The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 94, Issue 21

Scientific Articles | November 07, 2012

Reverse Shoulder Arthroplasty for the Treatment of Rotator Cuff Deficiency: A Concise Follow-up, at a Minimum of Five Years, of a Previous Report*

Derek Cuff, MD¹; Rachel Clark, BA, CCRC²; Derek Pupello, MBA²; Mark Frankle, MD³

¹ Suncoast Orthopaedic Surgery & Sports Medicine, P.A., 836 Sunset Lake Boulevard, Suite A-205, Venice, FL 34292-7556
² Foundation for Orthopaedic Research and Education, 13020 North Telecom Parkway, Tampa, FL 33637
³ Florida Orthopaedic Institute, 13020 North Telecom Parkway, Tampa, FL 33637. E-mail address: frankle@pol.net

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Investigation performed at the Florida Orthopaedic Institute and the Foundation for Orthopaedic Research and Education, Tampa, Florida*Original PublicationCuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51.

J Bone Joint Surg Am, 2012 Nov 07;94(21):1996-2000. doi: 10.2106/JBJS.K.01206

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Abstract

Abstract:

We previously evaluated ninety-four patients (ninety-six shoulders) who underwent reverse shoulder arthroplasty with use of a central compressive screw along with 5.0-mm peripheral locking screws for baseplate fixation and a center of rotation lateral to the glenoid. The purpose of this study was to report updated results at a minimum follow-up of five years. Since the last report, an additional two patients underwent revision surgery: one for recurrent instability and one for resorption of a proximal humeral allograft. The patients continue to have improved outcome scores and range of motion. Survivorship with the end point being revision for any reason was 73.5 months, with 94% survival at sixty months. Radiographic follow-up showed that two (3%) of seventy-six patients included in the survivorship analysis had asymptomatic humeral loosening, seven (9%) had scapular notching, and no patient had glenoid baseplate loosening or baseplate failure. The patients have maintained their improved function with durable clinical and radiographic results at a minimum of five years.

Level of Evidence:

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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Background

Background | Methods | Results | Conclusions

We previously reported on a cohort of patients who were treated between February 2004 to March 2005 with a reverse shoulder arthroplasty (RSA) as a part of a United States Food and Drug Administration Investigational Device Exemption study¹. The implant utilized had a central compressive screw with 5.0-mm peripheral locking screws for fixation and a glenosphere with a center of rotation lateral to the glenoid (Reverse Shoulder Prosthesis, Encore Medical [dba DJO Surgical], Austin, Texas). The surgical technique placed the glenosphere with inferior tilt relative to the face of the glenoid by preferentially reaming the inferior aspect of the glenoid. The humeral component had a 135° neck-shaft angle and was placed in 30° of retroversion. The patients had end-stage rotator cuff deficiency due to a wide variety of pathologic disorders, including primary rotator cuff deficiency, failed previous rotator cuff repairs, failed previous arthroplasty, and proximal humeral nonunion.

At the minimum two-year follow-up point, these patients had significant preoperative to postoperative improvements in their clinical outcome scores and shoulder motion (p < 0.0001)¹. Radiographic analysis at that time revealed no scapular notching and no baseplate failures. The purpose of this study was to examine the midterm results at a minimum of five years of follow-up, focusing on survivorship of the implant, clinical outcomes, and radiographic findings.

Methods

Background | Methods | Results | Conclusions

Subsequent to our previous report, sixteen patients died and four were lost to follow-up, leaving seventy-four patients (seventy-six shoulders) for evaluation. With respect to preoperative indications for surgery, thirty-four of these shoulders had primary rotator cuff deficiency with accompanying arthritis, twenty-three shoulders had previous failed rotator cuff operations, and nineteen shoulders had a failed arthroplasty and cuff deficiency.

The average age of the remaining patients was 70.4 years (range, 51.7 to 88.0 years): fifty were females, and twenty-four were males. The average time to follow-up for this cohort was sixty-two months (range, sixty to seventy-nine months). The surgical technique and postoperative protocol for this procedure have previously been described in detail^2-4.

The patients were followed yearly, and the same clinical outcome scores (the American Shoulder and Elbow Surgeons [ASES] score and the Simple Shoulder Test [SST] score) that were utilized in our previous study were updated at the time of the last follow-up. Patient questionnaires included a self-assessment of shoulder motion as indicated by marking the highest attainable motion on a picture. This assessment varied somewhat from that used originally and reported in our initial two-year report, as some patients were not videotaped while performing a standard active range-of-motion protocol at the five-year follow-up point, but all were able to fill out the assessment form.

Radiographic analysis was performed by an independent observer in the same standardized fashion as we reported previously. Baseplate fixation was graded as stable (no evidence of radiolucency at the baseplate-bone interface or around any screw), at risk (>1 mm of circumferential radiolucency at the baseplate-bone interface or around any one screw), or loose (>1 mm of radiolucency around the baseplate-bone interface and around all screws or there was a shift in the position of the baseplate). Humeral loosening was measured with use of the grading system described by Sperling et al.⁵. Radiographs were also evaluated for dislocation, scapular notching on the basis of the criteria of Sirveaux et al.⁶, and screw breakage.

