Augmentation Of Rotator Cuff Repair Research Articles

Biologic Augmentation of Rotator Cuff Repair: Current Concepts Review.

Rotator cuff tears are common in an aging population. Thus far, primary repairs have shown high re-tear rates suggesting the need for improved healing modalities. Current augmentations of rotator cuff repairs include synthetic and biological scaffolds, surgical bone marrow venting, and infusing the repair with a variety of stem cells and growth factors aimed at restoring the native cellular structure and function of the repaired tissue. This current concepts review discusses the anatomy, physical presentation, diagnosis, and treatment of rotator cuff tears; biological adjuvants for rotator cuff repairs; and the current literature on outcomes after biologically augmented rotator cuff repairs. [Orthopedics. 202x;4x(x):xx-xx.].

Engineered Tendon-Fibrocartilage-Bone Composite With Mechanical Stimulation for Augmentation of Rotator Cuff Repair: A Study Using an In Vivo Canine Model With a 6-Month Follow-up

Background: Rotator cuff repair augmentation using biological materials has become popular in clinical practice to reduce the high retear rates associated with traditional repair techniques. Tissue engineering approaches, such as engineered tendon-fibrocartilage-bone composite (TFBC), have shown promise in enhancing the biological healing of rotator cuff tears in animals. However, previous studies have provided limited long-term data on TFBC repair outcomes. The effect of mechanical stimulation on TFBC has not been explored extensively. Purpose: To evaluate functional outcomes after rotator cuff repair with engineered TFBC subjected to mechanical stimulation in a 6-month follow-up using a canine in vivo model. Study Design: Controlled laboratory study. Methods: A total of 40 canines with an acute infraspinatus (ISP) tendon transection model were randomly allocated to 4 groups (n =10): (1) unilateral ISP tendon undergoing suture repair only (control surgery); (2) augmentation with engineered TFBC alone (TFBC); (3) augmentation with engineered TFBC and bone marrow-derived stem cells (BMSCs) (TFBC+C); and (4) augmentation with engineered TFBC and BMSCs, as well as mechanical stimulation (TFBC+C+M). Outcome measures—including biomechanical evaluations such as failure strength, stiffness, failure mode, gross appearance, ISP tendon and muscle morphological assessment, and histological analysis—were performed 6 months after surgery. Results: As shown in the mechanical test, the TFBC+C+M group exhibited higher failure strength compared with other repair techniques. The most common failure mode was avulsion fracture in the TFBC+C+M group, but tendon-bone junction rupture was observed predominantly in different groups. Engineered TFBC with mechanical stimulation showed over 70% relative failure strength compared with normal ISP, and the other groups showed about 50% relative failure strength. Histological analysis revealed less fat infiltration and closer-to-normal muscle fiber structure in the mechanical stimulation group. Conclusion: This study provides evidence that mechanical stimulation of engineered TFBC promotes rotator cuff regeneration, thus supporting its potential for rotator cuff repair augmentation. Clinical Relevance: This study provides valuable evidence supporting the use of a novel tissue-engineered material (TFBC) in rotator cuff repair and paves the way for advancements in the field of rotator cuff regeneration.

Restoring the Anteroposterior Shoulder Force Couple: Arthroscopic-Assisted Lower Trapezius Tendon Transfer With Partially Augmented Rotator Cuff Repair for Irreparable Massive Rotator Cuff Tears

Lower trapezius transfer presents a highly encouraging therapeutic approach for addressing posterosuperior irreparable massive rotator cuff tears. Based on studies on the balance of force couples of the rotator cuff, more scholars believe that attention should be paid to the reconstruction of the force couples of the rotator cuff. This study proposes a modified surgical approach that integrates an arthroscopic-assisted lower trapezius transfer with autologous hamstring tendon and partially augmented rotator cuff repair for irreparable massive rotator cuff tears, with a focus on restoring the anterior-posterior shoulder force couple.

