Showing posts with label discordance. Show all posts
Showing posts with label discordance. Show all posts

Monday, October 24, 2016

Rotator cuff sugery in patients over 75 years - is it worth it?

Rotator cuff surgery in patients older than 75 years with large and massive tears


These authors evaluated 64 elderly patients who underwent rotator cuff repair for large and massive rotator cuff tears. Repair was effected using a double mattress technique followed by a three month postoperative rehab program. An abduction brace was used for 7 to 8 weeks. The patients started passive forward elevation on the first postoperative day. After 4 weeks, pulley exercises to gain full forward elevation were started. Strengthening of the rotator cuff and periscapular muscle and wall pushups were started immediately after removal of the shoulder abduction brace at postoperative week 8. Posterior capsular stretching exercises and internal rotation stretching were initiated after approximately 3 months of strengthening exercises.



The mean postoperative follow-up period was 30.2 ± 5.2 months (range, 24-60 months). 80% were satisfied with their results. 26% had retears by MRI.

The authors concluded that "surgical treatment for large to massive rotator cuff tears in elderly patients with American Society of Anesthesiologists grade <4 provides good functional outcomes without morbidity, even in those with retears".

Comment: The results of patients with retears were essentially the same as those with intact repairs. The chart below compares the preoperative (pre) and postoperative (post) values for the intact and failed repairs.

It is interesting that the improvement in range of motion was better for those shoulders with failed repairs, as shown in the graph below that shows the change in the different parameters after surgery.

This study, like many before it, make us wonder about the indications and the benefit of a repair surgery with a prolonged rehabilitation program - especially in older individuals.

We find that many of these individuals are well served by a smooth and move procedure (see this link).


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Monday, May 2, 2016

Rotator cuff repair reinforcement with extracellular matrix graft - does integrity matter?

A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix.

These authors studied  61 shoulders with large repairable rotator cuff tears (3 to 5 cm). The rotator cuff tears were surgically repaired and reinforced with a extracellular matrix (ECM) xenograft. The average patient age was 56 years (range, 40-69 years). The average tear size was 3.8 cm.  Double row cuff repair was performed by minimally invasive open technique.  The graft was cut to overlap the completed repair of the rotator cuff covering the entire repair and was attached medially using a modified Mason-Allen technique.

Functional outcome scores, isometric muscle strength, and active range of motion were significantly improved compared with baseline. 
Magnetic resonance imaging at 12 months showed retorn rotator cuff repairs in 33.9% of shoulders, using the criteria of a tear of at least 1 cm, and tears in 14.5% of the shoulders using the criteria of retear >80% of the original tear size. Three patients underwent surgical revision. Complications included 1 deep infection.

Comment: While the absence of a comparison group treated without ECM does not allow determination of the value (benefit/cost) of the ECM in comparison to double row repairs performed without graft, the results are interesting in two particular regards. First the retear rates did not increase between 6 and 12 months. 


Second, the clinical outcomes showed the same amount of improvement whether or not the cuff repairs remained intact or retore as shown below.




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Friday, January 8, 2016

Rotator cuff repair - what is the retear rate and does a retear affect the clinical outcome?

Early postoperative repair status after rotator cuff repair cannot be accurately classified using questionnaires of patient function and isokinetic strength evaluation.

These authors sought to determine whether the clinical condition of shoulders 16 weeks after arthroscopic supraspinatus repair was affected by the integrity of the repair. 

In 60 patients they compared the Sugaya MRI rotator cuff classification system for cuff integrity to the Oxford Shoulder Score, 11-item version of the Disabilities of the Arm, Shoulder and Hand, visual analog scale for pain, 12-item Short Form Health Survey, and isokinetic strength. 

64% of the repairs had retears 4 months after surgery. They found no differences in the clinical or strength measures between intact repairs (Sugaya grade 1) and partial-thickness retears (Sugaya grades 2 and 3).

Comment: So, once again, we see (1) a very high rate of failure of rotator cuff surgery to durably restore the integrity of the cuff and (2) a lack of correlation between cuff integrity and clinical outcome.
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Sunday, October 18, 2015

Rotator cuff repair - effect of platelet rich plasma

Efficacy of platelet-rich plasma in arthroscopic repair of full-thickness rotator cuff tears: a meta-analysis.

