PRP in ACLR to Prevent PTOA
Recruiting
Phase 3
Interventional Study
Anterior Cruciate Ligament Injuries
Post-traumatic Osteoarthritis
PRP
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 – 50
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 56 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
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About This Trial
The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Acute ACL injury within 6 weeks of presentation
* Age 14-50
* Male or female
* Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)
Exclusion Criteria:
* Prior ACL reconstruction
* Prior cartilage repair proc…
Contacts