Rotator cuff disease ranks among the most prevalent of musculo-skeletal disorders. Previous studies in both cadavers and patient populations have found the prevalence of rotator cuff tears may exceed 50 percent in individuals older than age 65. Given that this age group is the fastest growing segment of the U.S. population, rotator cuff disease is poised to become an even more significant problem in the future.

Each year, approximately 200,000 Americans require shoulder surgery related to repair of the rotator cuff. An additional 400,000 Americans have surgery for related rotator cuff tendonitis or for partial tears. From a demographic standpoint, the treatment of the painful rotator cuff is an important musculoskeletal problem, which will only increase in importance as the population ages.

The large volume of clinical and research interest published in the orthopaedic literature in the last 10 years recognizes the relative importance of rotator cuff disease. These studies have attempted to address a multitude of important questions regarding rotator cuff treatment, including the following issues:

• The timing and role of non-surgical treatment such as steroid injections, physical therapy, or modalities
• The indications for chronic rotator cuff repair
• The surgical indications for acute traumatic tears
• The effect of multiple confounding factors such as age, diabetes, or smoking on surgical prognosis
• The most effective or appropriate surgical strategy, including débridement versus rotator cuff repair
• The most effective of the many available postoperative rehabilitation protocols

As with many orthopaedic problems, a multitude of different treatment options exist for the patient with a painful rotator cuff. Many of these treatment options have been controversial. Not surprisingly, available research finds little consensus among orthopaedic surgeons on rotator cuff treatment options. For example, 2005 study that examined the surgical indication patterns and the role of physical therapy in New York state found wide variations in surgeon preferences.

In this context, the AAOS assembled an evidence-based Clinical Practice Guideline (CPG) work group to identify the most important questions for treatment of the rotator cuff and the best evidence available to assist orthopaedic surgeons in determining the best standard of care.

Fourteen recommendations
The CPG work group formed for optimizing the management of rotator cuff problems identified 14 recommendations that address nonsurgical treatment, surgical indications, and postoperative treatment (Table 1). The work group considered the following issues:

1. Decision-making for asymptomatic patients with full thickness tears
2. Indications for nonsurgical treatment in patients with symptomatic tears
3. The relative role of physical therapy, steroid injections, anti-inflammatories, and other modalities for nonsurgical treatment
4. Indications for rotator cuff repair
5. The role of prognostic factors
6. The best practice, rehabilitation principles

Adjunct surgical issues—such as the use of bone tunnels or suture anchors and the addition of biologics to enhance healing—were also addressed.

Although the work group initially evaluated an extensive body of literature—more than 4,000 articles, they found very few that actually met the AAOS criteria for evidence. As a result, of the multiple recommendations in the guideline, none carry a “strong” grade.

Because the work group broke several of the recommendations into different parts, the final CPG has 31 total recommendations—4 classified with a moderate grade, 6 with a weak grade, and 19 as inconclusive. In addition, two recommendations carry a consensus of expert opinion, made in the absence of any reliable evidence and after considering the known harms and benefits associated with the treatment.

Unfortunately, the absence of evidence was the most important finding of this guideline process. It is certainly consistent with the multiple controversies surrounding rotator cuff disease as well as with the wide variations seen in treatment. A link to the summary of recommendations, the full guidelines, and supporting documents can be found on the AAOS Web site.

The work group strongly recommends that practitioners not rely solely on the summary, but that they also consult the full guideline and evidence report. Treatment decisions for an individual patient depend on that patient’s circumstances and mutual communication between the patient and the treating practitioner.

Need for future research
This evidence-based process underscores the strong need for quality evidence that orthopaedic surgeons can rely on in providing clinical care to patients with rotator cuff disease. Given the clinical importance of rotator cuff disease, the absence of good evidence represents a serious knowledge deficit.

The issue regarding evidence was not volume-related—it was related to quality problems. Although a number of research publications exist on the treatment of the rotator cuff, the overall quality of the studies was disappointing, given modern criteria for good evidence. The lack of previous, high-level research does not necessarily disprove previous findings or undermine current standard of care practices. It is entirely possible that higher level studies will simply confirm the use of popular treatment strategies such as steroid injections, tendon-to-bone repair of rotator cuffs, and physical therapy. Additionally, no high-level studies refuted current popular treatment practices; however, future high-level research will be important to improve confidence in specific treatment practices and to better standardize care.

The work group concluded that higher quality research that addresses the most important issues of rotator cuff treatment is needed. In particular, the following areas would benefit from high quality Level 1 or Level 2 studies:

1. Identifying risk factors for progression of rotator cuff disease. Some rotator cuff tears, both partial and full-thickness, will enlarge or degenerate with time. Because early treatment intervention in these cases may be important, identifying risk factors is an essential part of formulating treatment indications.
2. Determining the effectiveness of multiple, commonly employed nonsurgical treatment measures, such as the use of steroid injections or anti-inflamatory medications on the long-term prognosis of conservative management of rotator cuff tears.
3. Establishing whether and in whom rotator cuff healing is important. Rotator cuff repair and healing are generally the goals of surgical treatment; however, some patients have good results even though the tear does not heal. Identifying who requires healing and who does not will be important to determining what type of surgical treatment is necessary.
4. Determining the optimal rehabilitation protocol after rotator cuff repair. Issues such as when to start motion (early vs. delayed) and when to start resistive exercises are still controversial.
5. Determining the preferred surgical repair strategy. Multiple options, such as double row vs. single row repair, are still controversial. Evidence is needed to better standardize repair methods.
6. Increasing our understanding of the role of comorbidities—such as age, diabetes, or smoking history—on the prognosis after rotator cuff repair. These factors can affect surgical indications.
7. Determining the best surgical practice to treat the large, chronic tear that has a lower likelihood of healing after repair. These repairs may benefit only from débridement or, conversely, from larger reconstructions such as tendon transfers or the use of biologics.

How the guidelines came to be (PDF)

Disclosure information: Dr. Yamaguchi—Primary Investigator NIH-RO1 grant on the rotator cuff; royalties from Tornier (total elbow implant) and Zimmer (total shoulder implant). Ken Yamaguchi, MD, served as vice-chair of the work group.