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).

Glenoid component fixation: why go "cementless"?

Clinical and radiographic outcomes of an all-polyethylene fluted central peg glenoid component, implanted utilizing an off-label, uncemented technique, at a minimum 5-year

These authors sought to evaluate the clinical and radiographic results of a fully uncemented all-polyethylene fluted central peg bone-ingrowth glenoid component at a minimum 5-year follow-up.

The study included 35 shoulders in 31 patients (mean age, 73 years) with a mean follow-up of 100 months (8.3 years). The study included  patients presenting with avascular necrosis or primary osteoarthritis excluding patients with glenoid type C. The glenoid types for the included shoulders are not reported. Patients having an impaired functional outcome due to medical conditions were excluded. The components were inserted using an off-label technique without the cement fixation of the peripheral pegs as recommended by the manufacturer. The rationale for this technique was "potentially reducing heat-induced necrosis, having a shorter operating time, and potentially reducing cement-related difficulties in case of revision".

The mean Constant score improved from 40 preoperatively to 74 at early followup dropping to 66 at final followup. The drop in CS over time was attributed primarily to a decrease in strength at the later time points.

CT scans found an initial osseointegration rate of 81% at early follow-up that decreased to 71% at a mean follow-up of 8.4 years. 7 shoulders demonstrated isolated radiographic loosening around the central peg. 3 shoulders demonstrated isolated radiographic loosening around the peripheral pegs, and 1 shoulder with gross radiographic loosening demonstrating a combined loosening of all pegs. 74% (26 of 35) of the shoulders demonstrated progression of radiolucent lines.  The radiographic loosening rate was 31%.

Of the 35 shoulders, 4 (12%) required revision. Two patients were revised because of symptomatic loosening, 1 patient underwent a revision because of a subscapularis insufficiency, and 1 patient was revised because of a  Cutibacterium infection.

Comment: This is an interesting study with CT scans evaluating the glenoid component fixation at early and intermediate time points after total shoulder arthroplasty using an off-label technique.

The 12% revision rate at 8 years in this study can be compared to the 3% revision rate at 8 years for cemented all-polyethylene (cross linked) components reported by the Australian Orthopaedic Association (see below).

These results can also be compared to those of Noyes et al (see this link) with similar length of followup. In the Noyes study of 76 total shoulders using the same glenoid component as in this study, but inserted with cementing of the peripheral pegs as recommended by the manufacturer, there was 97% survivorship at 80 months. On radiographs, 81% of the central fluted pegs had complete incorporation with no lucent lines.

Cemented fixation of this component has shown great clinical utility in a large international study (see this link).

Thus it does not appear that using an off-label cementless insertion technique is an attractive method for glenoid arthroplasty.

To see a YouTube on how we do total shoulder arthroplasty with an emphasis on glenoid preparation, click on this link.

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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'