AzTrials
AzTrials

LipedemaNCT07575555

The Effect of Lipedema on Knee Osteoarthritis

An observational study of Lipedema and Knee Osteoarthritis, run by Izmir Democracy University at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 65 years, women only
How many people
76 participants
Where
2 sitesTurkey (Türkiye)
Study dates
7 Jul 2026to 15 Aug 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 30 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • All participants (Group 1 + Group 2)
  • Women aged 30-65
  • With a clinical and radiological diagnosis of knee osteoarthritis
  • Who agreed to participate in the study
  • Group 1 (knee osteoarthritis with lipedema):
  • Patients who meet the Wold criteria for a clinical diagnosis of lipedema
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  • An increase in subcutaneous fat thickness confirmed by ultrasound
  • Group 2 (knee osteoarthritis without lipedema):
  • No diagnosis of lipedema

Who cannot join

  • Inflammatory arthritis
  • History of knee surgery
  • Intra-articular injection within the past 6 months
  • Acute trauma
  • Systemic connective tissue disease
  • Severe venous insufficiency or lymphedema
Show all 11Show fewer
  • History of malignancy
  • Use of gabapentinoids/SNRIs/SSRIs due to fibromyalgia or psychiatric illness
  • Severe cognitive impairment or communication problems that would prevent participation in the study
  • Pregnancy
  • Participants who were informed about the study and refused to participate

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kadir Songür, Assoc. Prof. contact

+905054529231

kadir.93@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Izmir Democracy University

    Izmir, İzmir, 35570

    Kadir Songür, +905054529231, kadir.93@gmail.com

    Not yet recruiting
  • Izmir Democracy University

    Izmir, İzmir, 35570

    Kadir Songür, 05054529231, kadir.93@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Lipedema on Knee Osteoarthritis: A Cross-Sectional Analysis of Clinical Symptoms and Ultrasonographic Findings

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.

Keywords
lipedema, knee osteoarthritis, knee joint, knee
Medical subject headings
Lipedema, Osteoarthritis, Knee, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07575555
Study groupRoleWhat they receive
Group 1Knee osteoarthritis with lipedema
Group 2Knee osteoarthritis without lipedema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

Secondary outcomes (11)
  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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. Kellgren-Lawrence Classification

    The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.

    Measured: Day 1

  5. 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).

    Measured: Day 1

  6. 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.

    Measured: Day 1

  7. 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.

    Measured: Day 1

  8. 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.

    Measured: Day 1

  9. 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.

    Measured: Day 1

  10. 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

    Measured: Day 1

  11. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start7 Jul 2026
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
76 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575555
Sponsor's protocol ID
2026/26
Status last verified
Jul 2026
First submitted
3 May 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the data contain

Questions about this trial

What is this clinical trial studying?

An observational study of Lipedema and Knee Osteoarthritis, run by Izmir Democracy University at 2 sites 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kadir Songür, Assoc. Prof. (+905054529231, kadir.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonography-based measurements of femoral cartilage thickness (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Jul 2026.

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