Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma

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.

Post injection activity: All patients will use crutches for 24-48 hours after injection. All
patients will have physical therapy two times a week according to a standardized protocol.

Follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. All patients
will fill out an injury location specific questionnaire, Tegner Activity Scale, short
form-12, and visual analog scale for pain, among others. Additional follow-up will be done at
6 months, 1 year and 2 years. All radiographic studies will be read by a radiologist blinded
to the study groups.

The primary endpoint for all patients in the study will be twelve weeks. Secondary enpoints
are 6 months, 1 year and 2 years.

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