Reverse total shoulder arthroplasty - is its current use consistent with FDA's "Indications for Use"?

The Federal Drug Administration (FDA) oversees the approval of new drugs and devices for use on patients in the United States, defines the Indications for Use, and then labels the product with those indications. 

The FDA cleared the first reverse total shoulder arthroplasty (rTSA) for use in the United States in late 2003 (Delta Shoulder K021478; DePuy Inc., Raynham, MA, USA). The FDA approved on-label Indications for Use for rTSA at that time were limited to cuff tear arthropathy and revision surgery: “Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device" (see shoulder prosthesis, reverse configuration and FDA clearance).

After the clearance for rTSA use for rotator cuff tear arthropathy, surgeons began to use rTSA for off-label indications (i.e. those other than the original approved indications), such as osteoarthritis without rotator cuff tear, massive cuff tear without osteoarthritis, proximal humerus fractures, tumor, inflammatory arthritis, and chronic glenohumeral joint dislocation. Since 2006,  some devices were subsequently cleared by the FDA for use in proximal humeral fractures and other indications; on the other hand, some reverse shoulder devices remain cleared only for the initial indications. 

The authors of Off Label use of Reverse Total Shoulder Arthroplasty: The American Academy of Orthopedic Surgeons Shoulder and Elbow Registry evaluated the trends for the rTSA in the United States with respect to those uses that were consistent with the original FDA approval and those which were "off label". They analyzed 3850  rTSA procedures reported to the AAOS shoulder and elbow registry from Jan 2015-Mar 2021.

 
They found that only 24.4% of rTSA surgeries were performed for original on-label use (rotator cuff tear arthropathy). Off-label use of rTSA was seen in 75.6% of cases. Furthermore, they found that off-label use is increasing over time while on-label use is decreasing.

When reviewing those rTSA done off-label, the majority (41.4%) were done for osteoarthritis without cuff tear. Other off-label rTSA use included 15.1% for cuff tear without arthritis, 13% potentially off-label for proximal humeral fractures, 4.6% for inflammatory arthropathy and 1.6% for glenohumeral dislocation. 

The authors point out that "some implant manufacturers have expanded indications for rTSA without providing clinical data to support changing FDA approved Indications for Use. They presented the table below showing the approved and unapproved indications for different implants.

"Only 10-15% of the 510(k) premarket notification applications are supported by clinical data. The incremental expansion of Indications for Use without supportive data, a practice known as predicate creep, is occurring with rTSA. Performing rTSA for off-label indications may create liability risk for surgeons and implant manufacturers.".

The FDA does allow for some off-label use of devices stating: “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects”

Despite the leeway the FDA provides in permitting surgeons to use devices off-label under practice of medicine, surgeons in the United States may still be at risk for litigation when using rTSA for an off-label indication, particularly if they have a financial relationship with the company or other conflict of interest, or the informed consent does not document that the off label use of the device was discussed with the patient.

Comment: These authors conclude that the current Indications for Use of rTSA are confusing and not uniform among systems. They recommend that device manufacturers pursue labelling changes by the FDA supported by the clinical data needed to formally expand these indications.

See this related post discussing off-label use: Reverse total shoulder arthroplasty: trends and complications in ABOS board candidates

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Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link).
Shoulder rehabilitation exercises (see this link).

Superior capsular reconstruction - what are the indications?

The technique of Superior Capsular Reconstruction has been presented in a recent video (see this link).

  In this case injection of a bone marrow aspirate was added to the procedure

The costs of the procedure have been estimated in a recent article: Superior Capsular Reconstruction for Massive Rotator Cuff Tears A Critical Analysis Review

Comment: What remains to be clarified is the indications for this procedure. In the video, the patient had this history

 this physical exam

 these x-rays

 and these MRI's

In such a patient with 5-/5 strength of supraspinatus and 160 degrees of forward flexion, one might consider a less costly and less complicated procedure, the smooth and move (see this link), which enables immediate postoperative resumption of active use of the arm, rather than the more restrictive rehabilitation program described above. In order to determine the value of the superior capsular reconstruction, a controlled trial comparing these two approaches for patients with irreparable cuff tear and retained active elevation is needed.

The published early and longer term outcomes from the smooth and move procedure are summarized below.

