Outcomes Following Rotator Cuff Repair
Are We Doing Better?
Introduction
Assessing Outcomes Following Rotator Cuff Repair Surgery
Patient-Reported Outcome Measures
General Health Outcome Measures
General Shoulder Outcome Measures
Rotator Cuff–Specific Outcome Measures
Shoulder Activity Measure
Assessing Structural Integrity
Other Outcome Measures
Results of Rotator Cuff Repair
Open Rotator Cuff Repair
Miniopen Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
Double- versus Single-Row Repairs
Healed Versus Nonhealed Rotator Cuff Repairs
Outcomes Following Rotator Cuff Repair: Are We Doing Better?
Chapter 32
Brian R. Wolf, and Kyle R. Duchman
Ever since the first description over 200 years ago, rotator cuff tears have fascinated orthopedic surgeons. As surgeons moved away from simply identifying rotator cuff tears, focus moved toward treatment of these often debilitating injuries. The first English-language description of an open rotator cuff repair technique, now over 100 years ago, has been followed by a rapid evolution of changing management strategies, operative techniques, and postoperative protocols. The development of diagnostic imaging modalities, including arthrography and magnetic resonance imaging (MRI), has helped fuel this rapid evolution, as have advances in shoulder arthroscopy, which was first described nearly 85 years ago. These developments led to debates about the optimal treatment of rotator cuff tears, which initially compared open and arthroscopically driven miniopen repair techniques and eventually all-arthroscopic repair techniques. With continued technologic advances, debates have moved toward comparison of specific suture repair techniques, including single- and double-row techniques, with the most recent studies investigating the role of biologic agents or augmentations in rotator cuff repair.
Today, it is estimated that over 250,000 rotator cuff repairs are performed annually in the United States, with a dramatic increase in the number of rotator cuff repair procedures over the last decade. Similarly, the number of peer-reviewed publications on the rotator cuff has increased, with a nearly exponential increase in publications over the last 30 years, with rotator cuff–specific publications dominating recent clinical shoulder literature. Although the volume and breadth of literature are impressive, at times it seems as though more questions are raised than answers provided. This, at least in part, may be attributable to the difficulty in defining a successful rotator cuff repair. Defining success is complicated by the fact that there is great inconsistency throughout the literature when reporting surgical indications, particularly important given the high number of asymptomatic rotator cuff tears, and outcomes. Multiple outcomes are available for assessment of the shoulder. This includes patient-reported outcome measures as well as various imaging parameters to assess repair integrity. However, there has been a lack of consistency for assessment of strength and function. Although quality of life may improve after rotator cuff repair, other parameters, including maintenance of the structural integrity of the rotator cuff repair following surgery, have yielded less satisfying results. Despite the high volume of procedures and publications, evaluating the success of rotator cuff repair is hindered by inconsistent reporting of important variables throughout the literature. Although these shortcomings have been acknowledged and suggestions made to improve reporting, questions undoubtedly remain. This chapter evaluates the current best evidence available to better answer the question at the crux of rotator cuff repair surgery: Are we doing better?
Rotator cuff repair outcomes are typically reported using patient-reported outcome measures in combination with the structural integrity of the repair typically reported using MRI, sonography, or computed tomographic (CT) arthrography. With respect to patient-reported outcome measures, it has been suggested that validated measures, including a general health outcome measure, a general shoulder outcome measure, a rotator cuff–specific outcome measure, and an activity measure, be used to perform the highest level of assessment. The relatively recent addition of an activity measure is particularly useful because limiting upper-extremity activity may artificially increase patient-reported outcome measures that place less emphasis on function but are of historical relevance. The following will provide a brief overview of the most frequently used validated patient-reported outcome measures applicable to rotator cuff repair in order to better understand the results of rotator cuff repair surgery. Additionally, we discuss the role of advanced imaging in assessing the structural integrity of the rotator cuff following repair and the influence structural integrity may have on outcomes.