Biologic augmentation of rotator cuff repair with microfragmented autologous subacromial bursal tissue enveloped in a patch of compressed autologous long head of biceps tendon tissue: the Bio-Ravioli technique

Rotator cuff repair is one of the most frequently performed procedures in orthopedic surgery. However, considering the limited healing potential of rotator cuff tendons, several augmentation strategies have evolved to enhance tendon healing. The purpose of this article was to present a new surgical technique called Bio-Ravioli. Patients with repairable full-thickness posterosuperior rotator cuff tear and a moderate-to-high risk of healing failure were chosen as candidates for the Bio-Ravioli procedure. It is a biologic augmentation strategy to increase healing potential of arthroscopic rotator cuff repair by use of a biologic graft fixed at the bone-tendon interface. The Bio-Ravioli consists of microfragmented autologous subacromial bursal tissue enveloped in a patch of compressed autologous long head of biceps tendon tissue. The rotator cuff is then repaired to the bone and over the graft using a transosseus equivalent configuration. The Bio-Ravioli technique represents an easy and reliable way to increase the healing potential at the bone-tendon interface by using autologous mesenchymal stem cells from different sources: subacromial bursa and long head of the biceps tendon.

Ultrasound and patient-reported outcomes of rotator cuff repair with new acellular human allograft at 6 months and 1 year post surgery

PurposeDetermine the effect of a novel acellular cannulated dermal allograft, on tendon-to-bone healing, retear rates, and clinical outcomes over a 12-month period. MethodsThis was a single surgeon prospective non-randomized case series. Patients with medium sized full-thickness superior and posterosuperior rotator cuff tears, as confirmed by magnetic resonance imaging (MRI), were consented. Patients were excluded if they had fatty atrophy indicative of Goutallier grade III or IV. The allograft is a cannulated rectangular prism that has a 5-year shelf life, does not require prehydration, and does not need to be trimmed to size. Outcome metrics included ultrasound (US) assessment at 1 year as well as 6 month patient reported outcomes scores. Results31 patients consented and enrolled in this consecutive cohort series. 9 patients were excluded and statistical analysis was performed on the remaining 22 patients. There were 9 females and 13 males. The average age was 59.27 ± 7.48 years old. The average supraspinatus short axis measurement in males was 0.56 ± 0.12 cm and 0.52 ± 0.09 cm in females (p=0.44). The average supraspinatus long axis measurement in males was 0.61 ± 0.18 cm and 0.55 ± 0.14 cm in females (p=0.46). The average infraspinatus short axis measurement in males was 0.48 ± 0.10 cm and 0.50 ± 0.13 in females (p=0.74). The average infraspinatus long axis measurement in males was 0.44 ± 0.12 cm and 0.43 ± 0.08 cm in females (p=0.84). Of the 19 patients who completed baseline and 6 month PRO’s, 17 achieved the MCID for ASES and PROMIS UE 7a. Retear occurred in 2 cases. The remaining 20 cases have all demonstrated healing or fully healed repairs at their most recent clinic visits with no additional cases of retears. ConclusionThis study is the first to report the results of a novel acellular dermal allograft for Rotator Cuff Repair Augmentation. Satisfactory patient-reported outcome measures and robust tendon healing at 1 year as measured by ultrasound demonstrate the utility of a cannulated human acellular dermal allograft as a viable biologic augmentation device for Rotator Cuff repair.

