Clinical Evidence for Suture Anchor Repair of Rotator Cuff Tears Does Add Up: Some Just Do Not Want to See It

Abstract

We read with great interest the Level V Evidence article by two of the great surgeons who advance shoulder arthroscopic surgery.1Burkhart S.S. Cole B.J. Bridging self-reinforcing double-row rotator cuff repair: We really are doing better.Arthroscopy. 2010; 26: 677-680Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar We pondered for many months whether to verbalize our thoughts. In the end, we have to confess: we are guilty. We did perform, to our knowledge, the first randomized controlled trial (RCT)2Franceschi F. Ruzzini L. Longo U.G. et al.Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: A randomized controlled trial.Am J Sports Med. 2007; 35: 1254-1260Crossref PubMed Scopus (338) Google Scholar comparing the clinical and imaging outcome after single- and double-row repair of large and massive rotator cuff tears. Given the time required to perform an RCT, it is not surprising that we used a “first-generation technique” described and used by at least one of them at the time when the trial was planned.3Lo I.K. Burkhart S.S. Double-row arthroscopic rotator cuff repair: Re-establishing the footprint of the rotator cuff.Arthroscopy. 2003; 19: 1035-1042Abstract Full Text Full Text PDF PubMed Scopus (268) Google ScholarIn our hands, single- and double-row techniques provide similar clinical outcomes. Double-row techniques do produce a mechanically superior construct in restoring the anatomic footprint of the rotator cuff, but these mechanical advantages do not translate into superior clinical performance.Our technical skills evolve, together with a better understanding of the biomechanics and biology of tendon-to-bone healing. Indeed, we ourselves understood this and have since described new techniques for double-row repair.4Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. The Roman bridge: A “double pulley–suture bridges” technique for rotator cuff repair.BMC Musculoskelet Disord. 2007; 8: 123Crossref PubMed Scopus (68) Google Scholar However, with the technique used at that time, and using the most sensitive way to assess integrity of the repair itself, magnetic resonance arthrography, we could not show superiority of the more technically complicated, more time-consuming, and more expensive construct. The fact that a preliminary power analysis had not been conducted may detract from the study design but not from the conclusions: these are based on sound clinical and statistical tests and were proven to be statistically and, in that context, clinically significant: single- and double-row repairs were clinically equivalent.2Franceschi F. Ruzzini L. Longo U.G. et al.Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: A randomized controlled trial.Am J Sports Med. 2007; 35: 1254-1260Crossref PubMed Scopus (338) Google Scholar In rotator cuff repair,4Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. The Roman bridge: A “double pulley–suture bridges” technique for rotator cuff repair.BMC Musculoskelet Disord. 2007; 8: 123Crossref PubMed Scopus (68) Google Scholar, 5Burks R. Study of rotator cuff repair techniques: We really are trying.Arthroscopy. 2010; 26: 1013-1020Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar, 6Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. Soft tissue tenodesis of the long head of the biceps tendon associated to the Roman Bridge repair.BMC Musculoskelet Disord. 2008; 9: 78Crossref PubMed Scopus (70) Google Scholar even restoration of integrity at imaging does not necessarily produce better clinical results. In this context, one should rely on the most sensitive imaging tests available: although in Europe ultrasonography is popular, to avoid possible criticisms of subjective interpretation from our North American colleagues, we undertook magnetic resonance arthrography.Everybody becomes very sanguine about their ideas, and it is difficult to maintain equipoise. This is the reason why, despite deep-seated convictions, one has to stand back and test hypotheses using Level I Evidence. It is difficult, time-consuming, and expensive, but it is what we have done and continue to do: a quick search on PubMed will bear witness to it. When we plan RCTs, we make sure that, to prevent the subtle differences in attitude engendered by stating “we wish to test whether procedure A produces better results than procedure B,” we test a null hypothesis of non-superiority of procedure A over procedure B.Like Dr. Burks, we do not have any hidden interests in trying to ascertain what is effective and cost-effective.7Longo U.G. Franceschi F. Spiezia F. Marinozzi A. Maffulli N. Denaro V. The low-profile Roman bridge technique for knotless double-row repair of the rotator cuff.Arch Orthop Trauma Surg. 2010 Nov 10; ([Epub ahead of print.])Google Scholar We invite researchers to stand back and adopt a healthy skepticism to advance our art and science of arthroscopy and, in general, orthopaedics and sports traumatology. By the way, there is no clinical evidence (and we mean Level I Evidence) that the more modern double-row techniques are clinically superior to the older ones, though mechanically they behave even better! We read with great interest the Level V Evidence article by two of the great surgeons who advance shoulder arthroscopic surgery.1Burkhart S.S. Cole B.J. Bridging self-reinforcing double-row rotator cuff repair: We really are doing better.Arthroscopy. 2010; 26: 677-680Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar We pondered for many months whether to verbalize our thoughts. In the end, we have to confess: we are guilty. We did perform, to our knowledge, the first randomized controlled trial (RCT)2Franceschi F. Ruzzini L. Longo U.G. et al.Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: A randomized controlled trial.Am J Sports Med. 2007; 35: 1254-1260Crossref PubMed Scopus (338) Google Scholar comparing the clinical and imaging outcome after single- and double-row repair of large and massive rotator cuff tears. Given the time required to perform an RCT, it is not surprising that we used a “first-generation technique” described and used by at least one of them at the time when the trial was planned.3Lo I.K. Burkhart S.S. Double-row arthroscopic rotator cuff repair: Re-establishing the footprint of the rotator cuff.Arthroscopy. 2003; 19: 1035-1042Abstract Full Text Full Text PDF PubMed Scopus (268) Google Scholar In our hands, single- and double-row techniques provide similar clinical outcomes. Double-row techniques do produce a mechanically superior construct in restoring the anatomic footprint of the rotator cuff, but these mechanical advantages do not translate into superior clinical performance. Our technical skills evolve, together with a better understanding of the biomechanics and biology of tendon-to-bone healing. Indeed, we ourselves understood this and have since described new techniques for double-row repair.4Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. The Roman bridge: A “double pulley–suture bridges” technique for rotator cuff repair.BMC Musculoskelet Disord. 2007; 8: 123Crossref PubMed Scopus (68) Google Scholar However, with the technique used at that time, and using the most sensitive way to assess integrity of the repair itself, magnetic resonance arthrography, we could not show superiority of the more technically complicated, more time-consuming, and more expensive construct. The fact that a preliminary power analysis had not been conducted may detract from the study design but not from the conclusions: these are based on sound clinical and statistical tests and were proven to be statistically and, in that context, clinically significant: single- and double-row repairs were clinically equivalent.2Franceschi F. Ruzzini L. Longo U.G. et al.Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: A randomized controlled trial.Am J Sports Med. 2007; 35: 1254-1260Crossref PubMed Scopus (338) Google Scholar In rotator cuff repair,4Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. The Roman bridge: A “double pulley–suture bridges” technique for rotator cuff repair.BMC Musculoskelet Disord. 2007; 8: 123Crossref PubMed Scopus (68) Google Scholar, 5Burks R. Study of rotator cuff repair techniques: We really are trying.Arthroscopy. 2010; 26: 1013-1020Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar, 6Franceschi F. Longo U.G. Ruzzini L. Rizzello G. Maffulli N. Denaro V. Soft tissue tenodesis of the long head of the biceps tendon associated to the Roman Bridge repair.BMC Musculoskelet Disord. 2008; 9: 78Crossref PubMed Scopus (70) Google Scholar even restoration of integrity at imaging does not necessarily produce better clinical results. In this context, one should rely on the most sensitive imaging tests available: although in Europe ultrasonography is popular, to avoid possible criticisms of subjective interpretation from our North American colleagues, we undertook magnetic resonance arthrography. Everybody becomes very sanguine about their ideas, and it is difficult to maintain equipoise. This is the reason why, despite deep-seated convictions, one has to stand back and test hypotheses using Level I Evidence. It is difficult, time-consuming, and expensive, but it is what we have done and continue to do: a quick search on PubMed will bear witness to it. When we plan RCTs, we make sure that, to prevent the subtle differences in attitude engendered by stating “we wish to test whether procedure A produces better results than procedure B,” we test a null hypothesis of non-superiority of procedure A over procedure B. Like Dr. Burks, we do not have any hidden interests in trying to ascertain what is effective and cost-effective.7Longo U.G. Franceschi F. Spiezia F. Marinozzi A. Maffulli N. Denaro V. The low-profile Roman bridge technique for knotless double-row repair of the rotator cuff.Arch Orthop Trauma Surg. 2010 Nov 10; ([Epub ahead of print.])Google Scholar We invite researchers to stand back and adopt a healthy skepticism to advance our art and science of arthroscopy and, in general, orthopaedics and sports traumatology. By the way, there is no clinical evidence (and we mean Level I Evidence) that the more modern double-row techniques are clinically superior to the older ones, though mechanically they behave even better! Bridging Self-Reinforcing Double-Row Rotator Cuff Repair: We Really Are Doing BetterArthroscopyVol. 26Issue 5PreviewSingle-row versus double-row repair of rotator cuff tears is currently a controversial topic. In this Level V article, we articulate why we believe that second-generation double-row repair techniques, which use bridging sutures to link the 2 rows of suture anchors together in a self-reinforcing manner, are producing superior clinical and biomechanical results. Full-Text PDF Author's ReplyArthroscopyVol. 26Issue 12PreviewWe would like to thank Dr. Maffulli and his colleagues for their thoughtful comments in response to our article, “Bridging Self-Reinforcing Double-Row Rotator Cuff Repair: We Really Are Doing Better.”1 For starters, touché! We love the title because it is just what the doctor ordered to fuel and continue this important dialogue. We concur: Maffulli et al. were the first to perform a randomized controlled trial examining the issue of whether clinical outcomes differ between single- and double-row techniques. Full-Text PDF