Phase 3
N=56
Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02370420 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect) — 28.53; 22.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Platelet-Rich Plasma (Biological); rehabilitation exercises (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad Autonoma de Nuevo Leon
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect) |
28.53; 22.27 | — |
| SECONDARY Change in the SF-12 Health Survey (Quality of Life) |
41.79; 44.74 | — |
| SECONDARY Change in the Visual Analog Scale (VAS) (Global Pain) |
4.46; 3.26 | — |
Summary
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 90 years
- Patients with no previous treatment
- Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)
Exclusion Criteria
- Age 90 years
- Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic findings)
- Patients with asociated Rheumatic syndromes
- Patients with anticoagulant therapy
- Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
- Pregnant patients
- Patients with prosthetic or orthotic.
- Patients with hemoglobin values < 11g/dl , platelets < 150,000/μL
Data sourced from ClinicalTrials.gov (NCT02370420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.