General health outcome measures allow comparison of patients with various conditions across medical specialties and within a variety of populations. These measures are important to rotator cuff repair outcomes because they allow comparison with other conditions. The Medical Outcomes Study 36-Item Short Form Healthy Survey (SF-36) and abbreviated Medical Outcomes Study 12-Item Short Form Healthy Survey (SF-12) are the most frequently used general health outcome measures in the orthopedic and general health literature and have been validated in a variety of languages and formats. The components of the SF-36 and SF-12 allow for calculation of a physical and mental component score, allowing comparison of health-related quality of life between a variety of disciplines and disease processes.
General shoulder outcome measures assess the role the shoulder specifically has on quality of life. Limiting evaluation to the anatomic region of interest eliminates other variables, including concomitant disease processes in other organ systems, which may affect general health outcome measures. Historically, general shoulder outcome measures have a long track record with widespread use, allowing comparison of outcomes for patients with a variety of shoulder conditions. We have selected several of the most frequently cited and validated general shoulder outcome measures to expand on below.
The Constant score, or Constant-Murley score as frequently referenced, provided one of the first dedicated shoulder outcome measures. Although predated by the nonvalidated University of California Los Angeles shoulder score, the Constant score became the standard for future validations. The Constant score’s applicability to rotator cuff repair outcomes rests primarily on the range of motion and strength testing components, both of which are heavily weighted in calculation of the score. However, poor interrater reliability and inconsistencies in strength measurements have called into question the utility of the Constant score. Still, the widespread use of the score throughout the shoulder literature cannot be questioned.
The American Shoulder and Elbow Surgeons (ASES) score was created by the research committee of the ASES in order to standardize shoulder outcomes for the purpose of comparative and multiinstitutional research. It has been validated for evaluation of rotator cuff disease and has been shown to have excellent reliability. Unlike the Constant score, the ASES score lacks a physical exam component and places a heavy emphasis on pain in calculation of the composite score. Because of this, there is some concern that patients with high functional status where pain is not the primary concern, such as athletes, may not be distinguished.
The Simple Shoulder Test (SST) consists of 12 yes-or-no questions, all equally weighted, in order to provide a shoulder outcome measure with minimal patient time requirements. Despite the inherent simplicity of the test, the SST has been validated for patients with rotator cuff disease while serving to be less burdensome for patients than more robust general shoulder outcome measures that may require more time for data acquisition.
The Disabilities of the Arm, Shoulder and Hand (DASH) score was developed in an attempt to better assess upper extremity disability using a single questionnaire. Although the entire upper extremity as a whole is evaluated, the DASH has been validated for assessment of rotator cuff repair outcomes. Although the assumption that the DASH score is a generalized upper extremity outcome measure may limit its use within the shoulder literature, the correlation and subsequent validation of the DASH with a wide variety of shoulder pathologies should only further serve to strengthen its use in the shoulder literature.
There are two disease-specific outcome measures designed for rotator cuff pathology, including the Western Ontario Rotator Cuff (WORC) Index and the Rotator Cuff Quality of Life score. To date, the WORC Index has been used more extensively and has undergone more vigorous validation, with some suggesting that it is the most responsive to detecting changes in outcomes following rotator cuff repair surgery. Although disease-specific outcome measures are important tools, the more widespread use of general shoulder outcome measures that have been further validated to specifically assess rotator cuff disease, including the ASES, SST, and DASH, has limited the adoption of rotator cuff–specific outcome measures.
The shoulder activity level is a relatively new but important outcome measure developed to be used in addition to generalized health and shoulder outcome measures. The shoulder activity level takes into account patients who may decrease their activity due to their shoulder disease but still score highly on traditional tests focused on pain. Although not widely adopted yet, this validated outcome measure will become important in assessing patients with higher functional levels.