TENDON BIOENGINEERING: CHALLENGES FOR CLINICAL APPLICATION

Tendons mainly consist of collagen in order to withstand high tensile forces. Compared to other, high turnover tissues, cellularity and vascularity in tendons are low. Thus, the natural healing process of tendons takes long and can be problematic. In case of injury to the enthesis, the special transition from tendon over cartilage to bone is replaced by a fibrous scar tissue, which remains an unsolved problem in rotator cuff repair.To improve tendon healing, many different approaches have been described using scaffolds, stem cells, cytokines, blood products, gene therapy and others. Despite promising in vitro and in vivo results, translation to patient care is challenging. In clinics however, tendon auto- or allografts remain still first choice to augment tendon healing if needed.Therefore, it is important to understand natural tendon properties and natural tendon healing first. Like in other tissues, senescence of tenocytes seems to play an important role for tendon degeneration which is interestingly not age depended. Our in vivo healing studies have shown improved and accelerated healing by adding collagen type I, which is now used in clinics, for example for augmentation of rotator cuff repair. Certain cytokines, cells and scaffolds may further improve tendon healing but are not yet used routinely, mainly due to missing clinical data, regulatory issues and costs.In conclusion, the correct diagnosis and correct first line treatment of tendon injuries are important to avoid the necessity to biologically augment tendon healing. However, strategies to improve and accelerate tendon healing are still desirable. New treatment opportunities may arise with further advances in tendon engineering in the future.

Augmentation of Rotator Cuff Repair Using Umbilical Cord Graft: A Preliminary Observational Study.

Due to the high rate of rotator cuff re-tear there is an extensive research on augmentation of rotator cuff repairs. The purpose of this single center, prospective study was to evaluate the results of augmentation of the rotator cuff repair with an umbilical cord allograft. The graft group in which the rotator cuff repair was augmented with the graft as an on-lay patch was consisted of 14 patients, while the control group was consisted of 10 patients. The primary outcome of the study was incidence of rotator cuff retears, while secondary outcomes included functional and pain scores. At 6 mo there was a significantly higher incidence of retears in the control group (30%) compared to the graft group (0%; P = 0.028), while at 12 mo the retear rates were statistically similar for the two groups (P = 0.46). The Constant-Murley scores, the ASES scores and the VAS score were similar (P > 0.05) for the two groups at all study times. The results of the study indicated that augmentation of the cuff repair with human umbilical cord graft can result in similar patient reported outcomes compared to a cuff repair without augmentation, but with a lower re-tear rate at 6 mo.

Biomechanical comparison of suture bridge rotator cuff repair with and without dermal allograft pledgets

BackgroundOne method to augment rotator cuff repair is to pass dermal allograft pledgets along the sutures that bridge from the medial to the lateral row. It remains unclear whether this augmentation method alters repair biomechanics. MethodsThis was a controlled laboratory study. After an a priori power analysis, nine pairs of rotator cuffs underwent double row suture bridge rotator cuff repair, half randomized to augmentation with dermal allograft pledgets passed along the suture bridge sutures. Repairs were then mounted on a material testing system and loaded cyclically 500 cycles to mesure applied force and displacement. Repairs then underwent ultimate failure testing and stiffness, ultimate failure force, and ultimate failure displacement were measured. Paired t-tests were performed to compare between groups. ResultsThere were no differences between groups in construct gapping with cyclic loading after 500 cycles (p = 0.885). There no differences between the augmented and control groups in yield force (103.5 ± 5.0 vs. 101.4 ± 5.9 N, respectively, p=0.183), stiffness (94.2 ± 13.9 vs. 90.9 ± 13.8, p=0.585), or ultimate failure force (255.3 ± 65.8 vs. 285.3 ± 83.2, p=0.315). There were no differences between groups in failure modes, with most specimens failing by cuff tissue tearing within or medial to the construct. ConclusionThe addition of dermal allograft pledgets does not positively or negatively influence the time-zero biomechanical characteristics of double-row suture bridge rotator cuff repair.

Indications and Technique: Rotator Cuff Repair Augmentation.

Rotator cuff repair (RCR) augmentation is often considered for patients with large-to-massive rotator cuff tears or chronic tears with poor tissue quality. Augmentation can provide mechanical stability and improved biology to improve the likelihood of a successful repair. This article discusses the indications, diagnosis, surgical techniques, and outcomes for RCR augmentation using an acellular dermal allograft, partially demineralized cancellous allograft, dermal xenograft, bone marrow aspirate concentrate, and platelet-rich plasma.

Efficacy of platelet-rich plasma and platelet-rich fibrin in arthroscopic rotator cuff repair: A systematic review and meta-analysis.

