Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Patient-reported improvement in symptoms at 12 weeks
Study Overview
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.
Detailed Description
Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.
Patients will be randomized and blinded to a treatment regimen.
Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.
To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.
Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute or chronic ligament or tendon injuries
Exclusion Criteria
- •Pregnant women,
- •children,
- •other injuries that require surgical intervention,
- •associated fractures,
- •systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues
Arms & Interventions
Dry needling
Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.
Intervention: Ultrasound-guided dry needling (Procedure)
Platelet-rich plasma (PRP)
Blood will be drawn, and platelet-rich plasma will be injected into the tendon.
Intervention: Ultrasound-guided platelet-rich-plasma (PRP) injection (Procedure)
Outcomes
Primary Outcomes
Patient-reported improvement in symptoms at 12 weeks
Time Frame: 12 weeks
Secondary Outcomes
- Reduction in patellar tendinosis by MRI(6 months)
Investigators
Jason L. Dragoo
Associate Professor
Stanford University