At the most basic level, the goal of rotator cuff repair is to restore the position and environment of the rotator cuff tendons to allow tendon-to-bone healing that ultimately withstands physiologic loads and allows improvement in pain and return of form and function. Although this is the goal, loss of structural integrity of the rotator cuff enthesis continues to occur at a relatively high rate and by most standards is considered a failure. However, the relationship between patient-reported outcomes, strength, and function in patients with and without failed rotator cuff repair has been studied extensively with inconsistent results. The differences most consistently demonstrated by these two populations are in strength and function. Because of this, assessment of the structural integrity of the rotator cuff repair remains an important element for rotator cuff repair research.
The two imaging modalities most commonly implemented to assess the structural integrity of the rotator cuff after repair are MRI and ultrasound. Although CT arthrography is still used, concerns with radiation exposure and the increased access to MRI have diminished the utility of CT arthrography. Both MRI and ultrasound have shown good sensitivity and specificity in detecting rotator cuff tears, with a notable learning curve when using ultrasound. Postoperative MRI and ultrasound after rotator cuff repair pose unique challenges with addition of artifact and alterations in bony anatomy; yet, both modalities have shown excellent reliability when it comes to assessing the structural integrity of the repaired rotator cuff. For research purposes, both methods have proven to be effective and safe for patients, but consistently reporting and classifying other factors that are important for outcomes following rotator cuff repair, including fatty infiltration and tear size, will be important in the future.
In addition to patient-reported outcome measures and postoperative imaging, other measures frequently reported in the literature include strength, range of motion, and return to work, sport, or previous level of activity. Although these measures are certainly important, their use in the literature has been hindered by inconsistent definitions and classification systems, limiting comparisons between studies. For example, strength assessment even for a single test has been shown to be highly variable and is not an isolated component in the ASES or Constant scores. Range-of-motion assessment also varies substantially, ranging from goniometer-measured range of motion to assessment by simple hand positions. These shortcomings have limited the use of these measures as compared with the more objective patient-reported outcome measures and imaging results.
Since the first description of rotator cuff repair now over 100 years ago, many conceptual and technical modifications have been made to improve outcomes for patients undergoing rotator cuff repair surgery. Despite the increased volume of literature and assumed technical improvements, there remains relatively little high-quality evidence-based literature to guide practice and monitor changes in outcomes over this time period. Furthermore, the wide variety of rotator cuff pathology combined with patient demographic factors that have been shown to influence outcomes can make interpreting the literature an almost daunting task. The subsections below chronologically evaluate outcomes for rotator cuff repair from open to all-arthroscopic techniques while also addressing treatment controversies that have been raised and debated over time in order to better understand how outcomes today compare with those over the century-long history of rotator cuff repair.
The first rotator cuff repair was an open repair described by Codman in 1911. The original technique was revolutionized by Neer, whose principles for rotator cuff repair still largely stand today. The results of open rotator cuff repair were an improvement from the reports on rotator cuff debridement and subacromial decompression performed previously, with significant improvements in pain and function noted at long-term follow-up, whereas results with respect to the structural integrity of repairs in patients with massive rotator cuff tears deteriorated with time, with a notable decline in clinical outcomes in those patients with failed repairs. The concern with taking down the deltoid origin and subsequent deltoid atrophy combined with the emergence of arthroscopy as a reliable diagnostic tool in the shoulder paved the way for better visualization and smaller incisions for treatment of rotator cuff tears.
Advances in shoulder arthroscopy from the original cadaveric study by Burman in 1931 allowed for development of the miniopen repair technique, at times referred to as the arthroscopically assisted repair technique, which was popularized by Levy and colleagues. Using this technique, arthroscopy served primarily as a diagnostic tool, identifying and localizing the rotator cuff tear to allow smaller incisions and preserve the deltoid origin during the miniopen repair. Importantly, the use of arthroscopy in combination with miniopen repair techniques also identified concomitant shoulder pathology that could be addressed at the time of surgery. Levy’s early results were promising and supported by subsequent studies that noted significant improvements in pain and function, even in the overhead athlete where return to sport was achieved more frequently than in those treated with open repair techniques. Despite the technical advances, it was also during this time period that the literature consistently pointed out inferior outcomes following repair of large tears with both open and miniopen techniques.
