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Editorial Commentary: New Kid on the Block: Rotator Cuff Patch Augmentation Requires Rigorous Scrutiny
Editorial Commentary: New Kid on the Block: Rotator Cuff Patch Augmentation Requires Rigorous Scrutiny Jae Chul Yoo, M.D., Editorial Board
Abstract: There is still plenty of room for improvement in surgical rotator cuff repair healing as well as in nonsurgical cases. Adding an implant or patch to improve results has been a subject of much discussion for a couple of decades. The main problem has been that the surgical procedures are so difficult, with added time and its effect, and therefore are controversial. Many surgeons are reluctant to go the surgical route. As we have advanced technically, we are at a turning point, with newer implants that can be easily augmented. Therefore, recently many surgeons have been using implants, and preliminary reports seem promising. New implants must withstand vigorous challenges, and future extensive and long-term studies can enable improved implants using human tissue.
See related article on page 2262
T
he report published in this issue, “Patient-Reported Outcomes Following Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears” by McIntyre, Bishai, Brown, Bushnell, and Trenhaile,1 describes a multicenter study with a relatively large number (173 patients) of rotator cuff tears and repairs augmented with biologic bovine-derived collagen scaffold. Partial tears were not repaired but just augmented; fullthickness tears were repaired at the surgeon’s discretion and then augmented with the implant. The results show that both partial- and full-thickness tears demonstrated safety and efficacy at 1-year follow-up. Patient-reported outcomes showed that visual analog scale pain scores and American Shoulder and Elbow Surgeons scores met or exceeded the minimum clinically important difference by 70% to 80% of cases. The strengths of this study are that it is multicenter, with a relatively good design, and the early patientreported outcomes are good and look at very interesting parameters. In addition, patient-driven outcome is a very reliable and good method to evaluate patients, especially when it is performed by the same examiner.
The author reports no conflicts of interest in the authorship and publication of this article. Full ICMJE author disclosure forms are available for this article online, as supplementary material. Ó 2019 Published by Elsevier on behalf of the Arthroscopy Association of North America 0749-8063/19478/$36.00 https://doi.org/10.1016/j.arthro.2019.05.001
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However, in this study, parameters such as the time of sling application and return to work, driving, and sports seem to be vaguely applied, given that patient choice or surgeon choice is not made clear. Patient-driven postoperative rehabilitation seems to vary among the 15 surgeons in the study. Thus, in my opinion, all the data referring to faster recovery, shorter sling time, early return to work, and so on do not seem to be accurate measurements. Furthermore, there is no report on an improved healing rate in full-thickness tears after repair. It would be good to see better tendon quality after augmentation and a lower retear rate compared with nonaugmentation. In this field, there is much need for improvement. We need comparisons between those who did and did not have augmentation to see real differences. We need controls and comparisons, and these studies must include large samples. There have been patch augment studies, but they did not get much attention because they involved a more difficult surgery with much added time, especially in the arthroscopic environment.2-4 The difference in outcome was not much or only slightly better, but with the added surgical time (30 to 60 minutes), the technique was not generally accepted. However, this new augment implant, which is easy for the average arthroscopic surgeon to insert and implant with minimum added time, is popular. I think it will be a hot topic for quite a while. It is also very expensive, which makes it necessary to consider company-driven factors.
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 35, No 8 (August), 2019: pp 2272-2273
2273
EDITORIAL COMMENTARY
Nonetheless, if it really helps, then we should augment all tears and repairs with minimum added surgical time. One of the critical drawbacks is that this is a companyfunded study. There need to be studies that are not company driven and that look at this augment critically. There are limited reports on this new patch. There have been many reports on bovine scaffold augmentation or human dermal allograft, and many of them have shown better results. But the surgeons who have used it previously have all realized that it is a much more difficult surgery in the arthroscopic setting,2-4 so it was not widely accepted. However, this new implant will be easy to implement even arthroscopically, so I believe it will be the “new kid on the block.” Hopefully it will not only be new but useful. Another study looked at a different bovine product and showed similar results.5 Perhaps the product reported in that study was the basis for the product reported in the McIntyre et al. study. For both partial- and full-thickness tears, because of the ease of application of the implant, I would like to apply the implant in all cases if possible and see whether it really changes the patient outcomes, especially early outcomes, and maybe even compare it prospectively or retrospectively. It needs worldwide support to be accepted. In addition, improved implants, such as human-derived products and even custommade individually collected samples processed from our own tissue, could be generated in the laboratory as
a scaffold and reapplied (like platelet-rich plasma). This would be an even greater improvement. First, a Level III retrospective comparative study should be undertaken in several single-center or multicenter trials. After that, although it is very difficult to do a Level I randomized controlled trial, we might be able to do one in a multicenter study. I also think a postoperative magnetic resonance imaging study is needed in the near future to back up the healing rate: Is it better or the same?
References 1. McIntyre L, Bishai SK, Brown PB, Bushnell BD, Trenhaile SW. Patient-reported outcomes following use of a bioabsorbable collagen implant to treat partial and fullthickness rotator cuff tears. Arthroscopy 2019;35:2262-2271. 2. Barber FA, Burns JP, Deutsch A, Labbé MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy 2012;28:8-15. 3. Petri M, Warth RJ, Horan MP, Greenspoon JA, Millett PJ. Outcomes after open revision repair of massive rotator cuff tears with biologic patch augmentation. Arthroscopy 2016;32:1752-1760. 4. Murthi AM, Lankachandra M. Technologies to augment rotator cuff repair. Orthop Clin North Am 2019;50:103-108. 5. Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: A prospective multicenter study. J Shoulder Elbow Surg 2018;27: 242-251.
