Hip OsteoarthritisNCT07186374
Relationship of Radiographic Findings With Pain, Function, Physical Performance and Balance
An observational study of Hip Osteoarthritis, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this investigation was to examine the correlation between radiographic findings and clinical outcomes, including pain, functional ability, physical performance, and balance parameters, in patients diagnosed with hip osteoarthritis (PwHOA). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 31 Dec 2025
- How long will I take part?
- 3 Months
- 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 40 to 79 years
- All sexes
- Adult, Older adult
Study population: Adults diagnosed with hip osteoarthritis will be included in the study.
Who may be able to join
- patients with symptomatic and radiographic diagnosis of Grade I-IV hip osteoarthritis according to the Kellgren-Lawrence classification and American College of Rheumatology criteria.
Who cannot join
- patients who did not give consent to participate in the study;
- secondary HOA due to rheumatoid arthritis, tumors, and recent fractures;
- history of intra-articular injections within the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Radiographic Findings With Pain, Function, Physical Performance and Balance in Patients With Hip Osteoarthritis
The objective of this investigation was to examine the correlation between radiographic findings and clinical outcomes, including pain, functional ability, physical performance, and balance parameters, in patients diagnosed with hip osteoarthritis (PwHOA).
Read the detailed description
A total of seventy-two patients with hip osteoarthritis (PwHOA) will be enrolled in the study. Sociodemographic variables will be collected, and assessments will include the Kellgren-Lawrence Classification, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Timed Up and Go Test (TUG), and Four Square Step Test (FSST). The Spearman rank correlation coefficient will be employed to analyze the relationships among pain levels, functional capacity, physical performance, balance, and radiographic findings.
- Conditions
- Hip Osteoarthritis
- Keywords
- hip, osteoarthritis, function, balance, radiography
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hip Osteoarthritis (PwHOA) | Adults diagnosed with hip osteoarthritis will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren-Lawrence Classification
This assessment, acknowledged by the World Health Organization as the definitive standard for the radiographic classification of osteoarthritis, shall be conducted by a qualified orthopaedic specialist. The evaluation will be based on radiographic imaging obtained in both the sagittal and frontal planes while the patient maintains an upright stance. Utilizing the 0-4 severity grading system, a score of '0' denotes the absence of osteoarthritis, whereas a score of '4' signifies advanced, severe osteoarthritic changes.
Measured: Single assessment at enrollment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
This index, employed for the evaluation of pain, stiffness, and functional impairment, has demonstrated validity and reliability in patients diagnosed with Knee Osteoarthritis (KOA) and Hip Osteoarthritis (HOA), with Intraclass Correlation Coefficients (ICC) ranging from 0.80 to 0.90. It comprises 24 items, each rated on a 5-point Likert scale from 0 to 4, where 0 indicates absence of symptoms, 1 signifies mild symptoms, 2 denotes moderate severity, 3 corresponds to severe symptoms, and 4 reflects extreme severity.
Measured: Single assessment at enrollment
Timed Up and Go Test (TUG)
The procedure will initiate with participants seated upright in a chair with their arms resting on their laps. The time required for each participant to rise from a chair elevated to 45 centimeters, traverse a distance of 3 meters at maximum effort, execute a turnaround, and return to the original chair to sit will be measured in seconds utilizing a stopwatch. Following a preliminary trial, the mean duration from two recorded trials will be calculated for analysis.
Measured: Single assessment at enrollment
Four Square Step Test
The assessment of dynamic balance will be conducted utilizing the four-square step test. The test environment will be delineated by arranging bars, each measuring 90 cm in length, in a '+' configuration. The squares will be sequentially numbered clockwise from 1 to 4, commencing with the bottom left square. Participants will be instructed to traverse the squares following the sequence: 2 → 3 → 4 → 1 → 4 → 3 → 2 → 1. The time required to complete the sequence will be measured in seconds using a stopwatch. Following an initial practice trial, the average of two recorded trials will be calculated for analysis.
