In writing this review, our friend and colleague, Bill Levine, from the New York Presbyterian/Columbia University Medical Center posed some important questions. We've attempted to provide some helpful responses here.
(1) What was the overall duration of followup?
Response: In a clinical study such as ours, patients have their surgery on a wide range of dates. In this study we provided all of the followup data we had on all patients having surgery more than two years before the study. Some had much longer followup than two years as can be seen on this graph. The advantage of showing the data in this manner is that patients want to know not only how functional shoulders having had this procedure are years down the line, but also at what rate the recovery takes place.
(2) Longer-term follow-up of shoulder hemiarthroplasty has shown a decline in outcomes, so reporting the minimal clinically important different after only two years is not sufficient.
Response: We agree that long long term followup is the ultimate test - that's why we continue to follow patients over the long haul. Of course, the ream and run is not a just a hemiarthroplasty in that both sides of the joint are reshaped.
(3) Radiographs were used exclusively to determine glenoid morphology and wear patterns. Radiographs are inaccurate for determining these features and can underestimate the amount of glenoid wear. Although computed tomography scans do increase the radiation exposure for the patient, they also increase the ability of the surgeon to preoperatively determine whether this type of procedure is appropriate.
(3) Radiographs were used exclusively to determine glenoid morphology and wear patterns. Radiographs are inaccurate for determining these features and can underestimate the amount of glenoid wear. Although computed tomography scans do increase the radiation exposure for the patient, they also increase the ability of the surgeon to preoperatively determine whether this type of procedure is appropriate.
Response: While many surgeons prefer to obtain CT scans, accepting the increased radiation exposure, we find that carefully done plain radiographs give us the information we need for planning the procedure. Furthermore, we have found that the ream and run allows us to manage rather severe glenoid erosion.
(3) The authors presented a new formula for the determination of MCID that appears to be fairly robust but has not yet been validated, so further validation of this approach would be helpful for future publications and research.
Response: We found an inherent problem with the conventional application of the concept of minimal clinically important difference. As we explain our article, the literature suggests that the MCID for the Simple Shoulder Test is 2 or 3. However, the benefit to the patient depends on the functional status of the shoulder before surgery. For example, a shoulder with a preoperative SST of 2 has the potential to improve by 10 (the maximal SST possible is 12). So if it improves by 2, it improves by only 2/10 of the possible improvement. By contrast, a shoulder with a preoperative SST of 10 that improves by 2 realizes 100% of the possible improvement. For this reason we normalized the improvement by dividing it by the maximal possible improvement.
(4) Finally, another concern raised by this study is that the long-term impact of reaming the glenoid without prosthetic implantation remains unknown. Recent research from our laboratory has shown that there is a deleterious impact in removing too much cortical bone, which may lead to more prosthetic stress and subsidence (similar to findings in the hip arthroplasty literature), leaving one to question what will happen with longer-term follow-up of a prosthetic metal head on native bone.
Response: We agree that glenoid bone is precious and for that reason ream only enough to create a single concavity when we perform the ream and run. We have performed a study of the status of the glenoid after this procedure and did not find significant erosion with time.
(5) In summary, therefore, the ream-and-run procedure presented in this study has shown excellent short-term outcomes in older and less active male patients. Longer-term follow-up is necessary, however, before this procedure can be recommended for widespread use.
Response: We continue to follow our patients closely and, frankly, have been amazed by what they have been able to accomplish after this procedure - many are surely not 'less active'. See also here and here.
We are grateful to Bill Levine for his comments and appreciate the opportunity to respond here.
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