Compared with open rotator cuff repair, miniopen rotator cuff repair provided several advantages, including the aforementioned ability to assess the entire glenohumeral joint and associated structures through a less invasive approach. In addition, maintenance of the “deltoid sleeve,” as coined by Warner, and limited dissection resulted in improved early pain control while decreasing length of stay. Baker and Liu conducted one of the first studies to compare open with miniopen rotator cuff repair and found that miniopen repair resulted in significantly greater shoulder abduction strength, decreased hospital length of stay, and earlier return to full activity for moderately sized tears than open repairs, while noting no difference in repair integrity. In one of the few randomized clinical trials comparing open with miniopen rotator cuff repairs, Mohtadi and colleagues found that miniopen repair resulted in superior general health and general shoulder outcome measures at 3 months, although the results for the two groups were equivalent at 1 and 2 years postoperatively. On the basis of these studies, the ability to inspect the glenohumeral joint with concomitant treatment of identified pathology, preservation of the deltoid origin, shorter hospital length of stay, early return to work, and improved early clinical outcomes for small- and medium-sized tears were significant improvements compared with open rotator cuff repair, whereas results for treatment of large tears continued to be less than satisfying when addressed by either open or miniopen techniques.
As arthroscopic technology continued to advance, surgeons familiar with the technique began to experiment further with techniques that would limit dissection and exposure during rotator cuff repair while still providing the same diagnostic advantages of the miniopen repair technique. However, repairing rotator cuff tears using suture-based techniques through small portal incisions presented several new challenges. The first published description of an all-arthroscopic knot was published by Thal in 1993. This technical pearl was followed by further advances, including improvements in anchor fixation, evolution of knot-tying techniques, techniques for arthroscopic margin convergence and interval slides, and eventually Lo and Burkhart’s original double-row repair technique description. Today, arthroscopic rotator cuff repair is the preferred technique by over 70% of practicing shoulder surgeons across the United States, with successful mid- and long-term clinical results reported. Additionally, several authors have reported more optimistic results for large or massive rotator cuff tears repaired using arthroscopic techniques, potentially due to the improved ability to visualize and mobilize the rotator cuff from multiple angles using arthroscopic techniques as compared with the concerns with large or massive tears reported during open rotator cuff repair.
A number of studies have compared the outcomes of open or miniopen rotator cuff repair with arthroscopic repair. Despite the large volume of literature, there remain relatively few high-quality comparative studies to provide answers. Open and miniopen approaches provide the theoretical advantage of transosseous fixation of the rotator cuff as compared with suture anchor fixation, although there is no in vivo comparative study to validate this concern. Additionally, improvements in suture anchor constructs and the development of suture bridge and transosseous equivalent constructs, as well as development of arthroscopic transosseous techniques, have quieted this debate. Arthroscopic repair provides the advantage of limited exposure and soft-tissue dissection while allowing visualization of the entire rotator cuff as compared with open and miniopen techniques, with few studies noting less stiffness and early postoperative pain with use of arthroscopic techniques. Despite these proposed advantages and disadvantages, clinical outcomes for arthroscopic and miniopen rotator cuff repairs have been consistently equivalent when evaluated in several systematic reviews and metaanalyses. A single study evaluated only the structural integrity or repair failure of all three repair techniques using ultrasound or MRI and found that surgical approach had no effect on the retear rate after repair. Currently, the literature does not support an advantage for one particular approach with respect to clinical outcomes and retear rates, although it should be noted that high-quality studies are lacking.
