Sunday, August 23, 2015

Rotator cuff tears involving two or more tendons - what to do about them?

Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes.

These authors review the management options for two tendon ("massive") rotator cuff tears. We've highlighted a few quotes from the article:

Repair fails in ~ 40% of the cases: "In an effort to identify factors associated with healing, Chung et al investigated 108 patients who underwent arthroscopic repair of massive cuff tears at a minimum of 1 year of follow-up. Anatomic failures occurred in 39.8% of patients. This is a comparable retear rate to that reported by Zumstein et al (57%), Miller et al (41%), Kim et al (42.4%), and Park et al (25%). "

The healing time for a repair is longer than what we have been led to believe"The optimal postoperative rehabilitation strategy to promote healing has yet to be determined. The ideal protocol protects the repair construct during the healing process while minimizing the risk of postoperative stiffness. A study conducted by Iannotti et al investigated the time to failure after rotator cuff repair of full-thickness tears ranging from 1 to 4 cm. The investigators found that the majority of retears occurred between 6 and 26 weeks postoperatively, suggesting that rehabilitation should focus on protecting the repair for a longer time."

In view of the above two observations, why not try non-operative management?: "A study conducted by Zingg et al evaluated the clinical and structural midterm outcomes in 19 patients with nonoperatively managed massive rotator cuff tears, defined as full-thickness complete tears of at least 2 tendons. After a mean follow-up duration of 48 months, the mean relative Constant score was 83%."

Comment: This article prompted us to resurface some of the content of three previous posts:

(1) Rotator cuff tear and rotator cuff wear.
 "The rotator cuff is the only tendon structure situated between two bones. Compressed between the acromion and the humerus by every motion of the shoulder, it succumbs to the ravages of attrition long before most other tendons. In youth, it is thick, strong, and elastic and can be disrupted only by great force; after middle age, it has worn thin and often becomes so weak and brittle that it ruptures with ease." McLaughlin 1962

Detachment of the rotator cuff tendons from the greater tuberosity is often described as a rotator cuff tear. The word 'tear' suggests an acute process, such as tear in otherwise great blue jeans that can be easily repaired.

On the other hand, most cuff defects arise in tendons of suboptimal quality without an acute traumatic episode and may be better referred to as cuff wear, similar to defects in worn jeans that defy repair.

We emphasize the distinction in an article on rotator cuff failure in the New England Journal as well as in the text, The Shoulder, where we quote McLauhglin's admonition regarding 'rotten cloth to sew' in an Instructional Course Lecture: "The wise surgeon, realizing that he may find little but rotten cloth to sew, will operate only by necessity and make a carefully guarded prognosis. [There was complete agreement of the Panel on this point.]" See his 1962 article.

(2) Some of our most distinguished colleagues set out to model the societal and economic value of rotator cuff repair.

As they point out rotator cuff tears are common in the United States, but the effect of cuff tears on earnings, missed workdays, and disability payments has not been well defined. As they point out in the introduction, long-term clinical studies of cost effectiveness 'do not exist'. This is a sad commentary on the state of clinical research in that hundreds of thousands of cuff repairs are performed each year, providing a huge opportunity for long term studies of the actual costs of cuff tears as well as the effectiveness of operative and non-operative management of different types of cuff tears in different types of patients using different techniques by different providers (see the 4Ps).

In the absence of real data, the authors' goal was to estimate the value of surgical treatment for full-thickness rotator cuff tears from a societal perspective using a Markov decision model of the lifetime direct and indirect costs (e.g. inability to work, lower wages, missed workdays, disability payments) associated with surgical and continued nonoperative treatment for symptomatic full-thickness rotator cuff tears. Patients with a symptomatic full-thickness rotator cuff tear 'underwent' either open or arthroscopic rotator cuff repair or continued to receive nonoperative treatment. After one year, all rotator cuff repairs resulted in either (1) healed rotator cuff repair (symptomatic and asymptomatic), (2) asymptomatic retear, (3) symptomatic retear, or (4) death; shoulders treated without surgery resulted in either (1) symptomatic tear, (2) asymptomatic tear, or (3) death.

The model indicated that surgical treatment results in an average improvement of 0.62 QALY. The model suggested that the age-weighted mean total societal savings from rotator cuff repair compared with nonoperative treatment was $13,771 over the lifetime of the patient. Savings ranged from + $77,662 for patients who are thirty to thirty-nine years old to - $11,997 for those who are seventy to seventy-nine years old.

The model concluded that "rotator cuff repair is cost-effective for all populations" and "The estimated lifetime societal savings of the approximately 250,000 rotator cuff repairs performed in the U.S. each year was $3.44 billion." This is a staggering figure.

