Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

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.

      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.
    

Intervention name(s): Ultrasound-guided platelet-rich-plasma (PRP) injection; Ultrasound-guided dry needling
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PRP; platelet-rich-plasma; platelet; tendinosis; tendinitis; tendonitis; tendinopathy; enthesopathy; muscle; sport; tendon; patella; patellar tendon