Measured: Single assessment at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start20 Sep 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yıldız Kızkın, Artvin Coruh University
- Investigators
- Zeynep Yıldız Kızkın, Dr., Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186374
- Sponsor's protocol ID
- Hip Osteoarthritis
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson AE, Hu D, Arbeeva L, Alvarez C, Cleveland RJ, Schwartz TA, Murphy LB, Helmick CG, Callahan LF, Renner JB, Jordan JM, Golightly YM. Point prevalence of Hip Symptoms, Radiographic, And Symptomatic OA at Five Time Points: The Johnston County Osteoarthritis Project, 1991-2018. Osteoarthr Cartil Open. 2022 Jun;4(2):100251. doi: 10.1016/j.ocarto.2022.100251. Epub 2022 Mar 15.
PubMed 36118130Turkiewicz A, Kiadaliri AA, Englund M. Cause-specific mortality in osteoarthritis of peripheral joints. Osteoarthritis Cartilage. 2019 Jun;27(6):848-854. doi: 10.1016/j.joca.2019.02.793. Epub 2019 Feb 21.
PubMed 30797945Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
PubMed 33560326Ritsuno Y, Morita M, Mukaino M, Otsuka K, Kanaji A, Yamada J, Saitoh E, Matsumoto M, Nakamura M, Otaka Y, Fujita N. Determinants of Gait Parameters in Patients With Severe Hip Osteoarthritis. Arch Phys Med Rehabil. 2024 Feb;105(2):343-351. doi: 10.1016/j.apmr.2023.08.021. Epub 2023 Sep 7.
PubMed 37683907Ozden F, Nadiye Karaman O, Tugay N, Yalin Kilinc C, Mihriban Kilinc R, Umut Tugay B. The relationship of radiographic findings with pain, function, and quality of life in patients with knee osteoarthritis. J Clin Orthop Trauma. 2020 Jul;11(Suppl 4):S512-S517. doi: 10.1016/j.jcot.2020.04.006. Epub 2020 Apr 9.
PubMed 32774020Jacobsen S. Adult hip dysplasia and osteoarthritis. Studies in radiology and clinical epidemiology. Acta Orthop Suppl. 2006 Dec;77(324):1-37.
PubMed 17380595Riddle DL, Perera RA. American Academy of Orthopedic Surgeons Appropriate Use Criteria for Hip Preservation Surgery: Variables That Drive Appropriateness for Surgery. Arthritis Care Res (Hoboken). 2020 Mar;72(3):405-411. doi: 10.1002/acr.23828.
PubMed 30675763Hattori T, Shimo K, Niwa Y, Tokiwa Y, Matsubara T. Association of Chronic Pain with Radiologic Severity and Central Sensitization in Hip Osteoarthritis Patients. J Pain Res. 2021 Apr 22;14:1153-1160. doi: 10.2147/JPR.S296273. eCollection 2021.
PubMed 33911897Rondas GA, Macri EM, Oei EH, Bierma-Zeinstra SM, Rijkels-Otters HB, Runhaar J. Association between hip pain and radiographic hip osteoarthritis in primary care: the CHECK cohort. Br J Gen Pract. 2022 Jul 26;72(723):e722-8. doi: 10.3399/BJGP.2021.0547. Online ahead of print.
PubMed 36127152Pereira D, Severo M, Santos RA, Barros H, Branco J, Lucas R, Costa L, Ramos E. Knee and hip radiographic osteoarthritis features: differences on pain, function and quality of life. Clin Rheumatol. 2016 Jun;35(6):1555-64. doi: 10.1007/s10067-015-3087-7. Epub 2015 Oct 7.
PubMed 26445941Cubukcu D, Sarsan A, Alkan H. Relationships between Pain, Function and Radiographic Findings in Osteoarthritis of the Knee: A Cross-Sectional Study. Arthritis. 2012;2012:984060. doi: 10.1155/2012/984060. Epub 2012 Nov 19.
PubMed 23209900Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Iidaka T, Horii C, Muraki S, Oka H, Kawaguchi H, Nakamura K, Akune T, Tanaka S, Yoshimura N. Trends in prevalence of hip osteoarthritis over a 10-year period in Japan: The ROAD study 2005-2015. Osteoarthr Cartil Open. 2022 Jun 22;4(3):100285. doi: 10.1016/j.ocarto.2022.100285. eCollection 2022 Sep.