These authors used a systematic review to compare the clinical improvement and tendon-to-bone healing with and without platelet-rich plasma (PRP)* therapy in arthroscopic rotator cuff repair. They reviewed clinical scores such as the Constant score, the American Shoulder and Elbow Surgeons score, the University of California at Los Angeles (UCLA) Shoulder Rating Scale, the Simple Shoulder Test, and the failure-to-heal rate by magnetic resonance imaging between PRP+ and PRP- groups. The five included studies were randomized controlled trials with a high level of methodologic quality in which 303 patients were enrolled.

Their analysis of the five Level I studies found no statistically significant differences between PRP+ and PRP- groups for overall outcome scores (P > .05). However, the PRP+ group exhibited better healing rates postoperatively than the PRP- group (P = .03) in small/moderate full-thickness tears  but there was no difference in severe-to-massive tears.

* a sample of autologous blood with concentrations of platelets above baseline values

Comment: There continues to be major interest in the use of platelet-rich plasma to augment the healing of soft tissue repairs. This is a carefully done study of five high-quality randomized trials. As we've seen before, the results suggest that cuff integrity after repair does not correlate well with the clinical course after attempted cuff repair.

The manuscript does not present data on the incremental cost of PRP treatment.

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Friday, July 31, 2015

"Rotator cuff repair" "You keep using that word. I do not think it means what you think it means."

One of my colleagues loves this quote of Inigo Montoya in the Princess Bride: "You keep using that word. I do not think it means what you think it means."



Inigo was referring to the word "Inconceivable", but this quote may also apply to arthroscopic rotator cuff repair.

According to a recent article, Characteristics of clinical shoulder research over the last decade: a review of shoulder articles in The Journal of Bone & Joint Surgery from 2004 to 2014, the most cited article on clinical shoulder research was "The Outcome and Repair Integrity of Completely Arthroscopically Repaired Large and Massive Rotator Cuff Tears"

The authors of this most cited article evaluated 18 patients who had complete arthroscopic repair of a tear measuring >2 cm in the transverse dimension at a minimum of twelve months after surgery and again at two years after surgery. The evaluation consisted of a standardized history and physical examination as well as calculation of the preoperative and postoperative shoulder scores according to the system of the American Shoulder and Elbow Surgeons. The strength of both shoulders was quantitated postoperatively with use of a portable dynamometer. Ultrasound studies were performed with use of an established and validated protocol at a minimum of twelve months after surgery.

Recurrent tears were seen in seventeen of the eighteen patients. Despite the absence of healing at twelve months after surgery, thirteen patients had an American Shoulder and Elbow Surgeons score of >/=90 points. Sixteen patients had an improvement in the functional outcome score, which increased from an average of 48.3 to 84.6 points. Sixteen patients had a decrease in pain, and twelve had no pain. Although eight patients had preoperative forward elevation to <95 degrees, all eighteen regained motion above shoulder level and had an average of 152 degrees of elevation. At the second evaluation, a minimum of twenty-four months after surgery, the average score, according to the system of the American Shoulder and Elbow Surgeons, had decreased to 79.9 points; only nine patients had a score of >/=90 points, and six patients had a score of </=79 points. The average forward elevation decreased to 142 degrees.

They concluded that arthroscopic repair of large and massive rotator cuff tears led to a high percentage of recurrent defects. The minimum twelve-month evaluation showed excellent pain relief and improvement in the ability to perform activities of daily living despite the high rate of recurrent defects; however, at a minimum follow-up of two years, the results deteriorated with only twelve patients who had an American Shoulder and Elbow Surgeons score of >/=80.

Comment: This sentinel article taught us that "repair" doesn't always mean what we think it does. Durable rotator cuff repair did not occur in many of these patients despite improvement in clinical outcome. Thus, improved clinical outcome cannot be used to judge the success of a surgical attempt to reattach the torn tendon to the tuberosity. This fact is echoed in many other articles, as shown in this post.

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Sunday, June 14, 2015

Rotator cuff repair - are graft patches of value to the patient?