Significant improvement in patient self-assessed comfort and function as early as six weeks after the smooth and move procedure for shoulders with irreparable rotator cuff tears and retained active elevation

These authors point out that it has been previously  documented that the smooth and move procedure—smoothing the proximal humeral surface while maintaining the coracoacromial arch—can provide clinically significant long-term improvement in function for patients having irreparable rotator cuff tears with retained active elevation (see previous blog post that is reproduced below).

In this study they sought to demonstrate that clinically significant gains in comfort, function, and active motion can be realized as early as 6 weeks after this procedure. They conducted a prospective cohort study of the 6-week clinical outcomes for 48 patients enrolled prior to a smooth and move procedure for irreparable rotator cuff tears. Prior rotator cuff repair had been attempted in 28 (70%).

In 40 patients with preoperative and 6-week postoperative measurements, the Simple Shoulder Test scores improved from an average of 3.4 ± 2.8 preoperatively to 5.7 ± 3.5 at 6 weeks (p < 0.001), an improvement that exceeded the published values for the minimal clinically important difference (MCID).

The clinical outcomes were not worse for the 18 shoulders with irreparable tears of both the supraspinatus and infraspinatus.

In 30 patients with preoperative and 6-week postoperative objective measurements of active motion, the average abduction improved from 93(± 43) to 123(± 47)° (p = 0.005) and the average flexion improved from 102(± 46) to 126(± 44)° (p = 0.023).

They concluded that in addition to its previously documented long-term effectiveness for shoulders with irreparable rotator cuff tears and retained active elevation, this study demonstrates that the smooth and move procedure provides clinically significant improvement as early as 6 weeks after surgery.

They present the case example of a 71 year old physician photographer with a failed prior cuff repair attempt. Here is the preoperative radiograph

At surgery he had no supraspinatus or infraspinatus. The debris shown below was removed from his humeroscapular motion interface

This video (used with permission of the patient) shows his function 6 weeks after surgery.

Eight weeks after surgery he was photographing north of the Arctic Circle. Here's one of his photos.

This study should be considered along with a prior study, which is discussed below.

Treatment of irreparable cuff tears with smoothing of the humeroscapular motion interface without acromioplasty

These authors sought to determine whether shoulders with irreparable rotator cuff tears and retained active elevation (>100 degrees) can be durably improved using a conservative surgical procedure that smoothes the interface between the proximal humeral convexity and the concave undersurface of the coracoacromial arch followed by immediate range of motion exercises.

The typical pathology in these cases is shown in the figure below.

The surgical approach is through a deltoid splitting incision that preserves the deltoid origin, the acromion and the coracoacromial ligament.

The coracoacromial arch is preserved to avoid the complication of anterosuperior escape that is commonly encountered when acromioplasty is performed in the presence of a large cuff tear.

The surgery includes smoothing of the prominence of the greater tuberosity that is exposed in cuff tears along with resection of adhesions in the humeroscapular motion interface and a gentle manipulation under anesthesia to resolve the stiffness that is commonly associated with chronic cuff tears. Immediate active assisted and active motion are encouraged immediately after surgery. Because no repair or reconstruction has been performed, activities, including deltoid strengthening can be resumed as soon as they are comfortable. 

They reviewed 151 patients with a mean age of 63.4 (range 40–90) years at a mean of 7.3 (range 2–19) years after this surgery. The patient data are shown below, contrasting the patients that did and did not improve by the MCID of 2 in the Simple Shoulder Test

In 77 shoulders with previously unrepaired irreparable tears, Simple Shoulder Test (SST) scores improved from an average of 4.6 (range 0–12) to 8.5 (range 1–12) (p < 0.001). Fifty-four patients (70%) improved by at least the minimally clinically important difference (MCID) of 2 SST points. 

For 74 shoulders with irreparable failed prior repairs, SST scores improved from 4.0 (range 0–11) to 7.5 (range 0–12) (p < 0.001). Fifty-four patients (73%) improved by the MCID of 2 SST points.

