NCT07186374

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

September 15, 2025

Last Update Submit

March 14, 2026

Conditions

Keywords

hiposteoarthritisfunctionbalanceradiography

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Single assessment at enrollment

Study Arms (1)

Patients with Hip Osteoarthritis (PwHOA)

Adults diagnosed with hip osteoarthritis will be included in the study.

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults diagnosed with hip osteoarthritis will be included in the study.

You may qualify if:

  • patients with symptomatic and radiographic diagnosis of Grade I-IV hip osteoarthritis according to the Kellgren-Lawrence classification and American College of Rheumatology criteria.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Yıldız Kızkın

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (17)

  • 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.

    PMID: 36118130BACKGROUND
  • Turkiewicz 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.

    PMID: 30797945BACKGROUND
  • Katz 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.

    PMID: 33560326BACKGROUND
  • Ritsuno 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.

    PMID: 37683907BACKGROUND
  • Ozden 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.

    PMID: 32774020BACKGROUND
  • Jacobsen S. Adult hip dysplasia and osteoarthritis. Studies in radiology and clinical epidemiology. Acta Orthop Suppl. 2006 Dec;77(324):1-37.

    PMID: 17380595BACKGROUND
  • Riddle 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.

    PMID: 30675763BACKGROUND
  • Hattori 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.

    PMID: 33911897BACKGROUND
  • Rondas 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.

    PMID: 36127152BACKGROUND
  • Pereira 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.

    PMID: 26445941BACKGROUND
  • Cubukcu 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.

    PMID: 23209900BACKGROUND
  • Altman 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.

    PMID: 3741515BACKGROUND
  • Iidaka 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.

    PMID: 36474937BACKGROUND
  • Batting 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.

    PMID: 30630621BACKGROUND
  • Canzone 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.

    PMID: 39592397BACKGROUND
  • Thumboo J, Chew LH, Soh CH. Validation of the Western Ontario and Mcmaster University osteoarthritis index in Asians with osteoarthritis in Singapore. Osteoarthritis Cartilage. 2001 Jul;9(5):440-6. doi: 10.1053/joca.2000.0410.

    PMID: 11467892BACKGROUND
  • Alghadir A, Anwer S. Effect of retro and forward walking on quadriceps muscle strength, pain, function, and mobility in patients with knee osteoarthritis: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Apr 12;17:161. doi: 10.1186/s12891-016-1021-z.

    PMID: 27072798BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Zeynep Yıldız Kızkın, Dr.

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 22, 2025

Study Start

September 20, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations