Author Reply to “Regarding ‘Clinical Outcomes of Arthroscopic Treatment of High‐Grade Partial Thickness Rotator Cuff Tears With Augmentation Using Bioinductive Collagen Implants Are Comparable With Tear Completion and Repair’”

We thank Gerhold et al. for their letter to editor1 regarding our study on the clinical outcomes of arthroscopic treatment of high-grade partial thickness rotator cuff tears (RCTs) with bioinductive collagen implants (BCI).2 BCI has emerged as an important technology to help address the persistent challenge of RCT healing.3 BCI has a direct cost which is currently greater than traditional implants. It should be noted that in our study, BCI alone was used, and hence, there were no anchor-related costs. This is in contrast to the highlighted McIntyre et al.4 and Rognoni et al.5 studies, both of which showed augmented repair with the cost of both BCI and anchors to be cost-effective in the treatment of full-thickness (FT)-RCTs. Although given the difference in tear characteristics, only cautious comparisons should be made. Regarding other direct costs, there was a significant time saving of 12 minutes with BCI repair (P = .001), which is known to be a significant driver of operating room costs in those undergoing cuff repair.6 Gerhold et al. highlight a benefit of BCI to be the potential for accelerated rehab. Bushnell et al.7 prescribed such a protocol (5-7 days of sling use) in their study comparing isolated BCI versus augmented takedown repair and reported significantly faster weening from the sling and superior functional outcomes after BCI at 2 and 6 weeks, with no difference at 1 year. Camacho Chacón et al.8 in their randomized controlled trial of BCI versus anchor repair for FT-RCTs prescribed a protocol of 14 days in a sling for both groups and showed significantly faster weening from the sling, earlier return to work, and fewer physiotherapy visits in the BCI group. Accelerated rehab after BCI was used in our study; however, due to the data collection intervals employed, we were unable to report similar post-operative outcomes, although the available literature does support an earlier return to function after BCI. The commenters highlight that no statistically significant differences were observed between BCI and anchor repair over the relatively short term follow-up of our study. This mirrors the majority of similar literature,7, 9, 10 with the exception of the aforementioned randomized controlled trial by Camacho Chacón et al.8 which reported significantly greater ASES and Constant scores after BCI at 6, 12, and 24 months and the randomized controlled trial by Ruiz Iban et al.9 which showed reduced retear rates, both of which looked at FT-RCTs. However, the findings of our comparative study add to the small but growing body of evidence that BCI results in good clinical outcomes over short term follow-up after PT-RCT and can be used in isolation without traditional repair.11 Of note, the concerning rate of stiffness previously reported after BCI for PT-RCTs was not observed.12 The randomized controlled trial by Ruiz Iban et al.9 did not show a statistical difference in mean ASES or Constant scores or in achievement of the minimum clinically important difference with BCI augmented repair. The BCI group had a significantly lower imaging confirmed retear rate (12.3% vs 35.1%, P = .004), with no difference in the revision repair rate (0% vs 3.2%, P = .492). They also showed patients without retear obtained significantly improved functional outcomes and minimum clinically important difference achievement. The aggregate analysis may not show an overall statistical difference, but at an individual-patient level, the prevention of tendon retears improves functional outcomes and may lead to cost-effectiveness in the long-term. Retears may not be as common after PT-RCTs such as in the population in our study, but it remains a substantial issue, particularly over long-term follow-up and a target to improve outcomes. The literature assessing the cost of RCT treatment shows inconclusive evidence for the cost-effectiveness: of supervised physical therapy over unsupervised,13-15 for arthroscopic repair over open16-18 and increased costs with the addition of regional anaesthesia.6 However, these interventions have clearly advanced the care of RCTs. Even the decision of when to operate on a RCT must be carefully examined and should always be patient specific.19-22 Surgeons have a duty to patients to operate in a fiscally responsible manner and to be cost conscious in a changing reimbursement environment.23, 24 However, this must not come at the expense of innovation or the pursuit of progress. While BCI results in excellent PT-RCT healing,3 and this study had important clinical findings,2 the authors’ agree that future cost-effectiveness studies on this topic will ultimately be required. As Gerhold et al. highlight, this should be based on a randomized trial with accelerated rehab. The analysis should include both early return to function and long-term follow-up (5 to ≥10 years) assessing functional outcomes, tendon retear, and reoperation data. The authors (C.S.K., O.A.) declare the following financial interests/personal relationships which may be considered as potential competing interests: C.S.K. reports a relationship with Acumed, LLC, that includes consultation or advisory fees; reports a relationship with Restore3d that includes consultation or advisory fees; reports a relationship with Smith & Nephew that includes consultation or advisory fees; reports a relationship with GE Healthcare that includes stock or stock options; reports a relationship with Johnson & Johnson that includes stock or stock options; reports a relationship with Merck that includes stock or stock options; and reports a relationship with Pfizer that includes stock or stock options. O.A. reports a relationship with Exactech, Inc., that includes consultation or advisory fees; reports a relationship with LIMA that includes consultation or advisory fees; reports a relationship with Smith & Nephew that includes consultation or advisory fees; reports a relationship with Responsive Arthroscopy that includes consultation or advisory fees; and reports a relationship with Suture Tech that includes stock or stock options. The other authors (T.R.D., E.T.H., S.G.L., D.V.B., M.M.C.) declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article.