Because actual data were not available for many of the key elements in the model, values were based on Level V assumptions. As the authors point out 'evidence to support some of the model assumptions is limited.'These assumptions had a strong influence on the results. Here are some considerations of the assumptions used:

(1) It was assumed that all symptomatic full-thickness rotator cuff tears assigned to the repair group were repairable, whereas this does not seem to be the common experience
(2) The model recognizes that healed repairs can be symptomatic or asymptomatic, but does not assume any disability if the healed repair is symptomatic, whereas we have all seen patients who are unable to return to work after a symptomatic "successful" cuff repair.
(3) The long term retear rate after cuff repair was assumed to be 2%, whereas a recent post found retear rates after one year approximating 10%.
(4) Patient outcomes for all repairs were assumed to be the same as those of seventy-three patients who underwent surgery at a large orthopaedic surgery group; presumably those cases represented careful selection of patients, of reparable cuff tears, and excellent surgical technique by a well trained shoulder surgeon, whereas many patients with cuff tears are not prime surgical candidates, have irreparable cuff tears and may be cared for by surgeons who are not specialized in shoulder (see the 4Ps: problem, patient, procedure, physician).
(5) It was assumed that workers lost an average of twenty-eight additional days as a result of rotator cuff repair compared with those undergoing non-operative treatments, whereas recent data suggests that repairs should be protected from loading for up to six months after surgery. In that many cuff tears occur in those with physical laboring jobs, the 28 days seems like a short interval for return to work. Furthermore, it is not clear that cuff tears treated with non-operative management need to miss work at all.
(6) The model assumed complication rates of stiffness (2.5%) and of infection (0.1%) following rotator cuff repair, whereas some studies have reported a complication rate of 10.6% of which the most common was persistent stiffness.
(7) The model used an expensive approach to non-operative management costing $1802, whereas there is substantial evidence that an inexpensive home program provides an effective method for non-operative management.
(8) The model assumes that only 5% of asymptomatic retears following repair become symptomatic annually, whereas it assumes that 8.8% of asymptomatic tears managed non-operatively become symptomatic per year.

These and other assumptions led the model to conclude that "rotator cuff repair produces societal cost savings for patients under the age of sixty-one years and is cost-effective for all patients". However, it is easy to see that different assumptions might have led to a different answer. 

It may be worthwhile to reflect on whether this model addresses the right question. No one would doubt that a successful rotator cuff repair that returns a worker to work is a good thing for that person and for society. On the other hand non-operative management can be of value to many patients. The real question is 'how do we decide which rotator cuff tears in which patients will benefit from rotator cuff repair and the critical post-operative rehabilitation period that must follow?'. The model's conclusion that 'rotator cuff repair is cost-saving across all patients' does not change the fact that many cuff tears are not reparable and that many patients with cuff tears are not good candidates for cuff repair. 

In terms of guidance, the model leaves us with the quizzical statement "Although rotator cuff repair is cost-saving across all patients, nonoperative treatment is the preferred strategy for a large number of patients. "

(3) Rotator Cuff Repair Published Evidence on Factors Associated With Repair Integrity and Clinical Outcome

Rotator cuff tears are common, and rotator cuff surgery represents a major health care expense.  Rotator cuff repairs are commonly performed: well over 200,000 per year in the U.S. The direct costs of these repairs are estimated a $3 to 12 billion per year in direct costs alone. While patients often benefit from rotator cuff surgery, anatomic failure of the repair is not unusual. These authors sought to identify the published evidence on the factors associated with retears and with suboptimal clinical outcomes of rotator cuff repairs.

They identified 2383 articles on rotator cuff repairs published between 1980 and 2012. Only 108 of these articles, reporting on over 8011 shoulders, met the inclusion criteria of reporting quantitative data on both imaging and clinical outcomes after rotator cuff repair. From these articles they extracted data relating to the patients, their shoulders, the procedures, and the results.

One of the most interesting findings in this paper is that while the number of articles meeting the inclusion criteria per year increased ten fold from the 1990s to 2012, the retear rates and clinical outcomes did not change significantly over this time interval (see the figure below).

The weighted mean retear rate was 26.6% at a mean of 23.7 months after surgery - an annualized failure rate of over 13% per year. Retears were associated with more fatty infiltration, larger tear size, and advanced age.

Clinical improvement averaged 72% of the maximum possible improvement.

Patient-reported outcomes were generally improved whether or not the repair restored the integrity of the rotator cuff.

Unfortunately, the inconsistent and incomplete data in the published articles limited the opportunity to conduct a meta-analysis of the influence of factors such as repair technique on the clinical outcome of rotator cuff repair.

The authors concluded that in spite of a dramatic increase in the number of publications per year, there is little evidence that the results of rotator cuff repair are improving. They suggest that in order to accumulate the evidence necessary to inform practice, future clinical studies on the outcome of rotator cuff repair must make available the important data relating to each patient’s condition, the surgical technique, the outcome in terms of integrity, and the change in patient self-assessed comfort and function. These data, will, in turn, enable meaningful meta-analyses of the influence of the details of the cuff pathology (size, chronicity, nature of injury), patient factors (age, gender, co-morbidities) and repair and rehabilitation approaches on the clinical and anatomic outcome. of cuff repair surgery.

This paper again surfaces the question of why anatomically unsuccessful cuff repairs can be associated with clinical improvement after surgery. In that retears were associated with more fatty infiltration, larger tear size, and advanced age, patients with these characteristics may want to consider non-repair options for managing their cuff tears.

Comment: So where does that leave us?
(1) In degenerative two tendon tears, there's plenty of time to implement a non-operative program of gentle stretching exercises and activity modification.
(2) For many patients with degenerative "massive" tears and symptoms refractory to non-operative management, the best rotator cuff surgery may not be a repair, but rather a 'smooth and move' procedure that avoids the prolonged period of protection required after a repair attempt for such a tear and avoids the risk of repair failure.


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