ISRCTN88966184
Active, not recruiting
Phase 2
Comprehensive analysis of knee osteoarthritis treatment with microfragmented adipose tissue: A double-blinded randomized controlled trial
St Catherine Specialty Hospital0 sites80 target enrollmentAugust 1, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis
- Sponsor
- St Catherine Specialty Hospital
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with osteoarthritis of the knee who are aged 30\-75 years old
- •2\. Osteoarthritis grade 2\-3 based on Kellgren\-Lawrence classification
- •3\. Patellofemoral osteoarthritis Iwano grade 2\-3
- •4\. Presence of knee pain for at least six months
- •5\. Patients who have lower limb axis deviation less than 5°
- •6\. The possibility of following research instructions and responding to control examinations
- •7\. Signed informed consent for participation in the research
Exclusion Criteria
- •1\. Malignant diseases, systemic inflammatory diseases (e.g. rheumatoid arthritis, psoriatic arthritis) or other systemic diseases that can result in knee pain or cause systemic inflammation
- •2\. A body mass index (BMI) greater than 30 or diabetes
- •3\. Six or more painful points on the body, distributed above and below the waist, on both sides of the body and in the axilla
- •4\. Depression (determined according to the CESD\-R questionnaire)
- •5\. Stage 4 of the Kellgren\-Lawrence classification for knee osteoarthritis, stage 4 of the Iwano classification of patellofemoral arthrosis
- •6\. A MOAKS score for synovitis or effusion less than 2 (patients without knee effusion)
- •7\. Post\-traumatic osteoarthritis
- •8\. A history of surgery on the affected knee
- •9\. A deviation of the mechanical axis (valgus/varus) of the lower extremities greater than 5°
- •10\. An unstable knee
Outcomes
Primary Outcomes
Not specified
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