Abstract: There is still plenty of room for improvement in surgical rotator cuff repair healing as well as in nonsurgical cases. Adding an implant or patch to improve results has been a subject of much discussion for a couple of decades. The main problem has been that the surgical procedures are so difficult, with added time and its effect, and therefore are controversial. Many surgeons are reluctant to go the surgical route. As we have advanced technically, we are at a turning point, with newer implants that can be easily augmented. Therefore, recently many surgeons have been using implants, and preliminary reports seem promising. New implants must withstand vigorous challenges, and future extensive and long-term studies can enable improved implants using human tissue.
See related article on page 2262
T
he report published in this issue, “Patient-Reported Outcomes Following Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears” by McIntyre, Bishai, Brown, Bushnell, and Trenhaile,1 describes a multicenter study with a relatively large number (173 patients) of rotator cuff tears and repairs augmented with biologic bovine-derived collagen scaffold. Partial tears were not repaired but just augmented; fullthickness tears were repaired at the surgeon’s discretion and then augmented with the implant. The results show that both partial- and full-thickness tears demonstrated safety and efficacy at 1-year follow-up. Patient-reported outcomes showed that visual analog scale pain scores and American Shoulder and Elbow Surgeons scores met or exceeded the minimum clinically important difference by 70% to 80% of cases. The strengths of this study are that it is multicenter, with a relatively good design, and the early patientreported outcomes are good and look at very interesting parameters. In addition, patient-driven outcome is a very reliable and good method to evaluate patients, especially when it is performed by the same examiner.
The author reports no conflicts of interest in the authorship and publication of this article. Full ICMJE author disclosure forms are available for this article online, as supplementary material. Ó 2019 Published by Elsevier on behalf of the Arthroscopy Association of North America 0749-8063/19478/$36.00 https://doi.org/10.1016/j.arthro.2019.05.001
2272
However, in this study, parameters such as the time of sling application and return to work, driving, and sports seem to be vaguely applied, given that patient choice or surgeon choice is not made clear. Patient-driven postoperative rehabilitation seems to vary among the 15 surgeons in the study. Thus, in my opinion, all the data referring to faster recovery, shorter sling time, early return to work, and so on do not seem to be accurate measurements. Furthermore, there is no report on an improved healing rate in full-thickness tears after repair. It would be good to see better tendon quality after augmentation and a lower retear rate compared with nonaugmentation. In this field, there is much need for improvement. We need comparisons between those who did and did not have augmentation to see real differences. We need controls and comparisons, and these studies must include large samples. There have been patch augment studies, but they did not get much attention because they involved a more difficult surgery with much added time, especially in the arthroscopic environment.2-4 The difference in outcome was not much or only slightly better, but with the added surgical time (30 to 60 minutes), the technique was not generally accepted. However, this new augment implant, which is easy for the average arthroscopic surgeon to insert and implant with minimum added time, is popular. I think it will be a hot topic for quite a while. It is also very expensive, which makes it necessary to consider company-driven factors.
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 35, No 8 (August), 2019: pp 2272-2273
2273
EDITORIAL COMMENTARY
Nonetheless, if it really helps, then we should augment all tears and repairs with minimum added surgical time. One of the critical drawbacks is that this is a companyfunded study. There need to be studies that are not company driven and that look at this augment critically. There are limited reports on this new patch. There have been many reports on bovine scaffold augmentation or human dermal allograft, and many of them have shown better results. But the surgeons who have used it previously have all realized that it is a much more difficult surgery in the arthroscopic setting,2-4 so it was not widely accepted. However, this new implant will be easy to implement even arthroscopically, so I believe it will be the “new kid on the block.” Hopefully it will not only be new but useful. Another study looked at a different bovine product and showed similar results.5 Perhaps the product reported in that study was the basis for the product reported in the McIntyre et al. study. For both partial- and full-thickness tears, because of the ease of application of the implant, I would like to apply the implant in all cases if possible and see whether it really changes the patient outcomes, especially early outcomes, and maybe even compare it prospectively or retrospectively. It needs worldwide support to be accepted. In addition, improved implants, such as human-derived products and even custommade individually collected samples processed from our own tissue, could be generated in the laboratory as
a scaffold and reapplied (like platelet-rich plasma). This would be an even greater improvement. First, a Level III retrospective comparative study should be undertaken in several single-center or multicenter trials. After that, although it is very difficult to do a Level I randomized controlled trial, we might be able to do one in a multicenter study. I also think a postoperative magnetic resonance imaging study is needed in the near future to back up the healing rate: Is it better or the same?
References 1. McIntyre L, Bishai SK, Brown PB, Bushnell BD, Trenhaile SW. Patient-reported outcomes following use of a bioabsorbable collagen implant to treat partial and fullthickness rotator cuff tears. Arthroscopy 2019;35:2262-2271. 2. Barber FA, Burns JP, Deutsch A, Labbé MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy 2012;28:8-15. 3. Petri M, Warth RJ, Horan MP, Greenspoon JA, Millett PJ. Outcomes after open revision repair of massive rotator cuff tears with biologic patch augmentation. Arthroscopy 2016;32:1752-1760. 4. Murthi AM, Lankachandra M. Technologies to augment rotator cuff repair. Orthop Clin North Am 2019;50:103-108. 5. Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: A prospective multicenter study. J Shoulder Elbow Surg 2018;27: 242-251.