Knee Arthritis, OsteoarthritisNCT07541274
Quadriceps Muscle Quality and Clinical Outcomes in Knee Osteoarthritis
An observational study of Knee Arthritis, Osteoarthritis and Osteo Arthritis of the Knee, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this cross-sectional, observational study is to evaluate the relationship between quadriceps muscle quality-specifically muscle echogenicity and thickness change during isometric contraction-and clinical outcomes such as pain, physical function, quality of life, and Patient Global Assessment (PtGA) in… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis, Osteoarthritis, Osteo Arthritis of the Knee
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2026to 28 Sep 2026
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients aged 40-70 years diagnosed with knee osteoarthritis (OA) who apply to the Physical Medicine and Rehabilitation Clinic of Izmir City Hospital will be screened according to the study criteria. Individuals diagnosed clinically and radiographically with Kellgren-Lawrence Grade 2-3 knee osteoarthritis, who are capable of performing isometric quadriceps contractions, and who volunteer to participate in the study will be included after signing the informed consent form.
Who may be able to join
- Female sex
- Aged between 40 and 70 years
- Diagnosed with clinical and radiographic primary knee osteoarthritis (Kellgren-Lawrence Grade 2 or 3)
- Ability to perform isometric contraction at 90° of knee flexion
- Voluntary participation and provision of written informed consent
Who cannot join
- History of knee surgery within the last 6 months
- Intra-articular injection (e.g., corticosteroids, hyaluronic acid) within the last 3 months
- Presence of inflammatory rheumatic diseases (e.g., Rheumatoid Arthritis, Spondyloarthropathy)
- Known neuromuscular disorders affecting the lower extremities
- Severe cardiopulmonary comorbidities that prevent participation in clinical assessments
- Severe patellofemoral instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Quadriceps Muscle Echogenicity and Thickness Change During Isometric Contraction With Pain, Function, Quality of Life, and Patient Global Assessment in Knee Osteoarthritis
The purpose of this cross-sectional, observational study is to evaluate the relationship between quadriceps muscle quality-specifically muscle echogenicity and thickness change during isometric contraction-and clinical outcomes such as pain, physical function, quality of life, and Patient Global Assessment (PtGA) in female patients with knee osteoarthritis. Participants will undergo a non-invasive ultrasound evaluation of their thigh muscles and complete standard clinical questionnaires to help determine how muscle structural and functional properties impact the daily lives of patients with knee osteoarthritis.
Read the detailed description
Knee osteoarthritis (OA) is a highly prevalent degenerative joint disease characterized by pain, loss of function, and reduced quality of life. A critical factor related to the clinical course of the disease is quadriceps muscle weakness and deterioration in muscle quality, including intra-muscular fatty infiltration and fibrotic changes.
This single-center, cross-sectional observational study aims to comprehensively assess quadriceps muscle quality using ultrasonography (USG) and investigate its relationship with core clinical outcomes in patients with knee OA. Specifically, the study will measure muscle echogenicity (a surrogate marker of fat infiltration and fibrosis) and the rate of muscle thickness change during maximum voluntary isometric contraction (MVIC), which reflects the dynamic functional response of the muscle.
Female patients aged 40 to 70 years with radiographically confirmed Kellgren-Lawrence grade 2-3 knee OA will be recruited from the physical medicine and rehabilitation clinic. Following informed consent, participants will undergo clinical assessments using standardized patient-reported outcome measures. These include the Visual Analog Scale (VAS) for pain intensity, the Patient Global Assessment (PtGA), and the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales for physical function (KOOS-PS) and quality of life (KOOS-QoL).
Ultrasonographic evaluations will be performed by a single evaluator using a linear high-resolution probe (5-10 MHz). Rectus femoris (RF) and vastus intermedius (VI) muscle thicknesses will be recorded at rest and during a 5-second MVIC to calculate the thickness change ratio. Furthermore, muscle echogenicity (mean gray value) will be quantified via image analysis software and mathematically corrected for subcutaneous fat thickness to ensure accuracy.
By evaluating both the structural and functional ultrasonographic features of the quadriceps muscle simultaneously, this study seeks to provide a holistic understanding of how muscle quality impacts the core outcome domains recommended by OMERACT-OARSI for knee osteoarthritis, ultimately contributing to better prognostication and more individualized rehabilitation strategies.
