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Read Original Release

Study of 20 men too small to claim ‘long-term improvement’ after rotary cuff repair

Good long-term improvement after 'reverse' shoulder replacement in patients under 60

Our Review Summary

This release explains the results of a very small retrospective study that looked at the long-term results of reverse shoulder replacement (RSA) surgery in adults under 60 years old.  Previous studies had suggested that such surgeries weren’t recommended for younger adults, but this release claims the new study shows that they are.

It provides numerical data showing improvement among study participants, although much of that is subjective and points out the negative outcomes from the study.  It makes no mention of the cost of such procedures, which can range from $7,000 to more than $20,000.  It also omits who funded the study and doesn’t state that the corresponding author has received payment from replacement joint manufacturers.

 

Why This Matters

Shoulder injuries among adults, especially the elderly, can severely affect their quality of life and ability to participate in some activities. In general, those adults who remain active tend to be in better health so any procedures that may support that active lifestyle should be encouraged, assuming these results are borne out in subsequent larger studies.

Rotator cuff pathology will eventually affect almost everyone, but a very small percentage of people will develop unrepairable massive tears and have severe pain. The problem is especially unusual in the younger population, because the tears are related to degenerative tissue failing which usually occurs in an older population. In addition, progression to massive unrepairable tears occurs over time. RSA is a viable option in the over 60 group only when other soft tissue repairs to help stabilize the shoulder and resolve pain are not possible due to the nature of the residual rotator cuff tissue.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the cost of this surgical procedure in this news release.  A quick search online reveals that such procedures can range in cost from $7,000 to $21,000 while an average cited by a study from Johns Hopkins placed the typical cost at around $10,000.  Joint replacement operations are typically expensive and their costs should be provided in any story or news release promoting their use.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release does provide some numerical data on the benefits participants gained from the procedure:  “Patients’ ratings of ‘subjective shoulder value’ improved from 20 percent to 71 percent (compared to 100 percent for a normal shoulder).”  It also provided the following: “The average Constant score–a standard assessment accounting for shoulder motion, strength, daily activities, and pain–at the time of final-follow-up improved from 24 to 59 (out of a possible 100).”  But what readers don’t know — beyond the subjective views of participants — is how their shoulder movement improved in a practical sense.  Could they reach items on high shelves?  Could they play tennis, bowl or other athletic activities?  We have no way of knowing from the release if their quality of life improved, besides of course, the elimination of pain, which is itself an improvement.

The bigger picture is that with such a small group of patients, a 39 percent complication rate was very high. Twenty-five percent of the volunteers rated results as only fair. Further, range of motion deteriorated over time in all participants. The study results warrant further analysis with a prospective study to more accurately understand if this is a safe and effective procedure for the under-60 population.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release states, “However, complications occurred in 39 percent of the shoulders. Further surgery was required in six shoulders; in two cases, the RTSA procedure was considered a failure.”  It adds that, “When complications occurred, long-term shoulder functioning was not as good but even with the high complication rate, 72 percent of patients rated their satisfaction level as excellent or good.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Again, this a borderline judgement.  To its credit, the study does include the evaluation of patients for a long time, “between eight and 19 years after surgery” or an average of 11.7 years.”  However, the study only involved 20 patients (23 shoulders) and its findings conflict in some fashion with previous studies looking at long-term efficacy of using this surgical procedure. The headline and the lede of the release claim “good long-term improvement” and “lasting improvement in shoulder function” for patients less than 60 years old. That seems to be a very broad claim for a study based on only 20 patients.

This is a classic example of a small retrospective study being publicized as a justification for routine use of a procedure. The results were worth reporting simply because there has been general consensus that this procedure would not be appropriate for this younger population. The only applicable information that should be culled form this study is that RSA may be a successful procedure in the under-sixty patient population, but further prospective study needs to be performed to objectively determine the success before wide spread acceptance of this procedure.

Does the news release commit disease-mongering?

Satisfactory

The release does not commit disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The news release never mentions funding for this study, nor does it mention that the corresponding author has been paid by two joint replacement manufacturers, information that was readily available in the scientific paper.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

There’s no mention of any alternatives to this surgery in this release. This is surely something that should have been discussed. Alternative treatments such as superior capsular reconstruction should be considered prior to RSA, particularly for the patients with massive tears of the rotator cuff without signs of shoulder arthritis. Failures of RSA in a younger individual can be devastating, at times leaving individuals with no good options when the implant fails and the patient has lost a significant amount of bone related to the implantation of the prosthesis and destruction of bone that sometimes occurs with failure of the implant.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

Since the study is reporting the long-term results of this form of surgery in patients, readers can assume that it is available.

The implant is widely available to be used at the surgeon’s discretion.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release established novelty and earned a Satisfactory rating with this statement: “When first introduced, RTSA was performed mainly in elderly patients who placed low demands on the shoulder. With refinements in technique and components in more recent years, the procedure has been used in younger, more active patients. But there are concerns about how well the results of RTSA will hold up over time in this group of patients.”

However, with the limited number of patients involved in this study, and the fact its results conflict with some earlier research, this may not be a case where the findings warrant a news release, even though it is based on a peer-reviewed paper.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t make use of unjustifiable language.

Total Score: 5 of 10 Satisfactory

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