Osteo Arthritis KneeKOOS-12NCT04277676
Reliability and Validity of Turkish Version of Knee Injury and Osteoarthritis Outcome Score-12
An observational study of Osteo Arthritis Knee, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 25 Apr 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The study resides in the province of Istanbul
- 18 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
- 120 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alptekin Physical Therapy and Rehabilitation Clinic
Istanbul, Beşiktaş/İstanbul, 34340
About this study
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.
Read the detailed description
Osteoarthritis (OA) is a chronic degenerative disease characterized by the loss of articular cartilage, causing destruction in periarticular bone tissue, leading to a decrease in daily life and quality of life due to pain despite its slow progression.
When the knee osteoarthritis Looking at the prevalence among people living in Turkey, compared to males more can be seen, 14.8% of the 50 and older population in knee OA incidence, 22.5% of the incidence in women, while men were determined to be 8%.
Risk factors that affect the development of knee OA include obesity, traumas, chondrocalcinosis, nutritional factors, genetics, smoking, estrogen replacement, muscular weakness, and professional or sports activities. The individual with knee OA especially; It is applied to the physician with the complaints of increased pain during walking, climbing and climbing stairs, stiffness in the joint, crepitation and limited range of motion.
Diagnosis is determined based on knee OA, clinical and radiological evaluations; According to the radiological changes seen, the stage of the disease is determined by Kellgren Lawrence staging (Stage 0-4). Purposes in the treatment of knee OA; patient education, pain control, increasing functionality and reducing the impact of disability on daily life. The optimal treatment approach involves the application of non-pharmacological and pharmacological treatments together.
Functional evaluation methods are of great importance in planning the right treatment approach and evaluating treatment effectiveness due to the negative impact of individuals on daily life activities. Functional evaluation of the individual; daily life activities, professional activities, leisure activities, social relationships and their skills in performing these tasks are carried out with objective, generic or disease-specific scales. Various scales have been developed in individuals with knee OA that allow an objective evaluation of functions. Among these scales, Western Ontario and McMaster Universities Osteoarthritis Index (Western Ontario and McMaster Universities Osteoarthritis Index: WOMAC), Lequesne Index, Knee-Hip Osteoarthritis Life Quality Scale (Osteoarthritis of Knee Hip Quality Of Life Questionnaire: OAKHQOL), Knee osteoarthritis and Knee Injury and Knee Injury and Osteoarthritis Outcome Score: KOOS.
These questionnaires, which are reported by the patients, are not routinely used in the clinic due to the length of the questionnaires, which are used to determine the problems caused by joint problems in daily life and quality of life. Therefore, patient-based scales that can be used in the clinic should be short, and include questions that can evaluate pain, function and quality of life. Although the short form of the KOOS questionnaire has been developed, KOOS-PS only measures the effects of knee osteoarthritis on physical function. Consisting of 12 questions considering that the KOOS scale is long in routine, clinic use; A short form of KOOS-12 was created, which included the assessment sections of pain, function and knee-specific quality of life. The application of the KOOS-12 scale takes 2 minutes. The short form of KOOS-12 was found to be a valid and reliable scale in individuals who underwent total knee arthroplasty. The purpose of our study; Turkish reliability and validity of the Knee Osteoarthritis and Knee Injury and Osteoarthritis Result Score-12 scale.
- Conditions
- Osteo Arthritis Knee
- Keywords
- KOOS, Knee, Osteoarthritis, Patient-reported outcome measures, Psychometrics
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: change from baseline activities od daşly living at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Feb 2020
- Primary completion25 Mar 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Ataş Balcı, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277676
- Sponsor's protocol ID
- 22481095-020-4023
- Acronym
- KOOS-12
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 3741515Felson 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.
PubMed 2287948Roos 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.
PubMed 9699158Scott 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.
PubMed 11092795Recommendations 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.
PubMed 11014340Bellamy 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.
PubMed 12465137Faucher 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.
PubMed 14667565Roos 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.
PubMed 14613558Zhang 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.
PubMed 18687270Hunter 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.
PubMed 18687278Gandek 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.
PubMed 30716536
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Turkish Version of Knee Injury and Osteoarthritis Outcome Score-12
- ClinicalTrials.gov ID
- NCT04277676
- Acronym / sponsor ID
- KOOS-12 / 22481095-020-4023
- Conditions
- Osteo Arthritis Knee
- Keywords
- KOOS, Knee, Osteoarthritis, Patient-reported outcome measures, Psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 20 Feb 2020 (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.
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.
Detailed description
Osteoarthritis (OA) is a chronic degenerative disease characterized by the loss of articular cartilage, causing destruction in periarticular bone tissue, leading to a decrease in daily life and quality of life due to pain despite its slow progression.
When the knee osteoarthritis Looking at the prevalence among people living in Turkey, compared to males more can be seen, 14.8% of the 50 and older population in knee OA incidence, 22.5% of the incidence in women, while men were determined to be 8%.