The first published description of the double-row suture anchor technique was provided by Lo and Burkhart in 2003. Since that time, the double- versus single-row debate has dominated the literature, with biomechanical studies, randomized controlled trials, and eventually systematic reviews and metaanalyses taking aim at the question. The description of the double-row technique in 2003 was prompted by improved knowledge of the rotator cuff footprint as well as concern with reported retear rates as high as 94% for massive tears treated with the single-row technique. Early biomechanical studies showed improved fixation strength, load to failure, and decreased gap formation with double-row repairs as compared with single-row repairs. Early clinical studies were promising, with retear rates less than 20% reported, but comparative studies often failed to note a difference in clinical outcomes, including retear rates, between single- and double-row repair.
With inconsistent results and a large volume of data available, the question became a target of several systematic reviews with incorporated metaanalysis. The systematic review by Saridakis and Jones concluded that structural healing was improved with double-row repair, although only four studies were included in this portion of the review and descriptions of structural healing or integrity varied between those studies. There were no differences in patient-reported outcome measures in the systematic review, although it was noted that general shoulder outcome scores were improved in patients with large to massive tears in the single study that stratified outcomes on the basis of tear size. More recently, Mascarenhas and colleagues performed a systematic review of overlapping levels I and II metaanalyses to further explore the single- versus double-row debate. This well-done study, which acknowledged the disparate conclusions provided in the literature, concluded that double-row repair resulted in higher structural healing rates while noting that the majority of included systematic reviews did not find a difference between patient-reported outcomes for single- versus double-row repair. However, it was again noted that superior patient-reported outcomes were seen with double-row repair in studies that stratified tears measuring greater than 3 cm. The systematic review by Duquin and colleagues evaluated retear rates between single- and double-row repairs using one of the largest aggregate samples to date in their metaanalysis. They found that retear rates were significantly lower for double-row repairs than for single-row repairs, concluding that double-row repairs should be considered for any tear measuring greater than 1 cm. Advocates of the double-row repair technique cite the superior biomechanical properties, restoration of the anatomic footprint, and higher clinical healing rates as distinct advantages of modern double-row repair techniques while noting that currently employed general shoulder outcome measures often fail to separate strength as a primary outcome and thus overlook the potential primary advantage of double-row repair. Critics believe that the increased operative time, technical demands, and costs, particularly in today’s healthcare arena, are not warranted with the current evidence. The answer to this widely debated question is only as satisfying as the literature provided, which currently suggests that double-row repairs display lower retear rates than single-row repairs, whereas clinical outcomes, using our current patient-reported methods, remain equivalent.
Despite the previously discussed advances in rotator cuff repair technique, healing of the rotator cuff after repair remains an issue. Nonhealed rotator cuff repairs are referred to as repair failures, structural failures, or tears with loss of structural integrity throughout the literature. Repair failures, as we refer to nonhealed rotator cuff repairs throughout this section, have been well documented, particularly for large or massive rotator cuff tears, where failure rates ranging from 41% to 69% are frequently cited, with a single study reporting a 94% failure rate. Although failure rates of large tears typically receive the most attention, even small tears demonstrate a consistent failure rate, which appears to plague both open and arthroscopic approaches. Although assessing the structural integrity of rotator cuff repairs, and thus determining repair failure, remains an important outcome measure, understanding the natural history of these so-called repair failures is important. Jost and colleagues presented the long-term outcomes of patients with repair failures with an average follow-up of 7.6 years. In their study, repair failures remained smaller than the original tears, were capable of spontaneous healing, and were generally well tolerated, without deterioration of clinical results compared with earlier postoperative time points. The authors described their findings in contrast to the outcomes of rotator cuff debridement, where deteriorating clinical outcomes are reported, and untreated tears, where propagation of tears and thus increase in tear size is common and spontaneous healing is not seen. However, the authors did caution that despite the consistent clinical results, some structural concerns, including superior migration of the humeral head and increased fatty degeneration, were seen at a higher rate than in individuals without repair failure. Although previous studies had recognized similar clinical outcomes for patients with intact repairs and those with repair failures, the long-term results reported by Jost et al. described a different natural history for these tears as compared with untreated tears while also leading some to question whether structural integrity of the repaired rotator cuff really mattered.