The Effect of Lipedema on Knee Osteoarthritis
1 other identifier
observational
76
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
Study Completion
Last participant's last visit for all outcomes
August 15, 2027
May 8, 2026
May 1, 2026
1 year
May 3, 2026
May 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 1
Secondary Outcomes (11)
Western Ontario and McMaster Universities (WOMAC) score
Day 1
Visual analog scale
Day 1
Joint Range of Motion measurement
Day 1
Kellgren-Lawrence Classification
Day 1
Assessment of osteophytes via ultrasonography
Day 1
- +6 more secondary outcomes
Other Outcomes (1)
Ultrasonography-based measurements of pre-tibial and thigh subcutaneous thickness
Day 1
Study Arms (2)
Group 1
Knee osteoarthritis with lipedema
Group 2
Knee osteoarthritis without lipedema
Eligibility Criteria
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.
You may qualify if:
- 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
- An increase in subcutaneous fat thickness confirmed by ultrasound
- Group 2 (knee osteoarthritis without lipedema):
- No diagnosis of lipedema
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Democracy University
Izmir, İzmir, 35570, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Lecturer
Study Record Dates
First Submitted
May 3, 2026
First Posted
May 8, 2026
Study Start (Estimated)
July 15, 2026
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
August 15, 2027
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because the data contain