NCT07575555

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

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

lipedemaknee osteoarthritisknee jointknee

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

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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)

Location

MeSH Terms

Conditions

LipedemaOsteoarthritis, KneeChronic Pain

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kadir Songür, Assoc. Prof.

CONTACT

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

Locations