Treatment of massive and recurrent rotator cuff tears augmented with a poly-l-lactide graft, a preliminary study.

These authors reported on 16 patients with repair of  two tendon tears augmented with a  poly-l-lactide synthetic polymer. Two patients required the patch to bridge defects, and 1 patient retore after a motor vehicle accident and had revision surgery at another institution. The 13 remaining patients were retrospectively evaluated from 1.2 to 1.7 years (average, 1.5 years) after surgery.  Five patients (38%) had an intact rotator cuff according to MRI at the time of follow-up. The remaining patients (62%) had full-thickness tears. 

The authors do not indicate that the clinical results correlated with the integrity of the repair.

A prior related post can be found here.

Comment:
The authors do not present data on the incremental cost of this device - either in terms of the cost of the device itself or the time necessary to implant it. Many previous reports of cuff repair have presented improvements in clinical measures even though the surgery failed to achieve integrity of the rotator cuff repair. This study does not demonstrate that this graft has value to the patient.

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Saturday, December 13, 2014

What factors favor healing of a rotator cuff repair?

Factors affecting rotator cuff healing.

These authors conducted a current concepts review of factors affecting healing of full thickness cuff repairs.

They point out that the integrity of the rotator cuff after repair surgery can only be ascertained if reliable advanced imaging shows a continuous layer of tissue from the muscle to the insertion on the tuberosity. Comment: This may not actually be the case. See this post for a discussion of failure in continuity.

Outcome measures that include measurements of strength or active motion (such as the Constant and UCLA scores) show higher scores when the tendon remains intact, whereas those scores based on patient-reported outcomes tend not to show a difference in outcome between intact and failed repairs - i.e. the patient perceived function is not affected by tendon healing.

In the authors' assessment of the literature the following factors did not affect the healing rate:
*open vs. arthroscopic repairs, 
*single vs. double row repairs, 
*medial vs. lateral knot placement, 
*suture anchor type, 
*type of tuberosity preparation, 
*acromioplasty, 
*structural augmentation,
*platelet rich plasma or fibrin matrix
*early vs. late motion

Healing rate was influenced by
*patient age
*tear size
*bone mineral density
*fatty infiltration
*amount of tendon retraction
*atrophy

Comment: What is interesting about the two lists above, is that the first (those factors unassociated with healing rate) are those under the control of the surgeon while the second (those factors associated with healing rate) are not under the surgeon's control. When we discuss with a patient the likelihood of a successful surgical repair we review the 'encouraging' and 'discouraging' factors as shown here.  If the chances of a durable repair seem slim, we explain that we favor a smooth and move procedure, avoiding the protracted down time necessary to protect a surgical repair. The smooth and move has also proved to be effective in the management of failed cuff repairs.

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Saturday, December 6, 2014

'Better functional outcomes were noted in patients who had re-torn their cuffs' - how's that again?

The influence of intraoperative factors and postoperative rehabilitation compliance on the integrity of the rotator cuff after arthroscopic repair.

These authors sought to determine when cuff re-tear commonly occurs in the postoperative period and to investigate the clinical factors that might predispose to an early cuff re-tear. They reviewed 127 cases having arthroscopic repair for supraspinatus ± infraspinatus tears with serial ultrasound examinations at 6 weeks, 12 weeks, and 26 weeks postoperatively.

The mean age of patients was 60 years. The overall re-tear rate was 29.1%, most occurring in the first 12 weeks postoperatively (25.2%) but continuing into the second 12 weeks (3.9%).

The patient's postoperative compliance, primary tear size, tendon quality, repair tension, cuff retraction, and footprint coverage were significant prognostic factor for re-tearing. The patients were questioned by a nurse to determine their compliance with the postoperative rehabilitation protocol.

There was a significant association between the rate of cuff re-tears and patients’ compliance at each time period after surgery:



Poor compliance of patients was highest (17.3%) during the second 6 weeks postoperatively.

There was a trend of increasing percentage of cuff re-tear with increasing tear size, retraction, and repair tension. An increasing percentage of cuff re-tear was also noted with decreasing tendon quality and footprint coverage. However, in the  multinomial logistic regression analysis, only the postoperative compliance was significantly associated with the rate of retear.