PubMed 36474937Batting M, Barker KL. Reliability and validity of the Four Square Step Test in patients with hip osteoarthritis before and after total hip replacement. Physiotherapy. 2019 Jun;105(2):244-253. doi: 10.1016/j.physio.2018.07.014. Epub 2018 Oct 15.
PubMed 30630621Canzone A, Roggio F, Patti A, Giustino V, Mannucci C, Di Mauro D, Musumeci G, Bianco A, Trimarchi F. Classification of Physical Activity Programs Based on the Kellgren & Lawrence Scale for Knee Osteoarthritis: A Systematic Review. Musculoskeletal Care. 2024 Dec;22(4):e70019. doi: 10.1002/msc.70019.
PubMed 39592397
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Radiographic Findings With Pain, Function, Physical Performance and Balance in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT07186374
- Acronym / sponsor ID
- Hip Osteoarthritis
- Conditions
- Hip Osteoarthritis
- Keywords
- hip, osteoarthritis, function, balance, radiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Sep 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.
The objective of this investigation was to examine the correlation between radiographic findings and clinical outcomes, including pain, functional ability, physical performance, and balance parameters, in patients diagnosed with hip osteoarthritis (PwHOA).
Detailed description
A total of seventy-two patients with hip osteoarthritis (PwHOA) will be enrolled in the study. Sociodemographic variables will be collected, and assessments will include the Kellgren-Lawrence Classification, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Timed Up and Go Test (TUG), and Four Square Step Test (FSST). The Spearman rank correlation coefficient will be employed to analyze the relationships among pain levels, functional capacity, physical performance, balance, and radiographic findings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hip Osteoarthritis (PwHOA) | – | –Adults diagnosed with hip osteoarthritis will be included in the study. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with hip osteoarthritis will be included in the study.
Key inclusion criteria (1 listed)
- patients with symptomatic and radiographic diagnosis of Grade I-IV hip osteoarthritis according to the Kellgren-Lawrence classification and American College of Rheumatology criteria.
Key exclusion criteria (3 listed)
- patients who did not give consent to participate in the study;
- secondary HOA due to rheumatoid arthritis, tumors, and recent fractures;
- history of intra-articular injections within the last six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kellgren-Lawrence Classification
Time frame: Single assessment at enrollment
This assessment, acknowledged by the World Health Organization as the definitive standard for the radiographic classification of osteoarthritis, shall be conducted by a qualified orthopaedic specialist. The evaluation will be based on radiographic imaging obtained in both the sagittal and frontal planes while the patient maintains an upright stance. Utilizing the 0-4 severity grading system, a score of '0' denotes the absence of osteoarthritis, whereas a score of '4' signifies advanced, severe osteoarthritic changes.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Single assessment at enrollment
This index, employed for the evaluation of pain, stiffness, and functional impairment, has demonstrated validity and reliability in patients diagnosed with Knee Osteoarthritis (KOA) and Hip Osteoarthritis (HOA), with Intraclass Correlation Coefficients (ICC) ranging from 0.80 to 0.90. It comprises 24 items, each rated on a 5-point Likert scale from 0 to 4, where 0 indicates absence of symptoms, 1 signifies mild symptoms, 2 denotes moderate severity, 3 corresponds to severe symptoms, and 4 reflects extreme severity.
Timed Up and Go Test (TUG)
Time frame: Single assessment at enrollment
The procedure will initiate with participants seated upright in a chair with their arms resting on their laps. The time required for each participant to rise from a chair elevated to 45 centimeters, traverse a distance of 3 meters at maximum effort, execute a turnaround, and return to the original chair to sit will be measured in seconds utilizing a stopwatch. Following a preliminary trial, the mean duration from two recorded trials will be calculated for analysis.
Four Square Step Test
Time frame: Single assessment at enrollment
The assessment of dynamic balance will be conducted utilizing the four-square step test. The test environment will be delineated by arranging bars, each measuring 90 cm in length, in a '+' configuration. The squares will be sequentially numbered clockwise from 1 to 4, commencing with the bottom left square. Participants will be instructed to traverse the squares following the sequence: 2 → 3 → 4 → 1 → 4 → 3 → 2 → 1. The time required to complete the sequence will be measured in seconds using a stopwatch. Following an initial practice trial, the average of two recorded trials will be calculated for analysis.