- Keywords
- Knee Osteoarthritis, Ultrasonography, Quadriceps Muscle Thickness, Quadriceps Echogenicity, Knee Injury and Osteoarthritis Outcome Score, KOOS
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Knee Injuries
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 |
|---|---|---|
| Female Patients with Knee Osteoarthritis | This group consists of female patients aged 40-70 years diagnosed with primary knee osteoarthritis (Kellgren-Lawrence Grade 2 and 3) according to the American College of Rheumatology (ACR) criteria. All participants in this cohort will undergo: 1. Ultrasonographic Assessment: Measurement of Rectus Femoris and Vastus Intermedius muscle thickness at rest and during maximum voluntary isometric contraction, along with muscle echogenicity analysis. 2. Clinical Evaluation: Assessment of pain intensity via Visual Analog Scale (VAS), and evaluation of functional status and quality of life using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Patient Global Assessment (PtGA). | |
| Healthy Control Group | This group consists of healthy female volunteers aged 40-70 years with no clinical or radiographic evidence of knee osteoarthritis and no history of chronic knee pain. Participants in this control group will undergo the same standardized evaluation protocol as the patient group to provide baseline values for: 1. Ultrasonographic Assessment: Measurement of Rectus Femoris and Vastus Intermedius muscle thickness at rest and during maximum voluntary isometric contraction, along with muscle echogenicity analysis. 2. Clinical Evaluation: Assessment of pain intensity via Visual Analog Scale (VAS), and evaluation of functional status and quality of life using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Patient Global Assessment (PtGA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)
The primary outcome is physical function, reflecting the capacity to perform activities of daily living. KOOS-PS is a 7-item patient-reported measure assessing functional difficulties (e.g., getting in/out of bed, putting on socks, squatting). Scores for each item range from 0 to 4, and the total score is transformed to a 0-100 scale. A lower score indicates better physical function.
Measured: Baseline
Secondary outcomes (3)
Pain Intensity via Visual Analog Scale (VAS)
Participants' pain levels will be assessed using the Visual Analogue Scale (VAS). The VAS is a validated tool designed to convert subjective sensations, such as pain, into quantitative data. During the assessment, a 10-cm horizontal line will be utilized, with the endpoints defined as '0: No pain' and '10: Most severe pain imaginable.' Patients will be instructed to mark the point on this line that best represents their current pain intensity.
Measured: Baseline
Knee Injury and Osteoarthritis Outcome Score - Quality of Life (KOOS-QoL)
This 4-item subscale evaluates the impact of knee problems on the patient's quality of life, including awareness of knee problems, lifestyle modifications to protect the knee, lack of confidence in the knee, and general knee-related difficulties. Each item is scored on a Likert scale from 0 to 4. The raw scores are transformed to a 0-100 scale, where 100 represents no symptoms/best possible quality of life and 0 represents extreme symptoms/worst possible quality of life.
Measured: Baseline
Patient Global Assessment (PtGA)
The Patient Global Assessment (PtGA) is a patient-reported outcome measure reflecting the individual's subjective perception of their overall knee joint status. It integrates the general impact of knee osteoarthritis on the patient's life, including symptom severity and functional burden, into a single indicator. In this study, PtGA will be measured using a 0-10 cm Visual Analog Scale (VAS) based on the standard question: "How would you rate your knee condition in general over the past 7 days?". The scale ranges from 0 (very well) to 10 (very poor). The VAS provides a one-dimensional, practical, and validated method to quantify the patient's global health status related to the knee joint.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start14 Apr 2026
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee Arthritis, 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bugra Ince, Izmir City Hospital
- Investigators
- Buğra İnce, Principal investigator, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541274
- Sponsor's protocol ID
- HIC26
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No final decision has yet been made regarding the future availability of the data.
Publications
Young HJ, Jenkins NT, Zhao Q, Mccully KK. Measurement of intramuscular fat by muscle echo intensity. Muscle Nerve. 2015 Dec;52(6):963-71. doi: 10.1002/mus.24656. Epub 2015 Sep 7.
