N/A
N=75
Comparison of Acetaminophen and PRP Therapy for Knee OA
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01782885 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) — 3.0; 2.9; 8.0; 7.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intra-articular injection of PRP (Procedure); Acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
1.9; 0.8; 5.3; 2.9; 16.7; 7.9 | — |
| PRIMARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
1.9; 0.8; 5.3; 2.9; 16.7; 7.9 | — |
| PRIMARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
1.9; 0.8; 5.3; 2.9; 16.7; 7.9 | — |
| PRIMARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
1.9; 0.8; 5.3; 2.9; 16.7; 7.9 | — |
| SECONDARY Change in Visual Analog Scale (VAS) |
5.9; 4.9; 3.8; 1.9; 4.1; 1.9 | — |
Summary
The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular injection therapy is effective as an alternative treatment option in patients with mild knee osteoarthritis within a controlled randomized study compared to first line treatment acetaminophen. The investigators will evaluate patients outcome in level of pain, knee function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.
The study will be complemented with in vitro experiments of human osteoarthritic cartilage explants culture (treated with PRP) for histological and gene expression assays.
PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis by modifying the biochemical joint environment and cartilage regeneration capability.
Eligibility Criteria
Inclusion Criteria
- Older than 18 years old
- Patients who haven't received steroids injection or medical treatment 1 month before the study
- Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
- Indistinct gender
- Patients who accept to participate in the study with previous signed informed consent
Exclusion Criteria
- Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
- Patients with prosthesis
- Pregnancy
- Patients with rheumatic diseases
- Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections
- Patients taking anticoagulants
- Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL
Data sourced from ClinicalTrials.gov (NCT01782885). 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.