Basic scientific studies have demonstrated positive effects of platelet-rich therapies, such as platelet-rich plasma (PRP) and platelet-rich fibrin (PRF), on tendon repair. However, clinical evidence indicating improved prognosis is controversial. In this study, we aimed to determine whether augmentation of arthroscopic rotator cuff repair with PRP and PRF improves outcomes compared to arthroscopic repair alone. PubMed, Embase, and Cochrane library databases were comprehensively searched for randomized controlled trials (RCTs) published until June 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. No language restriction was applied. The primary outcomes were the rate of repeat tears after arthroscopic rotator cuff repair (retear rate) and clinical function scores (Constant-Murley Score, University of California, Los Angeles Score), and the extracted data were assessed for quality. Statistical analyses were performed using Review manager 5.3, and p < .05 was considered statistically significant. Ten RCTs with 628 patients were included. The results showed that augmenting surgery with PRP reduces retear rates compared to surgery alone (risk ratio [RR] = 0.40, 95% confidence interval [CI] 0.23-0.69, p = .001), whereas PRF has no effect on retear rates (p = .92). Regarding clinical function, PRP improves Constant-Murley scores (mean difference [MD] = 2.03, 95% CI 0.13-3.93, p = .04) and University of California, Los Angeles scores (MD = 1.30, 95% CI 0.36-2.24, p = .007), whereas PRF improves only Constant-Murley scores (MD = 3.93, 95% CI 1.50-6.36, p = .002). However, these differences were small and below the minimum clinically important difference threshold. This study showed that compared to arthroscopic rotator cuff repair alone, the application of PRP in arthroscopic rotator cuff repair reduces retear rate and improves clinical function scores, whereas the application of PRF has no clinically meaningful benefit. The small number and heterogeneity of studies as well as methodological limitations and risk of bias limit confidence in the true effect.

Rotator Cuff Repair with Knotless All-Suture Medial Row Anchors and Biceps Autograft Augmentation

Incomplete healing and/or functional failure following rotator cuff tear repair remains a challenging problem for both patients and surgeons. Augmentation strategies are growing to increase healing through biologic and mechanical mechanisms to improve functional results after arthroscopic rotator cuff repair. The majority of currently described augmentation techniques use allograft tissue. An alternative, low-cost, autograft option for augmentation is the use of the long head of biceps tendon autograft as a free functional graft. Here, we describe the use of autograft biceps tendon as a viable option for augmentation of double-row rotator cuff repair with knotless all-suture suture anchors.

Paper 50: Biceps Autograft Patch Augmentation for Rotator Cuff Repair: The Effect of Point of Care Compression on Tenocyte Viability.

Objectives: Augmentation of rotator cuff repair in patients at risk for retear has gained popularity. These techniques have generally consisted of allograft and xenograft patches. Recently, use of an autograft biceps from the normally discarded portion after biceps tenodesis was described as a potential patch for rotator cuff repair augmentation. As an autograft, it is free and readily available. The original description prepared the patch by placing it through a commercial skin graft preparation station. This technique results in a significant decrease in tenocyte viability, however, and results in a patch that is difficult to work with. Recently, an autograft compression plate has been employed to use as a point of care processor for adapting the discarded long head of the biceps after tenodesis into an autograft patch. The purpose of this study was to evaluate the feasibility of this point of care graft preparation method, and to specifically evaluate its effect on tenocyte viability in patients undergoing patch augmentation for rotator cuff repair. Methods: We reviewed the medical records of consecutive patients who underwent biceps tenodesis for either rotator cuff repair or anatomic shoulder arthroplasty. After tenodesis, and after 27 mm of the long head of the biceps was secured for compression into the patch, the remaining length of normally discarded tendon was longitudinally split, resulting in 2 equal lengths of remnant tendon from the same zone of the tendon. One sample was sent to pathology with no preparation, and the other was prepared as a biceps autograft patch using the autograft compression plate according to the manufacturer’s recommendations. Once prepared, this second biceps sample was sent to pathology along with the first. The request was to evaluate for tenocyte viability. Pathologists were not told which sample was compressed. Records were reviewed to determine if biceps tendon samples were viable at the time of harvest, and whether the compression process affected a change between the first and second specimen. Results: 20 consecutive patients were reviewed. All 20 biceps produced usable patches. The remnant biceps samples that were sent to pathology revealed the following: Sixteen of the 20 patients had biceps tenocyte viability that were read out as completely normal in both the compressed and non compressed samples. Of the 4 patients that did show some degree of tenocyte necrosis or death, 3 of the patients had identical findings between the compressed and non-compressed samples. Only 1/20 (5%) of the patients showed a difference between the compressed sample and the non-compressed sample, with the compressed sample demonstrating small areas of “patchy necrosis” while the non compressed sample showed normal tendon in that specimen. Conclusions: Compression of the long head of the biceps results in an autograft patch that is a promising option in rotator cuff augmentation. The method of compression plating to process the long head of the biceps remnant into an augmentation patch appears to have no significant effect on tenocyte viability, suggesting that the patch has live tenocytes at the time of point of care augmentation.