In contrast to the patients with good compliance, the relative risk ratio of retear in poorly compliant patients was 152 times higher at 6 weeks, 7 times higher at 12 weeks, and 39 times higher at 26 weeks.

At 12 weeks the Oxford score demonstrated a statistically significant increase in the patients with re-tears than in those with intact cuffs. There were no other differences in functional outcome between the shoulders with intact or failed repairs.



The authors concluded that "Better functional outcomes were noted in patients who had re-torn their cuffs at the 12-week period (Oxford mean scores, P 04)."  and "an early significant improvement of the clinical outcome should be a warning sign to a surgeon that the patient's compliance may be suboptimal, resulting in an increased risk of the cuff's re-tearing."

Comment: Their 29% retear rate is consistent with that in our recent review of the literature.
The fact that repairs are continuing to fail at 26 weeks after surgery brings into question the assumption made in an article on the economics of cuff repair that folks return to work 6 weeks after cuff repair.

While the focus of this article is on the relationship between compliance and cuff integrity, it seems that the real message is that there the clinical outcome as reflected by the Oxford Score is no better for intact than for retorn rotator cuff repairs. This makes us reflect on the clinical value of repair and of compliance with the postoperative rehabilitation program.

The improved clinical scores at 12 weeks in retorn repairs may be due to stress relaxation.

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Sunday, June 1, 2014

Does rotator cuff repair integrity influence the clinical results?

Factors associated with clinical and structural outcomes after arthroscopic rotator cuff repair with a suture bridge technique in medium, large, and massive tears

These authors evaluated 147 patients after arthroscopic rotator cuff repair using the suture bridge technique. An abduction brace was used for 4 to 6 weeks postoperatively. For the ensuing 6 weeks, "active motion of the shoulder was slightly increased".

25 (17.0%) shoulders had retears. Larger intraoperative tear sizes were correlated with higher retear rates. The incidence of retear was also higher in cases in which the preoperative fatty degeneration grade was higher. The retear rate was 10.6% (10 of 94) in medium tears, 18.4% (7 of 38) in large tears, and 53.3% (8 of 15) in massive tears. A larger intraoperative tear size was associated with higher rate of retear (P < .001). The heavy workers returned to work at an average of 3.2 months (range, 2-6 months) postoperatively with a retear rate of 18.7% (14 cases).

"Clinical symptoms improved regardless of structural status, which is similar to the findings of other studies."

Comment: Indeed. Using their data, we compared the functional outcome scores reported for the retear group and the overall group. As the graphs shown below demonstrate, the clinical results for the return repairs were not substantially different from those of the overall group. These data make one wonder whether the effort, time and cost expended to regain cuff integrity in cuff repair and post surgical rehabilitation is merited by the clinical results, especially in larger, chronic tears.






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Friday, April 25, 2014

Rotator cuff repair - retears and clinical outcomes

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

Rotator cuff tears are common, and rotator cuff repair represents a major health care expense. While patients often benefit from rotator cuff repair, 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.

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.


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Tuesday, February 25, 2014

Rotator cuff repair - does it matter if it works?

Structural Integrity After Rotator Cuff Repair Does Not Correlate with Patient Function and Pain: A Meta-Analysis

This article comes to a conclusion similar to that of an article by Doug Harryman published two decades ago and discussed in previous posts, such as this one. Other similar posts on the discordance between clinical outcome and retear can be found here.

The authors conducted a systematic review and a meta-analysis of studies that compared the clinical outcome with the structural integrity of the repair. 

They found only 14 studies that met their inclusion criteria. Of 861 patients in the included studies, 187 (>20%)  had failure of healing or retear of the rotator cuff repair. The size of the repaired cuff tear did not appear to affect the rate of retearing. 

Clinical outcome (as reflected by the University of California Los Angeles shoulder score, the Constant score, and the American Shoulder and Elbow Surgeons score  and the visual analog scale score) were improved whether the repair was intact or not.

The authors concluded that " The results of this meta-analysis demonstrate that the structural integrity
does not correlate with a clinically important difference in patient function and pain relief after rotator cuff repair." and " data from this meta-analysis demonstrated that, on the basis of validated shoulder outcome measures after rotator cuff repair, no difference exists in patient pain or function regardless of the structural integrity of the repair."

