NCT04277676

Brief Summary

Approximately 120 patients who have been diagnosed with knee osteoarthritis but have not previously operated due to this disease and who are in Kellgren Lawrence stage 2 and 3 will be compared with the KOOS scale and Short Form-36 (Short Form-36: SF-36) scales to investigate the validity and reliability of the Turkish version of KOOS-12.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

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

February 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 6, 2020

Last Update Submit

February 18, 2021

Conditions

Keywords

KOOSKneeOsteoarthritisPatient-reported outcome measuresPsychometrics

Outcome Measures

Primary Outcomes (3)

  • Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12)

    Scale; It consists of three parts: pain (4 items), function (4 items) and knee-specific quality of life (4 items). KOOS-12; in pain sub-item; In the sub-item of walking on a flat ground, going up and down stairs, sitting-reaching, function and daily life; There are patient-specific questions in the sub-item of quality of life, sitting up, standing, getting in and out of the car, turning the affected knee. The total scores obtained from the items in the KOOS-12 scale are calculated and the average of the total score is taken from the three sub-dimensions. If any of the three sub-item scores are missing, the average score cannot be calculated.

    change from baseline activities od daşly living at 2 weeks

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    It is a questionnaire designed by Roos et al. From the Likert 3.0 version of the WOMAC osteoarthritis index to evaluate the pain, functional status, daily life activity and quality of life of patients with knee osteoarthritis (Roos EM. et al. 1998). Scale; consists of five subgroups and 42 questions: pain, string-related quality of life, daily life activities, sports and leisure activities. Individuals score the questions between 0-4 according to the 5-point Likert scale, based on the symptoms felt in the knee, taking into account the past week. While 100 points indicate that there are no symptoms in the scale, 0 points indicate that there are severe symptoms. The subscale score is calculated by dividing the average scores of each sub-dimension separately into 4. The Turkish validity and reliability study of the scale was conducted. (Sabırlı F. et al. 2007). It takes 10 minutes to apply the scale (Roos EM. et al. 2003, Paker N. et al. 2007).

    change from baseline activities od daşly living at 2 weeks

  • Short Form-36 (SF-36)

    It is a scale that is used to evaluate the overall quality of life consisting of eight sub-scales and 36 questions and allows the individual to evaluate himself. Scale; physical function, physical role, emotional role, pain, vitality, general health and mental health sub-dimensions. Each subscale is scored between 0-100 and "0" indicates the lowest and "100" shows the best quality of life. The questionnaire has Turkish validity and reliability (Kocyigit H. et al. 1999).

    change from baseline activities od daşly living at 2 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In determining the individuals who will participate in the study; face to face interviews and social media groups (whatsapp, facebook, instagram etc.) will be used. Individuals diagnosed with osteoarthritis by the physician at the Alptekin Physical Therapy Clinic will be included.

You may qualify if:

  • The study resides in the province of Istanbul
  • years and older
  • Who have been diagnosed with knee osteoarthritis
  • In Kellgren Lawrence Staging; Stage 2 and 3 detected
  • Not operated after knee osteoarthritis after diagnosis
  • Literate
  • individuals who agree to participate in the study will be included. For the validity of the questionnaire, it must be applied to at least 10 times the number of questions in the questionnaire. In this context, it is planned to be included in the study with at least 120 people.

You may not qualify if:

  • Those diagnosed with hip and ankle OA
  • Those with neurological diseases affecting their lower extremities
  • Those with knee pain due to rheumatoid arthritis, anterior cruciate ligament injury and menisectomy
  • Those who had a total knee arthroplasty operation in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alptekin Physical Therapy and Rehabilitation Clinic

Istanbul, Beşiktaş/İstanbul, 34340, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

  • Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990 Dec;20(3 Suppl 1):42-50. doi: 10.1016/0049-0172(90)90046-i.

  • Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

  • Scott DL, Garrood T. Quality of life measures: use and abuse. Baillieres Best Pract Res Clin Rheumatol. 2000 Dec;14(4):663-87. doi: 10.1053/berh.2000.0106.

  • Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.

  • Bellamy N. WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire. J Rheumatol. 2002 Dec;29(12):2473-6. No abstract available.

  • Faucher M, Poiraudeau S, Lefevre-Colau MM, Rannou F, Fermanian J, Revel M. Assessment of the test-retest reliability and construct validity of a modified Lequesne index in knee osteoarthritis. Joint Bone Spine. 2003 Dec;70(6):521-5. doi: 10.1016/s1297-319x(03)00070-8.

  • Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 2008 Aug;34(3):515-29. doi: 10.1016/j.rdc.2008.05.007.

  • Hunter DJ, Lo GH. The management of osteoarthritis: an overview and call to appropriate conservative treatment. Rheum Dis Clin North Am. 2008 Aug;34(3):689-712. doi: 10.1016/j.rdc.2008.05.008.

  • Gandek B, Roos EM, Franklin PD, Ware JE Jr. A 12-item short form of the Knee injury and Osteoarthritis Outcome Score (KOOS-12): tests of reliability, validity and responsiveness. Osteoarthritis Cartilage. 2019 May;27(5):762-770. doi: 10.1016/j.joca.2019.01.011. Epub 2019 Feb 1.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 20, 2020

Study Start

February 20, 2020

Primary Completion

March 25, 2020

Study Completion

April 25, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations