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

Abstract

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).

Bone Marrow Aspirate Concentrate Harvest Techniques for the Sports Medicine Surgeon

“… 12 In the shoulder, randomized trial data exist suggesting those having rotator cuff repairs augmented with BMAC have lower retear rates on magnetic resonance imaging at 1-year postoperatively. 13 For the hip, those with symptomatic labral tears with early degenerative radiographic changes may perform similarly to those without arthritis, if they have intra-articular injection of iliac-crest derived BMAC. 14 Furthermore, those with full-thickness acetabular chondral flaps have better outcome scores after treatment with BMAC as opposed to microfracture.…”

Translational Research on Orthobiologics in the Treatment of Rotator Cuff Disease: From the Laboratory to the Operating Room

“…24 The mean number of MSCs administered was 51,000 ± 25,000 and the patients with fewer MSCs administered had lower rates of intact repairs at long-term follow-up. 24 More recently, Cole et al 25 performed a single-blinded RCT of 91 patients undergoing arthroscopic RCR with and without BMAC augmentation and found higher rates of failed healing in the control group compared with the BMAC group on MRI at 1 year postoperatively (57% vs 18%, P < 0.001). Although these studies demonstrate promising results, there is still an absence of thorough characterization of CTPs in the clinical literature, and more research is needed to correlate the clinical outcome measures with the composition and biological activity of the cells administered.…”

Cell-Based Therapies for Rotator Cuff Injuries: An Updated Review of the Literature

“…Overall, our review found 18 case reports/series, RCTs, and case control series examining the effects of MSCs of rotator cuff tears (see Table 1 ) [ 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 ]. The most notable features of each study are summarized in Table 1 .…”