Poster 195: Retrospective Outcomes of Primary Rotator Cuff Repairs Involving Two or More Tendons

Poster 195: Retrospective Outcomes of Primary Rotator Cuff Repairs Involving Two or More Tendons

Clinical outcomes of rotator cuff repair with subacromial bursa reimplantation: a retrospective cohort study

The subacromial bursa has been found to be a rich, local, source of mesenchymal stem cells but is removed for visualization during rotator cuff repair. Reimplantation of this tissue may improve rotator cuff healing. The purpose of this study is to evaluate clinical outcomes of rotator cuff repair with and without subacromial bursa reimplantation. Patients aged 37-77 with a full-thickness or near full-thickness supraspinatus tears underwent arthroscopic transosseous-equivalent double row rotator cuff repair. In patients prior to July 2019, the subacromial bursa was resected for visualization, and discarded. In patients after July 2019, the subacromial bursa was collected using a filtration device connected to an arthroscopic shaver and reapplied to the bursal surface of the tendon at the completion of the rotator cuff repair. Rotator cuff integrity was evaluated via magnetic resonance imaging on bursa patients at 6 months postoperatively. Minimum 18-month clinical outcomes (Single Assessment Numeric Evaluation, American Shoulder and Elbow Surgeons, patient satisfaction) were compared between bursa and nonbursa cohorts. A total of 136 patients were included in the study (control n=110, bursa n=26). Preoperative demographics and tear characteristics were not different between groups. Average follow-up was significantly longer in the control group (control: 3.2±0.7 years; bursa: 1.8±0.3 years; P<.001). The control group showed a significantly higher Single Assessment Numeric Evaluation score (control: 87.9±15.8, bursa: 83.6±15.1, P=.037) that did not meet minimum clinically important difference. The American Shoulder and Elbow Surgeons and patient satisfaction scores were similar between the groups. Symptomatic retears were not significantly different between groups (control: 9.1%, bursa 7.7%, P=.86). Seven patients in the control group underwent reoperation (6.4%), compared to 0 patients in the bursa group (0%, P=.2). Six-month postoperative magnetic resonance images obtained on bursa patients demonstrated 85% rotator cuff continuity (n=17/20) as defined via Sugaya classification. Augmentation of rotator cuff repair with bursal tissue does not appear to have negative effects, and given the accessibility and ease of harvest of this tissue, further research should be performed to evaluate its potential for improved tendon healing or clinical outcomes.