They provided this case example. A rancher in his mid 60s had a right rotator cuff reconstruction with freeze-dried acellular human dermal collagen tissue matrix that subsequently became infected. He presented to us with a painful stiff right shoulder. At surgery there was extensive scar throughout the humeral scapular motion interface. The subscapularis was detached but was reconstructible. The supraspinatus was absent. The upper 2/3 of the infraspinatus was absent as well. The tuberosities were prominent. He had a smooth and move procedure at which time the abundant scar in the humeral scapular motion interface was debrided. The previous sutures and Graft Jacket were excised. The bursa was removed. The prominent tuberosities were resected using a rongeur and a burr. A manipulation under anesthesia was performed to assure a full passive range of motion. Passive and active range of motion exercises were started immediately after surgery. Three years later he reported excellent shoulder comfort and function and sent us this photo of his return to one of his favorite activities

They concluded that smoothing of the humeroscapular interface can durably improve symptomatic shoulders with irreparable cuff tears and retained active elevation > 100 degrees. They point out that this conservative procedure offers an alternative to more complex procedures in the management of irreparable rotator cuff tears.

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages  arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Are surgeons doing too many reverse total shoulders?

Comparative Utilization of Reverse and Anatomic Total Shoulder Arthroplasty: A Comprehensive Analysis of a High-volume Center

These authors conducted  a single-center retrospective review of 1,600 primary anatomic total shoulders (TSAs) and 1,192 reverse total shoulders (RTSAs).

During the decade between 2005 and 2015, RTSA increased from 27% to 52% of the shoulder arthroplasties. The number of RTSAs performed for osteoarthritis and irreparable rotator cuff tears increased, and the proportion of RTSAs performed for rotator cuff tear arthropathy decreased.

Comment: Let's first consider the relative economics (reference Orthopaedic Network News)

From these data we see that the average selling price of a reverse is 60% of the medicare payment to the hospital, whereas the average selling price of an anatomic total shoulder is 41%.  Surgeons should review with their hospitals the effect of implant choice on the ability to cover the costs of patient care.

Let's next consider the effect of the aTSA vs RTSA decision on the patient, take for example a 72 year old active man with capsulorrhaphy arthropathy and these x-rays (no CT scan needed!).

who was treated with a standard total shoulder - two year post op films shown below

He recently wrote: "Greetings from Alaska! It's coming up on the end of two years since my shoulder surgery. I just wanted to express to you my deepest thanks for a job well done. My only regret is that I did not find you sooner! Unfortunately with my experience and disappointment with the original surgery 20 plus years ago, it put me off  and influenced my decision to wait so long! I had almost giving up on any normal active life that I had been so used to before that surgery (an instability repair)!

Since my surgery , I have traveled and I still fly my airplane! I have killed a moose to help put meat in our extended families' freezers and I have fly fished and fished salmon and halibut to my heart's content without any discomfort whatsoever. In general, I seem to have no problems with any other recreational activity or physical activity! 

Thank you for going with the traditional total replacement surgery and not going with a reverse replacement as had been suggested by three other surgeons! I am forever grateful for how it all turned out - you have given me my life back! "

The point is that three prior surgeon had tried to convince him to have a reverse, but he was unwilling to accept the limitations.

Thirdly, as the authors of this paper point out, "  few long-term outcomes studies are available, and they suggest that functional survival after RTSA at 10 years may only be 58% to 76%" While they report a trend to performing RTSA in younger patients, younger patients are reported to have higher revision rates and higher rates of unsatisfactory results.

Finally and most importantly, the trend toward increasing volumes of RTSAs does not indicate that this is best treatment for conditions such as osteoarthritis (see case example above). It would seem that these authors are in a great position to compare cost and outcome data for anatomic TSA and RTSA stratified by diagnosis, age and sex, but these data are not presented. We hope that this information will be forthcoming.

In our practice we use RTSA only when it is clearly the best option: pseudoparalysis, anterosuperior escape, and complex proximal humeral fractures. For many other diagnosis, there are safer and less costly approaches that enable higher levels of activity.

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Total shoulder arthroplasty in patients with HIV - when does it make sense?

Total shoulder arthroplasty in patients with HIV infection: complications, comorbidities, and trends.

These authors identified 2528 HIV-positive patients who underwent TSA or reverse TSA (RTSA) in the 2005 to 2012. Medicare database. 1353 patients had 2-year follow-up. The percentage of TSA/RTSA done for HIV positive patients is on the increase

These patients had a higher prevalence of comorbidities. 

