Evaluation of the Effect of Biofiller PRP Application on Range of Motion, Pain, Quality of Life and Femoral Cartilage Thickness in Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Study Overview
Brief Summary
The aim of this study is to evaluate the effects of biofiller PRP, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.
Detailed Description
Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1-45-65 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
Exclusion Criteria
- •1 - History of surgery or traumatic injury 2-Inflammatory arthritis 3-History of cancer, bleeding diathesis and psychiatric disease 4-Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-Hip and ankle problems 6-Participating in another physical therapy program in the last 3 months 7-History of intra-articular injections in the last 6 months
Arms & Interventions
Platelet rich plasma
Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe
Intervention: biofiller prp (Other)
Biofiller platelet rich plasma
Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe. PRP was incubated in hot incubator at 75 °C for 10 min and then cooled in a refrigerator for 5 min.
Intervention: biofiller prp (Other)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Time Frame: Baseline and month 3
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Secondary Outcomes
- Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month(Baseline and month 3)
- Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3(Baseline and month 3)
Investigators
Banu Ordahan
professor
Necmettin Erbakan University