Graft Augmentation of Rotator Cuff Repair Improves Load to Failure But Does Not Affect Stiffness or Gap Formation: A Meta-analysis of Biomechanical Studies

The purpose of this review was to examine the biomechanical properties of RCR-G with regard to ultimate load to failure, gap displacement, and stiffness. A systematic review was performed by searching PubMed, the Cochrane library, and Embase using PRISMA guidelines to identify studies that analyzed the biomechanical properties of RCR with graft augmentation. The search string implemented utilized the concepts "rotator cuff" and "graft," and "biomechanical" OR "cadaver." Meta-analysis was performed to provide a quantitative comparison of the two techniques. Primary outcome measures were ultimate load to failure (N), gap displacement (mm), and stiffness (N/mm). Initial search yielded 1,493 articles for review. Following screening for inclusion criteria, eight studies were included in the meta-analysis, including a total of 191 cadaveric specimens (106 RCR-G, 85 RCR). The pooled analysis from six studies reporting on ultimate load to failure revealed a statistically significant difference in favor of RCR-G compared to RCR (p < 0.001). Pooled analysis from six studies reporting on gap displacement failed to reveal a difference between RCR-G and RCR (p = 0.719). Pooled analysis from four studies reporting on stiffness failed to reveal a difference between RCR-G and RCR (p = 0.842). Graft augmentation of RCR in vitro resulted in significantly increased ultimate load to failure, with no influence on gap formation or stiffness. The biomechanical advantage of RCR with graft augmentation demonstrated via increased ultimate load to failure in cadaveric studies may provide an explanation for the decreased RCR retear rates and improved patient reported outcomes reported in the clinical literature regarding graft augmentation.

Rotator Cable Reconstruction: A Technique to Restore the Rotator Cable in the Setting of Large Cuff Tears

The rotator cable is an essential biomechanical structure in the shoulder that is commonly injured in the setting of large rotator cuff tears. Surgical techniques designed to reconstruct the cable have followed advancements in our understanding of the biomechanics and anatomic importance of this structure. Owing to its role in load sharing and stress shielding of the rotator cuff crescent, rotator cable reconstruction offers the potential to reduce retear rates and promote longevity of rotator cuff repairs. The purpose of this article is to describe a technique to augment rotator cuff repair with cable reconstruction.

Biphasic Interpositional Allograft for Rotator Cuff Repair Augmentation Is Safe in an Ovine Model

This study is a preclinical histological assessment of a biphasic acellular interpositional cancellous allograft in an ovine model of rotator cuff repair (RCR) designed to better understand its safety profile and effects on tendon healing after rotator cuff repair. Thirty skeletally mature sheep with clinically normal shoulders with an artificially created degenerative infraspinatus tendon (IST) tear were randomized to control and treatment groups. Animals were euthanized at 3-weeks, 6-weeks, and 12-weeks. After gross dissection, rotator cuff specimens were fixed with formalin and polymerized for sectioning and staining. Blinded histological scores evaluated inflammatory cell infiltrates, signs of degradation, particulate debris, collagen arrangement, neo-vascularization, and enthesis qualitative measures. There were no treatment specimens that exhibited histological signs of a significant infection, inflammatory infiltrate, or foreign body reaction such as granuloma or fibrous capsule formation. Histological scores in all categories were not significantly different at all time points, including the primary endpoint mean cumulative inflammatory score (control: 3.66 ± 1.21 versus treated: 4.33 ± 1.51, p = 0.42), when comparing the treatment and control RCR groups. In general, the degree of tendon healing and host tissue response was essentially equivalent between the two groups with observation of low overall levels of inflammation and progressive improvements in collagen organization, reduced tenocyte activity, and fibrocartilaginous enthesis reformation. This histological study demonstrated the use of a biphasic interpositional allograft for rotator cuff repair augmentation in an ovine model does not generate an inflammatory response or foreign body reaction. Use of the biphasic interpositional allograft resulted in a histological profile that was essentially equivalent to that of a standard RCR at 3-, 6-, and 12-week post-operative timepoints. These findings suggest that a biphasic interpositional allograft is safe for further clinical investigation in humans before broader clinical application. Patch augmentation of RCR is a popular technique that has shown clinical success in improving the likelihood of a successful repair in patients at elevated risk for retear. Newer augmentation technologies are being developed to address the biology at the interface between the bone and soft tissue where failure typically occurs.