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 17 Mar 2026.
- Background: PubMed 36118130Nelson AE, Hu D, Arbeeva L, Alvarez C, Cleveland RJ, Schwartz TA, Murphy LB, Helmick CG, Callahan LF, Renner JB, Jordan JM, Golightly YM. Point prevalence of Hip Symptoms, Radiographic, And Symptomatic OA at Five Time Points: The Johnston County Osteoarthritis Project, 1991-2018. Osteoarthr Cartil Open. 2022 Jun;4(2):100251. doi: 10.1016/j.ocarto.2022.100251. Epub 2022 Mar 15.
- Background: PubMed 30797945Turkiewicz A, Kiadaliri AA, Englund M. Cause-specific mortality in osteoarthritis of peripheral joints. Osteoarthritis Cartilage. 2019 Jun;27(6):848-854. doi: 10.1016/j.joca.2019.02.793. Epub 2019 Feb 21.
- Background: PubMed 33560326Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
- Background: PubMed 37683907Ritsuno Y, Morita M, Mukaino M, Otsuka K, Kanaji A, Yamada J, Saitoh E, Matsumoto M, Nakamura M, Otaka Y, Fujita N. Determinants of Gait Parameters in Patients With Severe Hip Osteoarthritis. Arch Phys Med Rehabil. 2024 Feb;105(2):343-351. doi: 10.1016/j.apmr.2023.08.021. Epub 2023 Sep 7.
- Background: PubMed 32774020Ozden F, Nadiye Karaman O, Tugay N, Yalin Kilinc C, Mihriban Kilinc R, Umut Tugay B. The relationship of radiographic findings with pain, function, and quality of life in patients with knee osteoarthritis. J Clin Orthop Trauma. 2020 Jul;11(Suppl 4):S512-S517. doi: 10.1016/j.jcot.2020.04.006. Epub 2020 Apr 9.
- Background: PubMed 17380595Jacobsen S. Adult hip dysplasia and osteoarthritis. Studies in radiology and clinical epidemiology. Acta Orthop Suppl. 2006 Dec;77(324):1-37.
- Background: PubMed 30675763Riddle DL, Perera RA. American Academy of Orthopedic Surgeons Appropriate Use Criteria for Hip Preservation Surgery: Variables That Drive Appropriateness for Surgery. Arthritis Care Res (Hoboken). 2020 Mar;72(3):405-411. doi: 10.1002/acr.23828.
- Background: PubMed 33911897Hattori T, Shimo K, Niwa Y, Tokiwa Y, Matsubara T. Association of Chronic Pain with Radiologic Severity and Central Sensitization in Hip Osteoarthritis Patients. J Pain Res. 2021 Apr 22;14:1153-1160. doi: 10.2147/JPR.S296273. eCollection 2021.
- Background: PubMed 36127152Rondas GA, Macri EM, Oei EH, Bierma-Zeinstra SM, Rijkels-Otters HB, Runhaar J. Association between hip pain and radiographic hip osteoarthritis in primary care: the CHECK cohort. Br J Gen Pract. 2022 Jul 26;72(723):e722-8. doi: 10.3399/BJGP.2021.0547. Online ahead of print.
- Background: PubMed 26445941Pereira D, Severo M, Santos RA, Barros H, Branco J, Lucas R, Costa L, Ramos E. Knee and hip radiographic osteoarthritis features: differences on pain, function and quality of life. Clin Rheumatol. 2016 Jun;35(6):1555-64. doi: 10.1007/s10067-015-3087-7. Epub 2015 Oct 7.
- Background: PubMed 23209900Cubukcu D, Sarsan A, Alkan H. Relationships between Pain, Function and Radiographic Findings in Osteoarthritis of the Knee: A Cross-Sectional Study. Arthritis. 2012;2012:984060. doi: 10.1155/2012/984060. Epub 2012 Nov 19.
- Background: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- 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.
Zeynep Yıldız Kızkın, Dr. principal investigator
Artvin Coruh 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 Hip Osteoarthritis, run by Artvin Coruh 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 1 inclusion and 3 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 17 Mar 2026. 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?
Kellgren-Lawrence Classification (time frame: Single assessment at enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07186374, which also lists 17 linked publications.
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 17 Mar 2026.