Osteoarthritis, Knee
Conditions
Brief summary
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.
Interventions
PROCEDUREIntra-articular Stromal Vascular Fraction Injection
Adipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions.
Sponsors
Shu-Hao Chang, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 35 years. * Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2\ 4. * Persistent knee pain after nonsurgical treatment.
Exclusion criteria
* Arthritis caused by other systemic or local immune diseases. * Patients who have undergone total knee replacement surgery. * Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months. * Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain. * Patients with severe heart problems and coagulation disorders. * Patients who have taken glucosamine within the previous month. * MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline and at 3 and 6 months post-intervention | range from 0-96, with higher scores indicating greater OA-related disability |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline and at 3 and 6 months post-intervention | 5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA |
| Visual Analogue Scale (VAS) | Baseline and at 3 and 6 months post-intervention | range from 0-10, with higher scores indicating increased degree of pain |
| Magnetic resonance imaging (MRI) | Baseline and 6 months after the intervention | included T2 mapping |
Countries
Taiwan
Outcome results
None listed