Augmentation of Arthroscopic Rotator Cuff Repair With Cannulated Dermal Allograft Implant

Arthroscopic rotator cuff repair (RCR) is a popular treatment for rotator cuff tears. Retear after RCR remains a significant concern even with modern techniques. Augmentation of RCR has been described using multiple different grafts, one option including a cannulated dermal allograft implant (DePuy Mitek). The utilization of this implant avoids significantly increased surgical time, allows for augmentation at the weakest area of repair, and does not lead to any wasted allograft material.

Platelet lysate and tendon healing: comparative analysis of autologous frozen-thawed PRP and ketorolac tromethamine in the treatment of patients with rotator cuff tendinopathy

Platelet-rich blood derivatives are being nowadays increasingly used in the treatment of tendon-related pathologies as a rich source of growth factors. We sought to ascertain if local application of platelet lysate (PL) to augment rotator cuff repair ameliorates patient outcomes compared to ketorolac tromethamine treated group. A total of forty patients, with clinical diagnosis of Rotator Cuff Tendinopathy were randomized to receive sub acromial injections of PL every week for a total of 3 injections and two injection of ketorolac tromethamine once every two weeks. Subjective assessments included VAS, SPADI and shoulder range of motion were assessed at baseline and at 1 and 6 months after injection. Taking both control and PL groups, it was vividly seen that the outcomes were identical at the initial state, as well as the short-term one; whereas, when considering the 6-month period, there is a seemingly remarkable superiority in PL group in all parameters.

Arthroscopic Rotator Cuff Repair with a Fibrin Scaffold Containing Growth Factors and Autologous Progenitor Cells Derived From Humeral cBMA Improves Clinical Outcomes in High Risk Patients

PurposeTo report the clinical outcomes after biologically augmented rotator cuff repair (RCR) with a fibrin scaffold derived from autologous whole blood and supplemented with concentrated bone marrow aspirate (cBMA) harvested at the proximal humerus.MethodsPatients who underwent arthroscopic RCR with biologic augmentation using a fibrin clot scaffold (“Mega- Clot”) containing progenitor cells and growth factors from proximal humerus BMA and autologous whole blood between April 2015 and January 2018 were prospectively followed. Only high-risk patients in primary and revision cases that possessed relevant comorbidities or physically demanding occupation were included. Minimum follow-up for inclusion was 1 year. The visual analog score for pain (VAS), American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test (SST), Single Assessment Numerical Evaluation (SANE), and Constant-Murley scores were collected preoperatively and at final follow-up. In vitro analyses of the cBMA and fibrin clot using nucleated cell count, colony forming units, and live/dead assays were used to quantify the substrates.ResultsThirteen patients (56.9 ± 7.7 years) were included. The mean follow-up was 26.9 ± 17.7 months (n = 13). There were significant improvements in all outcome scores from the preoperative to the postoperative state: VAS (5.6 ± 2.5 to 3.1 ± 3.2; P < .001), ASES (42.0 ± 17.1 to 65.5 ± 30.6; P < .001), SST (3.2 ± 2.8 to 6.5 ± 4.7; P = .002), SANE (11.5 ± 15.6 to 50.3 ± 36.5; P < .001), and Constant-Murley (38.9 ± 17.5 to 58.1 ± 26.3; P < .001). Six patients (46%) had retears on postoperative MRI, despite all having improvements in pain and function except one. All failures were chronic rotator cuff tears, and all were revision cases except one (1.6 ± 0.5 previous RCRs). The representative sample of harvested cBMA showed an average of 28.5 ± 9.1 × 106 nucleated cells per mL.ConclusionsArthroscopic rotator cuff repairs that are biologically augmented with a fibrin scaffold containing growth factors and autologous progenitor cells derived from autologous whole blood and humeral cBMA can improve clinical outcomes in primary, as well as revision cases in high-risk patients. However, the incidence of retears remains a concern in this population, demanding further improvements in biologic augmentation.Level of EvidenceIV, therapeutic case series.