Total Hip ReplacementNCT07048041
Patient Scores and Functional Tests After Hip Surgery
An observational study of Total Hip Replacement and Patient-Reported Outcomes, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore how well patient self-assessments reflect their actual physical performance following hip replacement surgery. By comparing questionnaire-based scores with practical mobility tests, the study seeks to provide insight into the usefulness of both tools in evaluating recovery after total hip… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Total Hip Replacement, Patient-Reported Outcomes
- What is being tested?
- Functional Assessment Battery
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Sep 2025
- How long will I take part?
- 1 Day
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 55 years and older who underwent unilateral primary total hip arthroplasty at least six months prior. All participants were able to walk independently and had sufficient cognitive and communication abilities to complete physical and questionnaire-based assessments.
Who may be able to join
- Underwent unilateral primary total hip arthroplasty at least 6 months prior
- Ability to walk independently (with or without assistive device)
- Ability to understand and complete assessments and questionnaires
Who cannot join
- Revision or bilateral total hip arthroplasty
- Additional lower extremity surgery after the index THA
- Body mass index (BMI) greater than 40 kg/m²
- Neurological, orthopedic, or systemic disorders affecting gait or balance
- Severe cognitive impairment or communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Patient-Reported Outcomes and Functional Tests After Hip Replacement Surgery
This study aims to explore how well patient self-assessments reflect their actual physical performance following hip replacement surgery. By comparing questionnaire-based scores with practical mobility tests, the study seeks to provide insight into the usefulness of both tools in evaluating recovery after total hip arthroplasty.
Read the detailed description
Hip replacement surgery is generally effective in reducing pain and restoring movement in patients with hip joint problems. Despite the success of the procedure, some individuals continue to report dissatisfaction due to lingering discomfort or limitations in daily activities. A potential reason for this is the gap between how patients perceive their recovery and their actual physical function.
To better understand this issue, the study evaluates two types of assessment tools. The first group includes patient-reported outcome measures (PROMs), which rely on individuals' personal impressions of their symptoms and abilities. The second group involves physical performance tests that measure mobility and balance under clinical supervision.
Fifty patients who had hip replacement surgery at least six months earlier will take part in the study. Each participant will complete standardized questionnaires and undergo a series of physical tests during one clinic visit. The relationship between the two types of assessments will be analyzed using correlation and regression methods.
This research may help improve follow-up care by identifying whether patient questionnaires alone are sufficient to monitor recovery, or if performance-based tests should also be routinely included in rehabilitation planning.
- Conditions
- Total Hip Replacement, Patient-Reported Outcomes
- Being tested
- Functional Assessment Battery
- Keywords
- Total Hip Arthroplasty, Patient-Reported Outcomes, Physical Performance Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Assessment BatteryOther
Also called Timed Up and Go, Four Square Step Test, Gait Speed Test, Oxford Hip Score
Participants completed a series of validated patient-reported outcome questionnaires (Oxford Hip Score, WOMAC, SF-12) and physical performance tests (Timed Up and Go, Four Square Step Test, 4-Meter Gait Speed Test) during a single outpatient assessment session. No therapeutic or invasive interventions were performed.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty (THA) patients | Patients who underwent primary unilateral total hip arthroplasty at least 6 months prior and met all inclusion criteria. Participants were evaluated using patient-reported outcome measures and performance-based physical tests in a single session. Receives: Other: Functional Assessment Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results
The study will assess the strength and direction of the relationship between patient-reported outcomes (Oxford Hip Score, WOMAC, SF-12) and physical performance test results (Timed Up and Go, Four Square Step Test, 4-Meter Gait Speed Test) using correlation coefficients.
Measured: Day of assessment (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025
- Primary completion15 Aug 2025
- Study completion1 Sep 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048041
- Sponsor's protocol ID
- ODU-SBFTR-AYGUNPOLAT-006
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 5 Sep 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient-Reported Outcomes and Functional Tests After Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT07048041
- Acronym / sponsor ID
- ODU-SBFTR-AYGUNPOLAT-006
- Conditions
- Total Hip Replacement, Patient-Reported Outcomes
- Keywords
- Total Hip Arthroplasty, Patient-Reported Outcomes, Physical Performance Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 2 Jul 2025 (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.
This study aims to explore how well patient self-assessments reflect their actual physical performance following hip replacement surgery. By comparing questionnaire-based scores with practical mobility tests, the study seeks to provide insight into the usefulness of both tools in evaluating recovery after total hip arthroplasty.
Detailed description
Hip replacement surgery is generally effective in reducing pain and restoring movement in patients with hip joint problems. Despite the success of the procedure, some individuals continue to report dissatisfaction due to lingering discomfort or limitations in daily activities. A potential reason for this is the gap between how patients perceive their recovery and their actual physical function.
To better understand this issue, the study evaluates two types of assessment tools. The first group includes patient-reported outcome measures (PROMs), which rely on individuals' personal impressions of their symptoms and abilities. The second group involves physical performance tests that measure mobility and balance under clinical supervision.
Fifty patients who had hip replacement surgery at least six months earlier will take part in the study. Each participant will complete standardized questionnaires and undergo a series of physical tests during one clinic visit. The relationship between the two types of assessments will be analyzed using correlation and regression methods.
This research may help improve follow-up care by identifying whether patient questionnaires alone are sufficient to monitor recovery, or if performance-based tests should also be routinely included in rehabilitation planning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty (THA) patients | – | Other: Functional Assessment BatteryPatients who underwent primary unilateral total hip arthroplasty at least 6 months prior and met all inclusion criteria. Participants were evaluated using patient-reported outcome measures and performance-based physical tests in a single session. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 55 years and older who underwent unilateral primary total hip arthroplasty at least six months prior. All participants were able to walk independently and had sufficient cognitive and communication abilities to complete physical and questionnaire-based assessments.
Key inclusion criteria (3 listed)
- Underwent unilateral primary total hip arthroplasty at least 6 months prior
- Ability to walk independently (with or without assistive device)
- Ability to understand and complete assessments and questionnaires
Key exclusion criteria (5 listed)
- Revision or bilateral total hip arthroplasty
- Additional lower extremity surgery after the index THA
- Body mass index (BMI) greater than 40 kg/m²
- Neurological, orthopedic, or systemic disorders affecting gait or balance
- Severe cognitive impairment or communication difficulties
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 Assessment BatteryAlso: Timed Up and Go, Four Square Step Test, Gait Speed Test, Oxford Hip ScoreParticipants completed a series of validated patient-reported outcome questionnaires (Oxford Hip Score, WOMAC, SF-12) and physical performance tests (Timed Up and Go, Four Square Step Test, 4-Meter Gait Speed Test) during a single outpatient assessment session. No therapeutic or invasive interventions were performed. | Other | Total Hip Arthroplasty (THA) patients |
Primary outcome
Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results
Time frame: Day of assessment (single visit)
The study will assess the strength and direction of the relationship between patient-reported outcomes (Oxford Hip Score, WOMAC, SF-12) and physical performance test results (Timed Up and Go, Four Square Step Test, 4-Meter Gait Speed Test) using correlation coefficients.
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 5 Sep 2025.
- Individual participant dataSharing planned: No
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Developmental Dysplasia of the Hip, Acetabular Bone Loss
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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
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 Patient-Reported Outcomes, 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 3 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 5 Sep 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?
Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results Correlation Between PROM Scores and Performance-Based Test Results (time frame: Day of assessment (single visit)). 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 5 Sep 2025.