Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
2 other identifiers
interventional
30
1 country
2
Brief Summary
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedMarch 29, 2019
March 1, 2019
9.6 years
July 28, 2011
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-reported improvement in symptoms at 12 weeks
12 weeks
Secondary Outcomes (1)
Reduction in patellar tendinosis by MRI
6 months
Study Arms (2)
Dry needling
SHAM COMPARATORBlood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.
Platelet-rich plasma (PRP)
EXPERIMENTALBlood will be drawn, and platelet-rich plasma will be injected into the tendon.
Interventions
Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.
Eligibility Criteria
You may qualify if:
- Acute or chronic ligament or tendon injuries
You may not qualify if:
- Pregnant women,
- children,
- other injuries that require surgical intervention,
- associated fractures,
- systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- NYU Langone Healthcollaborator
Study Sites (2)
Stanford University School of Medicine
Stanford, California, 94305, United States
New York University Langone Orthopedic Hospital
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Christina Herrero
New York University Langone Orthopedic Hospital
- PRINCIPAL INVESTIGATOR
Dr. Jason L. Dragoo
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
August 1, 2009
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share