An observational study in Lipedema, Knee Osteoarthritis and Knee Acute and Chronic Pain, sponsored by Izmir Democracy University. Recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Izmir Democracy University · Observational
This study will be one of the few to examine the effect of lipedema on knee osteoarthritis in a comparative manner with a control group within the same osteoarthritis context. Although the relationship between obesity and osteoarthritis has been extensively studied in the literature, the effect of specific adipose tissue pathologies, such as lipedema, on osteoarthritis has not been sufficiently investigated. This study aims to demonstrate the independent effect of lipedema on osteoarthritis, evaluate clinical and ultrasonographic parameters together, and contribute to early diagnosis and targeted rehabilitation strategies.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 76 is below the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Izmir Democracy University is the lead sponsor of 78 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include patients aged 30 and older who presented to the Physical Medicine and Rehabilitation Outpatient Clinic at Buca Seyfi Demirsoy Training and Research Hospital, Izmir Democracy University, between July 15, 2026, and July 15, 2027, and who were diagnosed with knee osteoarthritis based on clinical and radiological evaluations. Previously obtained knee X-rays will be retrospectively reviewed, and patients with osteoarthritis findings on X-rays according to the Kellgren-Lawrence grading system will be included in the study. The diagnosis of lipedema will be made by an experienced physical therapy and rehabilitation specialist based on a combined evaluation of clinical and ultrasonographic findings. The clinical diagnosis will be based on the Wold criteria: bilateral and symmetrical fat distribution in the lower extremities, foot sparing, tenderness and pain on palpation, a history of easy bruising, and fat accumulation resistant to diet and exercise.
Inclusion Criteria:
All participants (Group 1 + Group 2)
Group 1 (knee osteoarthritis with lipedema):
Group 2 (knee osteoarthritis without lipedema):
Exclusion Criteria:
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Knee osteoarthritis with lipedema
Knee osteoarthritis without lipedema
Ultrasonography-based measurements of femoral cartilage thickness
During femoral cartilage thickness measurements, participants will be positioned in the supine position, and the knee will be brought to maximum flexion for evaluation through the suprapatellar window. The probe will be positioned in the transverse plane, and measurements will be taken at the level of the medial and lateral femoral condyles and the intercondylar groove. For standardization, each measurement will be repeated three times, and the average will be recorded. Cartilage thickness will be defined as the distance between the hypoechoic cartilage layer and the subchondral bone surface. Lower values indicate that osteoarthritis has caused more structural damage.
Time frame: Day 1
Western Ontario and McMaster Universities (WOMAC) score
The WOMAC Osteoarthritis Index questionnaire, consisting of 5 questions using a Likert scale, is provided in the attached case report form to assess pain, stiffness, and daily living functions. The WOMAC Osteoarthritis Index consists of 24 questions covering three subscales: pain (5 questions), stiffness (2 questions), and function (17 questions). The scoring system consists of the WOMAC pain score, WOMAC stiffness score, WOMAC function score, and WOMAC total score. A Turkish validity and reliability study has been conducted.
Time frame: Day 1
Visual analog scale
Visual analog scale measures pain as it is subjectively perceived. It uses a 0-10 cm scale, the most commonly used tool for quantitatively determining pain intensity, with one end representing no pain and the other end representing the most severe pain possible. '0' indicates no pain, while '10' indicates the most severe pain. The individual is asked to select the numerical value that best represents their condition. This marked value is used as numerical data to determine the level of pain perception. A higher score indicates a higher level of pain.
Time frame: Day 1
Joint Range of Motion measurement
Knee flexion and extension will be measured bilaterally using universal goniometry to assess patients' joint range of motion, and the angles will be recorded.
Time frame: Day 1
Kellgren-Lawrence Classification
The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.
Time frame: Day 1
Assessment of osteophytes via ultrasonography
During osteophyte assessment, participants will be positioned in the supine position with the knee flexed approximately 30 degrees; the probe will be placed along the medial and lateral joint lines in the longitudinal and transverse planes to examine bony projections. Osteophytes will be scored according to the Outcome Measures in Rheumatology knee osteoarthritis scale criteria as small (\<2 mm - Grade 1), moderate (2-4 mm - Grade 2), and large (\>4 mm - Grade 3).
Time frame: Day 1
Assessment of synovial hypertrophy via ultrasonography
In the ultrasound assessment of synovial hypertrophy, the thickness of hypoechoic tissue in the suprapatellar region that does not shift upon probe compression will be measured, and values exceeding 2 mm will be recorded as synovial hypertrophy.
Time frame: Day 1
Assessment of synovial effusion via ultrasonography
Ultrasonographic assessment of joint effusion will be performed at the suprapatellar recess level; participants will be positioned in the supine position with the knee in near-extension or slight flexion. During the longitudinal plane examination, anechoic fluid collections will be measured, and values of 4 mm or greater will be considered pathological synovial effusions.
Time frame: Day 1
Assessment of meniscal protrusions via ultrasonography
During the ultrasound assessment of meniscus protrusion, the knee will be positioned with approximately 30 degrees of flexion, and the extent to which the meniscus tissue extends beyond the tibial margin will be evaluated in measurements taken in the longitudinal plane along the medial joint line; protrusions exceeding 3 mm will be considered pathological meniscus protrusions.
Time frame: Day 1
Ultrasonography-based measurements of quadriceps muscle thickness
For ultrasonographic measurements of quadriceps muscle thickness, participants will be positioned in the supine position with the knee extended and the muscles fully relaxed; measurements taken in the transverse plane at the midpoint between the anterior superior iliac spine and the superior pole of the patella will assess the thicknesses of the rectus femoris and vastus intermedius muscles together.
Time frame: Day 1
Ultrasonography-based measurements of quadriceps tendon thickness
Ultrasonographic measurements of the quadriceps tendon will be taken in the longitudinal plane immediately proximal to the superior pole of the patella while the knee is flexed to approximately 30 degrees, and the average of the measurements taken 5, 10, and 15 mm proximal to this point will be recorded
Time frame: Day 1
Ultrasonography-based measurements of patellar tendon thickness
Ultrasonographic assessment of the patellar tendon is performed with the knee flexed to 30 degrees, in the longitudinal plane from the apex of the patella distally, and the anteroposterior thickness is measured approximately 5 mm distal to the apex.
Time frame: Day 1
Ultrasonography-based measurements of pre-tibial and thigh subcutaneous thickness
The diagnosis of lipedema will be supported by ultrasonographic measurements of subcutaneous fat thickness in the thigh and pretibial regions. With the patient in the supine position and the lower extremities relaxed and in a neutral position, the probe is placed in the transverse plane (anterior surface of the tibia), at the midpoint between the tibial tuberosity and the medial malleolus, and on the thigh, at the midpoint along the midline between the iliac crest and the lower edge of the patella, and the total thickness of the skin and subcutaneous tissue will be measured in millimeters by applying minimal pressure. Each measurement will be taken three times, and the average will be calculated. In the literature, diagnostic threshold values have been established as a thickness measurement of \>11.7 mm in the pre-tibial region and \>17.9 mm in the thigh.
Time frame: Day 1
Plan to share: No — Individual participant data (IPD) will not be shared because the data contain
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Izmir Democracy University