These patients had significantly higher rates of 7 to 30 medical complications

Particularly impressive was the 45 times higher risk of stroke CVA.

 In addition to the medical complications,  HIV-positive patients had higher overall rates surgical complications, including broken prosthetic joints (OR, 1.72; CI, 1.20-2.47), periprosthetic infection (OR, 1.36; CI, 1.01-1.82), and TSA revision or repair (OR, 2.44; CI, 1.81-3.28).

Comment: These data remind us that shoulder arthroplasty is in almost all cases and elective procedure. The 'indications' for these procedures are not 'arthritis' or 'cuff tear arthropathy' but rather a patient who has a good chance of benefitting from the surgery, considering not only the shoulder pathology but also the risk factors for complications and poor results. We need to be prepared for the situation where the shoulder 'needs' surgery, but the patient doesn't.

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Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book.

Click here to see the new Rotator Cuff Book

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

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Reverse total shoulder - It is time to re-examine which patients are receiving it.

Reverse shoulder arthroplasty for massive rotator cuff tear: risk factors for poor functional improvement.

These authors reviewed their cases of primary RSA performed for massive rotator cuff tear without glenohumeral arthritis with minimum 2-year follow-up.

Poor outcomes were were defined as Simple Shoulder Test (SST) score improvement of ≤1, whereas controls improved SST score ≥2. Risk factors were chosen on the basis of previous association with poor outcomes after shoulder arthroplasty. Latissimus dorsi tendon transfer results were analyzed as a subgroup. Value was defined as improvement in American Shoulder and Elbow Surgeons (ASES) score per $10,000 hospital cost.

In a multivariate binomial logistic regression analysis, neurologic dysfunction (P = .006), age <60 years (P = .02), and high preoperative SST score (P = .03) were independently associated with poor functional improvement. Latissimus dorsi tendon transfer patients significantly improved in active external rotation (-0.3° to 38.7°; P < .01). The value of RSA (ΔASES/$10,000 cost) for cases was 0.8 compared with 17.5 for controls (P < .0001).

The authors emphasize the critical importance of patient selection.

Comment: We are in an era where surgeons are rapidly explaining the indications for RSA - a procedure originally developed for rotator cuff tear arthropathy (cuff deficiency + arthritis) with pseudo paralysis. Now surgeons are using RSA for cuff disease without arthritis and for osteoarthritis with biconcave glenoids. The average age of patients receiving this surgery is becoming younger and younger. And the severity of preoperative shoulder impairment is becoming less and less.

We were not sure from what populations the 'cases' and 'controls' were selected - for example were they from the same time period? Did the 'control' group include all the patients from this period? What percent of the RSAs done during this period were failures? Without this information can we be sure that this was an appropriate comparison. Nevertheless, we value this effort to define 'failure' as lack of clinical improvement (rather than complications or revisions) and to use data to rein in the exploding number of reverse total shoulders performed each year. 
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Use the "Search" box to the right to find other topics of interest to you.


You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

See the countries from which our readers come on this post.

Rotator cuff tears - ?appropriate use criteria? AAOS

According to the AAOS website, The AAOS Board of Directors has approved new appropriate use criteria (AUC) on "Optimizing the Management of Full-Thickness Rotator Cuff (RC) Tears." This is the second AUC released by AAOS, and is supported by both a written document and the AAOS mobile-optimized AUC web app. The AUC is based on a systematic review of the literature as well as clinician expertise from several specialties. It covers five treatments—nonsurgical modalities, partial repair and/or debridement, repair, reconstruction, and arthroplasty—and presents 432 different patient scenarios to help clinicians identify for whom and when the treatments are appropriate.

It is very entertaining to play with their app.

We tried two scenarios, both of a patient with moderate symptoms, ASA 2, no factors that would interfere with healing or the outcome, both with moderate sized tears and small amounts of fatty infiltration. Let's say that the patient was 'some better' with non-surgical management. In the first scenario the surgeon enters that the patient had responded to previous treatment - the result is that non-operative treatment is appropriate. In the second, the surgeon enters that the patient had not responded to previous treatment - the result is that the appropriate treatment is repair. Thus one small change in the response justifies surgery...is it really that simple? We encourage you to 'play' with this app and see if the 'appropriate use' recommendations make sense to you.

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Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

See the countries from which our readers come on this post.