Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

BACKGROUND: Although initial studies have demonstrated that concentrated bone marrow aspirate (cBMA) injections promote rotator cuff repair (RCR) healing, there are no randomized prospective studies investigating clinical efficacy. HYPOTHESIS/PURPOSE: To compare outcomes after arthroscopic RCR (aRCR) with and without cBMA augmentation. It was hypothesized that cBMA augmentation would result in statistically significant improvements in clinical outcomes and rotator cuff structural integrity. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients indicated for aRCR of isolated 1- to 3-cm supraspinatus tendon tears were randomized to receive adjunctive cBMA injection or sham incision. Bone marrow was aspirated from the iliac crest, concentrated using a commercially available system, and injected at the aRCR site after repair. Patients were assessed preoperatively and serially until 2 years postoperatively via the following functional indices: American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test, 12-Item Short Form Health Survey, and Veterans RAND 12-Item Health Survey. Magnetic resonance imaging (MRI) was performed at 1 year to assess rotator cuff structural integrity according to Sugaya classification. Treatment failure was defined as decreased 1- or 2-year ASES or SANE scores as compared with preoperative baseline, the need for revision RCR, or conversion to total shoulder arthroplasty. RESULTS: An overall 91 patients were enrolled (control, n = 45; cBMA, n = 46): 82 (90%) completed 2-year clinical follow-up and 75 (82%) completed 1-year MRI. Functional indices significantly improved in both groups by 6 months and were sustained at 1 and 2 years (all P < .05). The control group showed significantly greater evidence of rotator cuff retear according to Sugaya classification on 1-year MRI (57% vs 18%; P < .001). Treatment failed for 7 patients in each group (control, 16%; cBMA, 15%). CONCLUSION: cBMA-augmented aRCR of isolated supraspinatus tendon tears may result in a structurally superior repair but largely fails to significantly improve treatment failure rates and patient-reported clinical outcomes when compared with aRCR alone. Additional study is warranted to investigate the long-term benefits of improved repair quality on clinical outcomes and repair failure rates. REGISTRATION: NCT02484950 (ClinicalTrials.gov identifier).

Neoadjuvant radiation influences the pseudocapsule in soft tissue sarcoma: A histopathologic and radiographic evaluation.

BACKGROUND AND OBJECTIVES: A pseudocapsule surrounds soft tissue sarcoma (STS). Its composition, response to neoadjuvant radiation, and clinical significance are poorly understood. METHODS: Seventeen cases of high-grade undifferentiated pleomorphic sarcoma (UPS) were reviewed, ten of which were treated with neoadjuvant radiation. Magnetic resonance imaging (MRI) studies, pathology slides, and patient records were reviewed. RESULTS: Irradiated pseudocapsules were well-demarcated with fewer viable tumor cells and were thicker on both pathology and MRI measurements when compared to non-irradiated pseudocapsules (p < 0.001, p = 0.04, respectively). Pseudocapsule mean pathology width (MPW) was positively correlated with tumor necrosis percentage (p = 0.044), and negatively correlated with mitotic rate (p = 0.043), though pseudocapsule width measured on MRI did not correlate with these prognostic factors. Despite an evident treatment response to neoadjuvant radiation, viable tumor cells were present within the pseudocapsule and the surrounding healthy tissue. CONCLUSIONS: The pseudocapsule in STS responds to radiation and there appears to be a correlation between pseudocapsule width and tumor necrosis and mitotic activity. As viable tumor cells are present beyond the pseudocapsule, surgeons should remain cautious in determining margins of resection in STS when using the pseudocapsule as a palpable landmark. This novel study is the most detailed to date to describe the histopathologic and radiographic characteristics of the STS pseudocapsule. Further studies are needed to determine the clinical significance of the pseudocapsule.