PubMed 25787260Tolk JJ, Janssen RPA, Prinsen CAC, Latijnhouwers DAJM, van der Steen MC, Bierma-Zeinstra SMA, Reijman M. The OARSI core set of performance-based measures for knee osteoarthritis is reliable but not valid and responsive. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2898-2909. doi: 10.1007/s00167-017-4789-y. Epub 2017 Nov 11.
PubMed 29128879Carvalho MTX, Pinheiro VHG, Alberton CL. Ultrasonographic assessment of quadriceps muscle in people with knee osteoarthritis: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2025 Oct;68(7):101998. doi: 10.1016/j.rehab.2025.101998. Epub 2025 Jul 8.
PubMed 40633265KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604Gul ED, Yilmaz O, Bodur H. Reliability and validity of the Turkish version of the knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS). J Back Musculoskelet Rehabil. 2013;26(4):461-6. doi: 10.3233/BMR-130406.
PubMed 23948834
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Quadriceps Muscle Echogenicity and Thickness Change During Isometric Contraction With Pain, Function, Quality of Life, and Patient Global Assessment in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07541274
- Acronym / sponsor ID
- HIC26
- Keywords
- Knee Osteoarthritis, Ultrasonography, Quadriceps Muscle Thickness, Quadriceps Echogenicity, Knee Injury and Osteoarthritis Outcome Score, KOOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 21 Apr 2026 (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 purpose of this cross-sectional, observational study is to evaluate the relationship between quadriceps muscle quality-specifically muscle echogenicity and thickness change during isometric contraction-and clinical outcomes such as pain, physical function, quality of life, and Patient Global Assessment (PtGA) in female patients with knee osteoarthritis. Participants will undergo a non-invasive ultrasound evaluation of their thigh muscles and complete standard clinical questionnaires to help determine how muscle structural and functional properties impact the daily lives of patients with knee osteoarthritis.
Detailed description
Knee osteoarthritis (OA) is a highly prevalent degenerative joint disease characterized by pain, loss of function, and reduced quality of life. A critical factor related to the clinical course of the disease is quadriceps muscle weakness and deterioration in muscle quality, including intra-muscular fatty infiltration and fibrotic changes.
This single-center, cross-sectional observational study aims to comprehensively assess quadriceps muscle quality using ultrasonography (USG) and investigate its relationship with core clinical outcomes in patients with knee OA. Specifically, the study will measure muscle echogenicity (a surrogate marker of fat infiltration and fibrosis) and the rate of muscle thickness change during maximum voluntary isometric contraction (MVIC), which reflects the dynamic functional response of the muscle.
Female patients aged 40 to 70 years with radiographically confirmed Kellgren-Lawrence grade 2-3 knee OA will be recruited from the physical medicine and rehabilitation clinic. Following informed consent, participants will undergo clinical assessments using standardized patient-reported outcome measures. These include the Visual Analog Scale (VAS) for pain intensity, the Patient Global Assessment (PtGA), and the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales for physical function (KOOS-PS) and quality of life (KOOS-QoL).
Ultrasonographic evaluations will be performed by a single evaluator using a linear high-resolution probe (5-10 MHz). Rectus femoris (RF) and vastus intermedius (VI) muscle thicknesses will be recorded at rest and during a 5-second MVIC to calculate the thickness change ratio. Furthermore, muscle echogenicity (mean gray value) will be quantified via image analysis software and mathematically corrected for subcutaneous fat thickness to ensure accuracy.
