Randomized controlled trials are difficult to conduct, explaining their paucity in the literature on the management of rotator cuff disease and the difficulty in establishing definitive guidelines for treatment.
This study by Moosmayer and colleagues represents one of the few randomized trials on patients with rotator cuff tears that compares surgical repair with nonoperative treatment. Although rotator cuff surgery is increasing in frequency, this study should be troubling to surgeons as the amount of improvement obtained with surgery is not great compared with a standard exercise program and, in fact, the gains in the Constant score are below the threshold for a clinically important difference.
It is also interesting to note that the failure of treatment for the two groups was similar. Of the fifty-one patients randomized to physiotherapy, nonoperative treatment was successful in 76% (thirty-nine patients) and unsuccessful in 24% (twelve patients) if failure is defined as crossing over to surgery. For sixty of the sixty-four patients treated with a rotator cuff repair, assessment of the integrity of the tendon was performed by sonography after five years, and postoperative imaging demonstrated complete healing in 75% (forty-five patients), with partial failure in 12% (seven patients) and complete failure in 13% (eight patients).
There were several limitations of this study. First, the authors report that, of the fifty-two cases in the primary tendon repair group, eighteen (35%) had a concomitant biceps tenodesis performed in addition to the rotator cuff repair. Unfortunately, this introduces considerable performance bias into the study. It is reasonable to expect that at least some of the improvement in outcomes in the primary tendon repair group may be related to the treatment of the biceps tendon and not to the rotator cuff repair.
Second, the authors did not distinguish outcomes for the three different types of rotator cuff tear mechanisms: acute tears, acute-on-chronic tears, and atraumatic rotator cuff tears in their populations of patients. Although the randomized design should stratify these patients into the surgical repair and nonoperative groups equally, when these patients are combined, we cannot know if surgery may produce better outcomes for one of the mechanisms that produced the rotator cuff tear. In fact, some lower-level evidence has suggested that rotator cuff repair produces better results than nonoperative treatment for acute tears with functional loss1. Interestingly, Kukkonen et al.2 conducted a randomized trial in patients with atraumatic rotator cuff tears for the use of home exercises; acromioplasty and home exercises; or rotator cuff repair, acromioplasty, and home exercises. Those authors failed to detect a difference in the Constant score at the one-year follow-up, suggesting that surgical repair may not be beneficial in the short term in patients with atraumatic rotator cuff tears.
In a similar vein, it would be helpful to know the patients’ primary concern driving them toward treatment. Is the patient having pain? Is the patient’s concern weakness or functional loss? The relationship between pain and rotator cuff integrity is not clear3-5. However, rotator cuff repairs that remain intact do have better strength5. The Constant score includes a measurement for strength, which represents 25% of the total score. It is interesting to note that the Constant score is no different for patients undergoing rotator cuff repair and patients treated nonoperatively at six months, but a difference does develop after that time favoring the rotator cuff repair group. It is conceivable that this difference is related to strength gains, suggesting that patients who present with weakness or functional loss may be better served with rotator cuff repair compared with patients who present with pain, who might be successfully managed nonoperatively.
It is unknown how patient expectations influenced the authors’ results. It has been demonstrated that patient expectations of treatment are strongly associated with the outcome of rotator cuff repair6 and the likelihood of successful nonoperative treatment of rotator cuff repairs7. As such, one could suspect that those patients who failed nonoperative treatment in this series had low expectations for the effectiveness of treatment compared with those who were treated successfully, and that feature is what drove the failure of nonoperative treatment.
Although the authors raise concern with progression of rotator cuff disease, which in their series did correlate with worse strength and Constant scores, their study was not designed to determine if surgery can influence the natural history of rotator cuff disease and can prevent progression.
In summary, this randomized trial is an important study in our quest to find the best treatment for patients with rotator cuff tears, yet clearly more work is needed to identify those patients who will do best with surgical repair and to determine if surgery can alter the natural history of rotator cuff tear progression in those patients susceptible to that concern.
1. Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63.
2. Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EKJ, Kauko T, Aärimaa V. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results. Bone Joint J. 2014 Jan;96-B(1):75-81.
3. The MOON Shoulder Group; Dunn WR, Kuhn JE, Sanders R, Baumgarten KM, Bishop JY, Brophy RH, Carey JL, Holloway GB, Jones GL, Ma CB, Marx RG, McCarty EC, Poddar SK, Smith MV, Spencer EE, Vidal AF, Wolf BR, Wright RW. Symptoms of pain do not correlate with rotator cuff tear severity: a cross sectional study of 393 patients with symptomatic atraumatic full thickness rotator cuff tears. J Bone Joint Surg Am. 2014 May 21;96(10):793-800.
4. Russell RD, Knight JR, Mulligan E, Khazzam MS. Structural integrity after rotator cuff repair does not correlate with patient function and pain: a meta-analysis. J Bone Joint Surg Am. 2014 Feb 19;96(4):265-71.
5. Slabaugh MA, Nho SJ, Grumet RC, Wilson JB, Seroyer ST, Frank RM, Romeo AA, Provencher MT, Verma NN. Does the literature confirm superior clinical results in radiographically healed rotator cuffs after rotator cuff repair? [Review]. Arthroscopy. 2010 Mar;26(3):393-403. Epub 2010 Jan 15.
6. Henn RF 3rd, Kang L, Tashjian RZ, Green A. Patients’ preoperative expectations predict the outcome of rotator cuff repair. J Bone Joint Surg Am. 2007 Sep;89(9):1913-9.
7. Dunn WR, Kuhn JE, Sanders R, Baumgarten KM, Bishop JY, Brophy RH, Carey JL, Holloway GB, Jones GL, Ma CB, Marx RG, McCarty EC, Poddar SK, Smith MV, Spencer EE, Vidal AF, Wolf BR, Wright RW. Defining indications for rotator cuff repair: predictors of failure of nonoperative treatment of chronic, symptomatic, full-thickness rotator cuff tears. J Shoulder Elbow Surg. 2013 Apr;22(4):e28.