Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The goal of this study is to assess whether undergoing surgical repair of the rotator cuff
      with the additional intervention of whole blood fibrin clot will improve rotator cuff
      vascularization at the bone-tendon interface repair site and patient outcomes compared to
      those who do not receive the whole blood fibrin clot intervention.
    

Detailed description: 
      Patient outcomes after rotator cuff repair vary greatly and depend on the size of the tear
      itself. Researchers have identified a number of devices that can be used to reinforce the
      surgical repair and enhance the structure and function of both the muscles and tendons (Jo et
      al., 2011; Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011; Proctor, 2014).
      Reinforcement patches have been used to help improve surgical outcomes, including: allograft
      rotator cuff, human cadaveric skin, pig and bovine skin, equine pericardium, and porcine
      intestinal submucosa (Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011). Although
      synthetic patches have also shown some effectiveness, these patches do not provide biologic
      augmentation of the tendon repair (Jo et al., 2011).

      Additionally, there has been some research examining the effectiveness of using platelet-rich
      plasma therapy to help repair both rotator cuff tendinopathy and tears. Platelets play an
      important role in the healing process and it has been theorized that exposing inflamed or
      healing tissue to higher densities of platelets can contribute to less pain, better range of
      motion (ROM), and overall healing (Pandey et al., 2016). The consensus on this type of
      therapy has shown inconclusive results, however. For example, research by Jo et al. (2011)
      found no significant change in clinical recovery in respect to pain or ROM compared to a
      control group. Alternatively, Pandey et al. (2016) found significant improvements in both
      pain and ROM scores as well as decreased re-tear rates in the plasma-rich protein treatment
      group. These and other similar studies utilized different methodologies for patient
      populations (tendinopathy versus full tears, etc.), treatment timing, formulation of
      platelet-rich plasma or whole blood fibrin clot, and time of follow-up. Further research is
      needed to identify what treatments, if any, in the field of platelet-rich plasma are most
      beneficial for patients with rotator cuff tears. Recent research has demonstrated that whole
      blood fibrin clots concentrate 98% of available platelets and release growth factors
      including vascular endothelial growth factor over two weeks (Siegel, Clevenger, Proctor,
      Clegg, & Proctor, 2017). However, clinical evidence indicating the effect of whole blood
      fibrin clots on the healing of repaired torn rotator cuffs is lacking (Jo et al., 2011). The
      goal of this study is to assess whether undergoing surgical repair of the rotator cuff with
      the additional intervention of whole blood fibrin clot will improve rotator cuff
      vascularization at the bone-tendon interface repair site and patient outcomes compared to
      those who do not receive the whole blood fibrin clot intervention.
    

Intervention name(s): Whole Blood Fibrin Clot
Intervention type(s): Other
Intervention description(s): For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Rotator cuff repair, whole blood fibrin clot