By evaluating both the structural and functional ultrasonographic features of the quadriceps muscle simultaneously, this study seeks to provide a holistic understanding of how muscle quality impacts the core outcome domains recommended by OMERACT-OARSI for knee osteoarthritis, ultimately contributing to better prognostication and more individualized rehabilitation strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Patients with Knee Osteoarthritis | – | –This group consists of female patients aged 40-70 years diagnosed with primary knee osteoarthritis (Kellgren-Lawrence Grade 2 and 3) according to the American College of Rheumatology (ACR) criteria. All participants in this cohort will undergo: 1. Ultrasonographic Assessment: Measurement of Rectus Femoris and Vastus Intermedius muscle thickness at rest and during maximum voluntary isometric contraction, along with muscle echogenicity analysis. 2. Clinical Evaluation: Assessment of pain intensity via Visual Analog Scale (VAS), and evaluation of functional status and quality of life using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Patient Global Assessment (PtGA). |
| Healthy Control Group | – | –This group consists of healthy female volunteers aged 40-70 years with no clinical or radiographic evidence of knee osteoarthritis and no history of chronic knee pain. Participants in this control group will undergo the same standardized evaluation protocol as the patient group to provide baseline values for: 1. Ultrasonographic Assessment: Measurement of Rectus Femoris and Vastus Intermedius muscle thickness at rest and during maximum voluntary isometric contraction, along with muscle echogenicity analysis. 2. Clinical Evaluation: Assessment of pain intensity via Visual Analog Scale (VAS), and evaluation of functional status and quality of life using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Patient Global Assessment (PtGA). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 40-70 years diagnosed with knee osteoarthritis (OA) who apply to the Physical Medicine and Rehabilitation Clinic of Izmir City Hospital will be screened according to the study criteria. Individuals diagnosed clinically and radiographically with Kellgren-Lawrence Grade 2-3 knee osteoarthritis, who are capable of performing isometric quadriceps contractions, and who volunteer to participate in the study will be included after signing the informed consent form.
Key inclusion criteria (5 listed)
- Female sex
- Aged between 40 and 70 years
- Diagnosed with clinical and radiographic primary knee osteoarthritis (Kellgren-Lawrence Grade 2 or 3)
- Ability to perform isometric contraction at 90° of knee flexion
- Voluntary participation and provision of written informed consent
Key exclusion criteria (6 listed)
- History of knee surgery within the last 6 months
- Intra-articular injection (e.g., corticosteroids, hyaluronic acid) within the last 3 months
- Presence of inflammatory rheumatic diseases (e.g., Rheumatoid Arthritis, Spondyloarthropathy)
- Known neuromuscular disorders affecting the lower extremities
- Severe cardiopulmonary comorbidities that prevent participation in clinical assessments
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 - Physical Function Short Form (KOOS-PS)
Time frame: Baseline
The primary outcome is physical function, reflecting the capacity to perform activities of daily living. KOOS-PS is a 7-item patient-reported measure assessing functional difficulties (e.g., getting in/out of bed, putting on socks, squatting). Scores for each item range from 0 to 4, and the total score is transformed to a 0-100 scale. A lower score indicates better physical function.
3 secondary outcomes
Pain Intensity via Visual Analog Scale (VAS)
Time frame: Baseline
Knee Injury and Osteoarthritis Outcome Score - Quality of Life (KOOS-QoL)
Time frame: Baseline
Patient Global Assessment (PtGA)
Time frame: Baseline
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 1 Oct 2026.
- Background: PubMed 25787260Young HJ, Jenkins NT, Zhao Q, Mccully KK. Measurement of intramuscular fat by muscle echo intensity. Muscle Nerve. 2015 Dec;52(6):963-71. doi: 10.1002/mus.24656. Epub 2015 Sep 7.
- Background: PubMed 29128879Tolk JJ, Janssen RPA, Prinsen CAC, Latijnhouwers DAJM, van der Steen MC, Bierma-Zeinstra SMA, Reijman M. The OARSI core set of performance-based measures for knee osteoarthritis is reliable but not valid and responsive. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2898-2909. doi: 10.1007/s00167-017-4789-y. Epub 2017 Nov 11.
- Background: PubMed 40633265Carvalho MTX, Pinheiro VHG, Alberton CL. Ultrasonographic assessment of quadriceps muscle in people with knee osteoarthritis: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2025 Oct;68(7):101998. doi: 10.1016/j.rehab.2025.101998. Epub 2025 Jul 8.
- Background: PubMed 13498604KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
- Background: PubMed 23948834Gul ED, Yilmaz O, Bodur H. Reliability and validity of the Turkish version of the knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS). J Back Musculoskelet Rehabil. 2013;26(4):461-6. doi: 10.3233/BMR-130406.
- Individual participant dataSharing planned: Undecided. No final decision has yet been made regarding the future availability of the data.
Related trials for Knee Arthritis, Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Buğra İnce principal investigator
Izmir City Hospital
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 Knee Arthritis, Osteoarthritis and Osteo Arthritis of the Knee, run by Izmir City Hospital 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 5 inclusion and 6 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 1 Oct 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?
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) (time frame: Baseline). 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 NCT07541274, which also lists 5 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 1 Oct 2026.