Platelet Rich Plasma on Rotator Cuff Repair
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical
      results. Several ways to improve the healing tendon-bone are currently studied, among them
      the most used is the use of growth factors. The platelet-rich plasma is a source of several
      growth factors, and is already used in various orthopedic procedures. The aim of this study
      is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in
      arthroscopic rotator cuff repairs.
    

Detailed description: 
      Rotator cuff repair(RCR) is a procedure widely performed in the shoulder surgery, given the
      high prevalence of this type of injury in the population. Regardless of the approach
      employed, the procedure consists of the rehabilitation of the rotator cuff to his bed.
      Despite the clinical results are highly satisfactory (success rate around 85%), studies using
      ultrasound and magnetic resonance imaging (MRI) showed a rate of re-rupture after surgery 20
      to 54%. These levels of re-injury suggest a sub-optimal healing in the bone-tendon interface.

      Attempts to improve the healing in place of the RMR has been extensively studied in the
      orthopedic literature. One is the use of growth factors (GF), cytokines play an important
      role in chemotaxis, cell proliferation and differentiation, as well as the synthesis of
      extracellular matrix, and that theoretically could have beneficial role in tissue repair.

      The Platelet-Rich Plasma (PRP) is one of the most studied sources of GF. It is easy to
      prepare and non-immunogenic (is done with the patient's own blood), and has the further
      advantage of the presence of several FC (including PDGF, bFGF, TGF-B, VEGF, EGF, CTGF and
      IGF). This fact is important because the disease have different effects on different
      receivers during the various stages of healing.

      The use of PRP in bone healing has been evaluated in several studies with conflicting
      results. There are preclinical studies demonstrating the beneficial effect of PRP on tendon
      and ligament repair. However, there is no published papers showing the effectiveness of the
      use of PRP on tendon-bone interface.

      The aim of this study is to evaluate the effectiveness of PRP in enhancing the healing
      tendon-bone repair after injury of RC.

      Will be operated patients with complete injury (full thickness) of the rotator cuff, divided
      into two groups randomly. The use of PRP or not will be decided by sealed envelopes, with 20
      individuals in each group. The subjects will be assessed pre and postoperatively according to
      the criteria for the Constant and UCLA and with the help of MRI, being unknown to the
      evaluators to which group the patient belongs.
    

Intervention name(s): Platelet rich plasma
Intervention type(s): Other
Intervention description(s): Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotator cuff lesions; Platelet rich plasma; Arthroscopic repair