Phase 2
N=24
Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
Anterior Cruciate Ligament Tear · Anterior Cruciate Ligament Rupture
Bottom Line
View on ClinicalTrials.gov: NCT04088227 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration — 13.8; 16; 9.9; 7.5 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Experimental Group (Drug); Control Group (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Andrews Research & Education Foundation
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration |
13.8; 16; 9.9; 7.5; 53.1; 64.3 | — |
Summary
A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis.
The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.
Eligibility Criteria
Inclusion Criteria
- No history of previous traumatic ipsilateral knee injury
- Bone bruise visualized on MRI
- No clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury
Exclusion Criteria
- Patients without a palpable knee effusion
- An injury occurring more than 10 days before enrollment
- Previous ipsilateral knee surgery
- Intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury
- Participation in another clinical drug trial within the 4 weeks before injury
- A history of any inflammatory disease or immune-comprised
Data sourced from ClinicalTrials.gov (NCT04088227). 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.