Comment: It is of interest that the average patient in this series was relatively young (58.5 years) and the average tear size was relatively small (2.68 cm). Thus one might expect that the post operative retear rates would be greater in older patients with larger tears. The minimum time from repair to postoperative imaging was 6 months; it seems likely that the retear rate would increase with time after repair. Thus the rates of retear may be underestimated.

This paper presented the results in terms of the scores and strength after surgery. Patients have surgery to improve their comfort and function; thus would have been more informative to see the results expressed as the amount of improvement in function and strength in the intact and retorn shoulders. In this way one can include the preoperative as well as the postoperative status so that the benefit of treatment is apparent, assuring that those patients with better scores after treatment did not have better scores before treatment. For measuring improvement, we prefer to assess the amount of improvement as a percent of the maximal possible improvement or the  IMPI as shown here.

The observation, made repeatedly by many authors, that shoulders with cuff tears are improved whether or not a surgical repair attempt is successful makes us question the value of rotator cuff repair surgery and prolonged restricted activity after repair in larger chronic cuff tears. When a durable repair seems unlikely we consider a smooth and move surgery that avoids the prolonged postoperative protection required after a cuff repair.

It also makes one wonder about the assumptions that went in to the paper concluding that across the board rotator cuff repairs save the country money.

Finally, in view of these results it is apparent that studies comparing methods of cuff repair need to be done very carefully in order to determine the value of one technique in comparison to another.

In this context, readers will be interested in this recent randomized study comparing non-operative management, acromioplasty and cuff repair in the treatment of non-traumatic cuff tears.

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Monday, January 20, 2014

"Patients treated with rotator cuff repair do well regardless of the integrity of the repair" - what does this tell us?

Factors Affecting Satisfaction and Shoulder Function in Patients with a Recurrent Rotator Cuff Tear

The authors of this article open with the statement that "It is widely accepted that most patients treated with rotator cuff repair do well regardless of the integrity of the repair." This statement again makes us question whether the anatomic success of cuff repair is important to the quality of the clinical outcome.  The purpose of this cross-sectional study was to reexamine this concept and identify the factors affecting the outcomes of patients with a recurrent tear. This study is similar to that which was the subject of yesterday's post.

Reestablishing cuff integrity is challenging. As pointed out in a prior post (which includes a Robert Frost poem), we have to thank the late Doug Harryman for first showing that cuff repair integrity was not essential to a good outcome from cuff repair surgery and showing us that it may not be in the best interest of the patient to perform a cuff repair and implement a prolonged period of restricted activity to protect the repair unless the conditions are optimal for healing of the repair. "When to repair and when to do a smooth and move?", that is the question.

The authors reviewed 180 patients who had cuff repair from 2007 to 2011 who met inclusion criteria among which there were 47 (26%) patients with full thickness retear. Functional outcomes were poorer for those having full thickness retears, but not those having attenuated or partial thickness defects. In patients with retears, clinical outcomes were better in patients over 65 years of age, whereas age did not significantly correlate with the clinical outcome in the patients with no retear.

Patient factors had a strong influence on the clinical outcomes in the patients with retears. Multiple regression analysis of the retear group showed that
(1) lower education level and a Workers’ Compensation claim were independent predictors of a poorer satisfaction score;
(2) lower education level, younger age, and a Workers’ Compensation claim were independent predictors of a poorer ASES score; and
(3) lower education level was an independent predictor of a poorer SST score
Furthermore, those patients who had retired for reasons other than illness demonstrated better clinical outcomes than those who were unemployed or disabled.

When we discuss the 4 Ps that influence the outcome of treatment (problem, patient, physician, and procedure), age, Workers' Compensation and lower education levels are great examples of the 'patient' factors that are known to influence the clinical outcome of treatment. It is desirable to include each of the 4 Ps in studies of clinical outcome (e.g. did the size of the tear or the type of repair affect clinical outcome in this series?). It would have been really interesting if the authors had performed a multiple regression analysis to determine how important cuff integrity was to the clinical outcome so that we could be sure that poor outcomes were not related to lower education level, Workers' Compensation claim and young age rather than to retear.

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