sagittal index (CSI) have been introduced to better define functional safe zones and assess risks of hip impingement and dislocation. While the relationship between CSI and hip dislocations is established, its impact on hip function remains unclear. This study aims to evaluate the effect of spinopelvic movement on hip function in individuals who have undergone THA. By identifying and preventing complications such as hip pain, mobility restrictions, and dislocations, the research seeks to provide meaningful contributions to the literature and improve patient outcomes.
- Conditions
- Total Hip Replacement, Hip Dislocation, Hip Osteoarthritis
- Being tested
- functional tests and radiographic analysis
- Medical subject headings
- Hip Dislocation, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional tests and radiographic analysisDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: functional tests and radiographic analysis | |
| 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). Receives: Diagnostic Test: functional tests and radiographic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Angular Measurements
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.
Measured: At least 12 months after surgery
WOMAC (Western Ontario and McMaster Osteoarthritis Index)
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
Measured: At least 12 months after surgery
Harris Hip Score (HHS)
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.
Measured: At least 12 months after surgery
Oxford Hip Score
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.
Measured: At least 12 months after surgery
SF-12 (Short Form-12 Health Survey)
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.
Measured: At least 12 months after surgery
TUG (Timed Up and Go) Test
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).
Measured: At least 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024
- Primary completion12 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif AYGUN POLAT, Ordu University
- Investigators
- Yusuf POLAT, Assoc.Prof., Study director, Ordu UniversityElif AYGUN POLAT, PhD, Principal investigator, Ordu UniversityMurat ALPARSLAN, MD, Principal investigator, Ordu UniversityTolga KECECİ, Assoc.Prof., Principal investigator, Ordu UniversityAlper ÇIRAKLI, Prof., Study chair, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711042
- Sponsor's protocol ID
- ODU-SBFTR-AYGUNPOLAT-004
- Acronym
- THA
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinopelvic Movements on Hip Functions in Patients With Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06711042
- Acronym / sponsor ID
- THA / ODU-SBFTR-AYGUNPOLAT-004
- Conditions
- Total Hip Replacement, Hip Dislocation, Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to evaluate the effect of spinopelvic movement on hip functions in individuals who have undergone total hip arthroplasty (THA). This study will contribute to the literature by helping identify and prevent issues experienced by THA patients, ranging from hip pain to limited mobility and even hip dislocation.
Detailed description
Total hip arthroplasty (THA) is a widely accepted surgical procedure that effectively alleviates pain, enhances mobility, and improves physical function in patients with hip osteoarthritis. However, improper placement of implants during surgery can lead to complications such as abnormal edge loading, early wear of polyethylene components, ceramic insert fractures, or hip dislocations, often requiring early revision surgeries. While Lewinnek's "safe zone" (30°-50° inclination and 5°-25° anteversion for the acetabular component) has traditionally been used as a guideline, recent studies have reported significant dislocation rates even within these parameters, highlighting spinopelvic movement abnormalities as a critical factor. Normal spinopelvic-hip mechanics allow for adaptive changes in the pelvis and acetabulum during positional transitions, thereby preventing anterior or posterior impingement in the hip joint. However, patients with restricted lumbosacral mobility are at a greater risk of impingement-related symptoms. To address these challenges, advanced metrics such as sacral slope difference (ΔSS), pelvic-femoral angle (PFA), and combined sagittal index (CSI) have been introduced to better define functional safe zones and assess risks of hip impingement and dislocation. While the relationship between CSI and hip dislocations is established, its impact on hip function remains unclear. This study aims to evaluate the effect of spinopelvic movement on hip function in individuals who have undergone THA. By identifying and preventing complications such as hip pain, mobility restrictions, and dislocations, the research seeks to provide meaningful contributions to the literature and improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Implant Placement Within Functional Safe Zone - FSZ) | – | Diagnostic Test: functional tests and radiographic analysisThis group will consist of patients who have previously undergone total hip arthroplasty (TKA) with implant placement within the functional safe zone (FSZ). |
| Experimental Group (Implant Placement Outside Functional Safe Zone - FSZ) | – | Diagnostic Test: functional tests and radiographic analysisThis group will consist of patients who have previously undergone total hip arthroplasty (TKA) but have implant placement outside the functional safe zone (FSZ). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 60 and older.
- At least 12 months post-surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional tests and radiographic analysisIn 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). | Diagnostic test | Control Group (Implant Placement Within Functional Safe Zone - FSZ), Experimental Group (Implant Placement Outside Functional Safe Zone - FSZ) |
Primary outcome
Radiographic Angular Measurements
Time frame: At least 12 months after surgery
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.
WOMAC (Western Ontario and McMaster Osteoarthritis Index)
Time frame: At least 12 months after surgery
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
Harris Hip Score (HHS)
Time frame: At least 12 months after surgery
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.
Oxford Hip Score
Time frame: At least 12 months after surgery
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.
SF-12 (Short Form-12 Health Survey)
Time frame: At least 12 months after surgery
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.
TUG (Timed Up and Go) Test
Time frame: At least 12 months after surgery
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf POLAT, Assoc.Prof. study director
Ordu University
Elif AYGUN POLAT, PhD principal investigator
Ordu University
Murat ALPARSLAN, MD principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement and Hip Dislocation, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Angular Measurements (time frame: At least 12 months after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.