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    Investigating a Novel Biologic to Enhance Rotator Cuff Repair

    A randomized controlled trial compared healing rates in arthroscopic double-row rotator cuff repair with and without the use of leucocyte- and platelet-rich fibrin.

    Authors

    Timothy G. Reish, MD, and Russell M. Odono, MD

    Article

    Zumstein MA, Rumian A, Thelu CE, Lesbats V, O’Shea K, Schaer M, Boileau P. SECEC Research Grant 2008 II: Use of platelet- and leucocyte-rich fibrin (L-PRF) does not affect late rotator cuff tendon healing: a prospective randomized controlled study. J Shoulder Elbow Surg, 2016 Jan;25(1):2-11. doi:0.1016/j.jse.2015.09.018.

    Summary

    In this prospective, randomized, controlled study, Zumstein et al compared arthroscopic double-row rotator cuff repair with and without leucocyte- and platelet-rich fibrin (L-PRF) at a mean 14 months of follow-up (range, 12-25 months):

    • 17 patients received arthroscopic rotator cuff repair with L-PRF locally applied to the repair site (L-PRF+ group)
    • 18 patients received arthroscopic rotator cuff repair without L-PRF (L-PRF- group)

    Preoperative and postoperative clinical evaluations included the Subjective Shoulder Value, Visual Analog Score for pain, Simple Shoulder Test, and Constant-Murley scores. Magnetic resonance arthrography (MRA) was performed in all patients at 12 months of follow-up to assess for an anatomic watertight healing, tendon thickness, and tendon quality.

    Both groups showed clinical improvement after surgery, with no significant clinical differences detected with the Subjective Shoulder Value, Simple Shoulder Test, and Constant-Murley scores.

    At the 12-month follow-up, an anatomic watertight healing was found in 11/17 patients in the L-PRF+ group and in 11/18 in the L-PRP- group. The mean postoperative defect size and tendon quality were similar in both groups.

    Application of L-PRF during arthroscopic rotator cuff repair provided no beneficial effect in clinical outcome, anatomic healing rate, mean postoperative defect size, and tendon quality when compared with no application of L-PRF at 12 months of follow-up.

    Clinical Relevance

    The incidence of failed tendon healing after rotator cuff repair is variable and has been reported in up to 94% of patients by Galatz et al.

    Patients over age 65 years continue to be a particularly difficult cohort of patients, with significant rates of failure after attempted rotator cuff repair. Thus, biologic augmentation is an appealing option for reducing failure rates.

    The study by Zumstein et al examined chronic rotator cuff tears in a cohort of patients with a mean age of 65.3 years (range, 57-74 years). In patients like these, we have attempted to find biologic options to repair a diseased tendon that has decreased vascularization in order to improve the healing rate of tendon to bone.

    Unfortunately, studies of healing rates following implementation of various bioactive augmentation materials – including leucocyte- and platelet-rich plasma, leucocyte-poor or pure platelet-rich fibrin, and gene therapy stem cell application – have shown little difference when compared with healing rates for traditional arthroscopic rotator cuff repair.

    L-PRF is a novel augmentation scaffold that has the benefit of growth factor delivery without rapid dissolution rates, thus providing a sustained release of growth factors for weeks after surgery. In a previous study by the same group, increased neovascularization was reported with this same technique, which, theoretically, shows the potential of L-PRF in the healing at the bone-tendon interface.

    In the current climate, costs, efficiency, quality, and outcomes measures must all be taken into account when determining the best treatment modality for patients. As demonstrated in this study, the addition of L-PRF added cost, complexity, and increased surgical time (on average, 26 minutes per case) in this cohort of patients, who were all surgically repaired by an experienced surgeon. In addition, at 12-month follow-up, postoperative MRI showed significantly greater fatty infiltration of the supraspinatus in the L-PRF+ group.

    Secondary to high rates of failure after rotator cuff repair, biologic augmentation techniques are intriguing and promising options. However, these additions must be considered cautiously, as evidence of clinical improvement is sparse.

    This was a novel, well-done prospective, randomized, blinded study that attempted to detect a difference in the healing rates and tendon quality of repaired rotator cuff tissue with the augmentation of L-PRF compared with modern-day arthroscopic double-row rotator cuff repair. With our increasing knowledge of the biology and multiple variables behind the healing of tendon to bone, the field of biologic augmentation with respect to the bone-tendon interface will continue to expand.

    Although this trial did not show improvement in the healing of tendon to bone with the addition of L-PRF, it provides a well-done template with which further studies can be constructed to better understand the vast array of options that will become available to help surgeons promote improved clinical results and optimized patient care.

    Author Information

    Timothy G. Reish, MD, is a Clinical Assistant Professor, Division of Sports Medicine, Department of Orthopaedic Surgery, NYU Langone Medical Center – Hospital for Joint Diseases, New York, New York. Russell M. Odono, MD, is Adult Reconstruction Fellow, Department of Orthopaedic Surgery, Insall Scott Kelly Institute/NYU Langone Medical Center – Hospital for Joint Diseases, New York, New York.