Quadriceps Muscle Quality and Clinical Outcomes in Knee Osteoarthritis

NCT07541274 | Enrolling By Invitation

• 1 other identifier: HIC26
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthritis, Osteoarthritis; Osteo Arthritis of the Knee

Keywords

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

Outcome Measures

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 higher score indicates better physical function.

  Baseline

Secondary Outcomes (3)

• Pain Intensity via Visual Analog Scale (VAS)

  Baseline

• Knee Injury and Osteoarthritis Outcome Score - Quality of Life (KOOS-QoL)

  Baseline

• Patient Global Assessment (PtGA)

  Baseline

Study Arms (2)

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).

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

Izmir Cıty Hospital

Izmir, Bayraklı/izmir, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25787260 BACKGROUND

• 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.

  PMID: 29128879 BACKGROUND

• 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.

  PMID: 40633265 BACKGROUND

• 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.

  PMID: 13498604 BACKGROUND

• 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.

  PMID: 23948834 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• Buğra İnce

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

TU (1)