Risk factors that affect the development of knee OA include obesity, traumas, chondrocalcinosis, nutritional factors, genetics, smoking, estrogen replacement, muscular weakness, and professional or sports activities. The individual with knee OA especially; It is applied to the physician with the complaints of increased pain during walking, climbing and climbing stairs, stiffness in the joint, crepitation and limited range of motion.
Diagnosis is determined based on knee OA, clinical and radiological evaluations; According to the radiological changes seen, the stage of the disease is determined by Kellgren Lawrence staging (Stage 0-4). Purposes in the treatment of knee OA; patient education, pain control, increasing functionality and reducing the impact of disability on daily life. The optimal treatment approach involves the application of non-pharmacological and pharmacological treatments together.
Functional evaluation methods are of great importance in planning the right treatment approach and evaluating treatment effectiveness due to the negative impact of individuals on daily life activities. Functional evaluation of the individual; daily life activities, professional activities, leisure activities, social relationships and their skills in performing these tasks are carried out with objective, generic or disease-specific scales. Various scales have been developed in individuals with knee OA that allow an objective evaluation of functions. Among these scales, Western Ontario and McMaster Universities Osteoarthritis Index (Western Ontario and McMaster Universities Osteoarthritis Index: WOMAC), Lequesne Index, Knee-Hip Osteoarthritis Life Quality Scale (Osteoarthritis of Knee Hip Quality Of Life Questionnaire: OAKHQOL), Knee osteoarthritis and Knee Injury and Knee Injury and Osteoarthritis Outcome Score: KOOS.
These questionnaires, which are reported by the patients, are not routinely used in the clinic due to the length of the questionnaires, which are used to determine the problems caused by joint problems in daily life and quality of life. Therefore, patient-based scales that can be used in the clinic should be short, and include questions that can evaluate pain, function and quality of life. Although the short form of the KOOS questionnaire has been developed, KOOS-PS only measures the effects of knee osteoarthritis on physical function. Consisting of 12 questions considering that the KOOS scale is long in routine, clinic use; A short form of KOOS-12 was created, which included the assessment sections of pain, function and knee-specific quality of life. The application of the KOOS-12 scale takes 2 minutes. The short form of KOOS-12 was found to be a valid and reliable scale in individuals who underwent total knee arthroplasty. The purpose of our study; Turkish reliability and validity of the Knee Osteoarthritis and Knee Injury and Osteoarthritis Result Score-12 scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- The study resides in the province of Istanbul
- 18 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
Key exclusion criteria (4 listed)
- 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
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
Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12)
Time frame: change from baseline activities od daşly living at 2 weeks
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.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: change from baseline activities od daşly living at 2 weeks
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).
Short Form-36 (SF-36)
Time frame: change from baseline activities od daşly living at 2 weeks
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).
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 21 Feb 2021.
- Results publication: 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.
- Results publication: PubMed 2287948Felson 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.
- Results publication: PubMed 9699158Roos 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.
- Results publication: PubMed 11092795Scott 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.
- Results publication: PubMed 11014340Recommendations 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.
- Results publication: PubMed 12465137Bellamy 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.
- Results publication: PubMed 14667565Faucher 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.
- Results publication: PubMed 14613558Roos 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.
- Results publication: PubMed 18687270Zhang 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.
- Results publication: PubMed 18687278Hunter 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.
- Results publication: PubMed 30716536Gandek 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.
- Şencan H. Sosyal ve davranışsal ölçümlerde güvenilirlik ve geçerlilik. 1.Baskı. Ankara: Seçkin Yayınevi, 2005; 384-386Link provided by the sponsor.
- Granger CV, Black T, Braun SL. Quality and outcome measures for medical rehabilitation. In: Braddom RL (Ed). Physical Medicine and Rehabilitation. 3rd Edition. China, Saunders Elseiver, China, 2007, pp 151-64.Link provided by the sponsor.
- Kutsal Y, Kara M. Diz Osteoartriti. M S, editor. İstanbul: Nobel Tıp Kitabevi; 2007. s. 149-161.Link provided by the sponsor.
- Karakoç FY, Dönmez L. Ölçek Geli̇şti̇rme Çalışmalarında Temel İlkeler. Tıp Eğitimi Dünyası. 2014; 40: 39-49Link provided by the sponsor.
- The European Musculoskeletal Conditions Surveillance. Musculoskeletal health in europe report v5.0 (online) 2016: (3 screens). Available from: URL: http://www.eumusc.net/myUploadData/files/Musculoskeletal%20Health%20in%20 Europe%20Report%20v5.pdf.Link provided by the sponsor.
- Göksoy T, Romatizmal Hastalıkların Tanı ve Tedavisi. İç: Cerrahoğlu L, Kokino S, editör. Osteoartrit. Yüce Yay; 2002. S.379- 405Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteo Arthritis Knee, run by Bahçeşehir 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 7 inclusion and 4 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 21 Feb 2021. 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?
Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12) (time frame: change from baseline activities od daşly living at 2 weeks). The study lists 3 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 NCT04277676, which also lists 11 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 21 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.