Osteoarthritis, Knee
Conditions
Brief summary
The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.
Interventions
BIOLOGICALPlatelet-rich plasma (PRP)
Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
BEHAVIORALViewing of preparation
The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
Sponsors
ArthroBiologix Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult men or women ages 50-80 years * Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria * Provision of informed consent
Exclusion criteria
* Patients with inflammatory osteoarthritis * Open wounds or sores over the knee joint * Patients that will likely have problems, in the judgement of the investigators, with maintaining follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain | 12 weeks | Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | 12 weeks | Range of motion in the knee from full extension to full flexion. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12 weeks | Patient reported knee osteoarthritis index with subscores of pain, function and stiffness. The range of scores on the WOMAC is from 0-96, with higher scores indicating worse outcomes. The subscore of pain is on a scale of 0-20, the subscore of stiffness is 0-8, and the subscale of function is 0-68. The scores of the subscales are summed in order to get the total score. |
| Short Form 12 (SF-12) Functional outcome assessment | 12 weeks | Health-related quality of life measure on a scale from 0-100, where higher scores indicate better function. |
Countries
Canada
Outcome results
None listed