ClinicalTrials.gg
CompletedNCT07541274Updated Oct 1, 2026

Quadriceps Muscle Quality and Clinical Outcomes in Knee Osteoarthritis

An observational study in Knee Arthritis, Osteoarthritis and Osteo Arthritis of the Knee, sponsored by Izmir City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Primary conditionOsteoarthritis, KneeRegistry: OsteoarthritisReclassifiedWhy we changed it
Registry
Osteoarthritis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoarthritis, Knee
Why
  1. The study's title name Osteoarthritis, Knee, a narrower term within Osteoarthritis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Izmir City Hospital · Observational

Updated Oct 1, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
40 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 268 studies in Osteoarthritis, Knee with a site in Turkey — 54 open to participants now, 66 under way, 3 of them phase 3. Osteoarthritis, Knee · Turkey.

Enrollment
49th of 70
60 · median 84
Started
2026
with 37 others
Observational
70 of 268
21 open now
Registered
234th of 268
by date

Among the 268 studies in Osteoarthritis, Knee with a site in Turkey, this one is the 49th largest by enrollment of the 70 observational ones that give a count, is one of 38 that started in 2026, is one of 70 observational ones, and was the 234th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

54 of the 268 studies in Osteoarthritis, Knee with a site in Turkey are open now. Recruiting first, the newest first:

49 more — sign in →

All 54 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 40 Years to 70 Years · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 268 studies in Osteoarthritis, Knee with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Knee Arthritis, Osteoarthritis
  • Osteo Arthritis of the Knee

Browse trials for

Keywords

  • Knee Osteoarthritis
  • Ultrasonography
  • Quadriceps Muscle Thickness
  • Quadriceps Echogenicity
  • Knee Injury and Osteoarthritis Outcome Score
  • KOOS
04

In context

Osteoarthritis, Knee Reclassified

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Izmir City Hospital is the lead sponsor of 25 studies on the registry; 12 are open to participants now.

Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • History of knee surgery within the last 6 months
  • Intra-articular injection (e.g., , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

06

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

08

Study locations

1 site
  • Izmir Cıty Hospital
    Izmir, Bayraklı/izmir, Turkey (Türkiye)
09

References and documents

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 25787260 ↗
  • Tolk 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 29128879 ↗
  • Carvalho 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 40633265 ↗
  • KELLGREN 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 13498604 ↗
  • Gul 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 ↗

Individual participant data

Plan to share: Undecided — No final decision has yet been made regarding the future availability of the data.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Apr 2026 to primary completion in Sep 2026, 5 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: primary completion Dec 2026 → Sep 2026 and completion Dec 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 21, 2026
StartActual
Apr 14, 2026
Primary completionActual
Sep 28, 2026was Dec 2026
CompletionActual
Sep 28, 2026was Dec 2026
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 1, 2026
Primary completion
Dec 2026→Sep 28, 2026 (actual)
Oct 1, 2026
Study completion
Dec 2026→Sep 28, 2026 (actual)
Oct 1, 2026
Enrollment
58 (estimated)→60 (actual)
Oct 1, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionKnee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS): how it is measured was reworded
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Recruiting→Completed
    Primary completion Dec 2026→Sep 28, 2026 (now actual)
    Study completion Dec 2026→Sep 28, 2026 (now actual)
    Enrollment 58 (estimated)→60 (actual)
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionKnee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS): how it is measured was reworded
    + 4 other changes: verification date, description, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07541274
Lead sponsor
Izmir City Hospital
Responsible party
Bugra Ince (Associate Professor, MD, Izmir City Hospital) — Principal investigator
First posted
Apr 21, 2026
Start date
Apr 14, 2026
Primary completion
Sep 28, 2026
Completion
Sep 28, 2026
Last update
Oct 1, 2026

Study contacts

Buğra İnce
principal investigator · Izmir City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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