Statistical Analysis

Kaplan-Meier survivorship analysis was performed with use of SPSS version 19.0 software (SPSS, Chicago, Illinois), with the end point being revision surgery for any reason. Two of the sixteen patients who had died after the publication of the original study had undergone a revision procedure before death and were therefore included in the survivorship analysis. Preoperative and postoperative clinical outcome data were compared with use of a Wilcoxon signed-rank test (Minitab version 14.11.1; Minitab, State College, Pennsylvania).

Source of Funding

This study was supported in part by a research grant from DJO Surgical, Austin, Texas.

Results

Background | Methods | Results | Conclusions

Kaplan-Meier survivorship analysis, with the end point being revision surgery for any reason, revealed that the average survival time was 73.5 months (95% confidence interval [CI], 69.7 to 77.3), with 94% survival at sixty months (Fig. 1). A total of five patients had undergone revision surgery: three were included in the original study, and two additional revisions are included in the current study. Three revisions were for recurrent instability, one was for both humeral and baseplate loosening, and one was for resorption of a proximal humeral allograft that was placed as an allograft-prosthetic composite at the time of surgery. There were no mechanical baseplate failures.

Fig. 1

Kaplan-Meier survivorship analysis, with the end point being revision for any reason. Mean survival: 74.8 months (95% CI, 72.0 to 77.6); percentage survival at sixty months: 94%. (The time to revision [x axis] is measured in months, and Cum Survival = cumulative survival.)

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Table I summarizes the comparison of preoperative with postoperative outcome scores at the time of final follow-up. The patients have maintained their gains in total average ASES scores with an improvement from a preoperative score of 32 to a postoperative score of 75 at the time of the last follow-up (p < 0.001). Similar gains have been maintained with respect to average SST scores, with an improvement from a preoperative score of 2 to a postoperative score of 7 at the time of the last follow-up (p < 0.001). Patient outcome scores were also stratified by preoperative diagnosis, and this data is presented in Table I. With respect to shoulder motion, average forward flexion improved from 64° preoperatively to 144° (p < 0.001); average abduction, from 61° to 128° (p < 0.001); and average external rotation, from 15° to 51° (p < 0.001) at the time of the last follow-up.

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TABLE I Preoperative and Postoperative Outcomes for All Seventy-six Shoulders and Three Subgroups*

	Preoperative	Two-Year Follow-up†	Latest Follow-up Evaluation†	P Value‡
Total ASES score
All patients	32 (0-65)	78 (19-100)	75 (7-100)	0.189
Primary cuff deficiency	31 (0-60)	86 (50-100)	77 (17-100)	0.097
Previous rotator cuff surgery	36 (0-65)	78 (26-100)	77 (7-100)	0.780
Failed arthroplasty	30 (0-63)	67 (20-97)	71 (37-97)	0.804
ASES pain score
All patients	17 (0-43)	41 (8-50)	42 (0-50)	0.917
Primary cuff deficiency	16 (0-40)	45 (15-50)	41 (5-50)	0.345
Previous rotator cuff surgery	19 (0-43)	41 (10-50)	42 (0-50)	1.887
Failed arthroplasty	19 (0-43)	37 (13-50)	43 (15-50)	0.243
Simple shoulder test score
All patients	2 (0-7)	7 (0-12)	7 (0-12)	0.093
Primary cuff deficiency	2 (0-7)	8 (2-12)	8 (2-12)	0.335
Previous rotator cuff surgery	1 (0-5)	7 (0-12)	7 (1-12)	0.266
Failed arthroplasty	2 (0-7)	5 (1-12)	6 (0-12)	0.450
Forward flexion (deg)
All patients	64 (4-152)	118 (5-180)	144 (30-180)	<0.001
Primary cuff deficiency	70 (15-152)	130 (48-180)	150 (60-180)	<0.001
Previous rotator cuff surgery	66 (10-140)	125 (39-180)	146 (50-180)	0.005
Failed arthroplasty	51 (4-116)	90 (5-167)	123 (30-180)	<0.001
Abduction (deg)
All patients	61 (10-159)	110 (15-180)	128 (30-180)	<0.001
Primary cuff deficiency	66 (19-159)	123 (39-180)	136 (50-180)	0.008
Previous rotator cuff surgery	67 (21-158)	113 (51-180)	135 (50-180)	0.003
Failed arthroplasty	46 (10-72)	85 (16-149)	98 (30-180)	0.530
External rotation
All patients	15 (−40-78)	28 (−26-85)	51 (−60-100)	<0.001
Primary cuff deficiency	20 (−40-78)	35 (−10-85; p = 0.002)	45 (−60-90; p = 0.008)	0.048
Previous rotator cuff surgery	12 (−30-52)	28 (0-60)	58 (20-100)	0.003
Failed arthroplasty	10 (−23-48)	17 (−26-54; p = 0.40)	45 (−60-90)	0.069

*Data are expressed as the mean plus the range in parentheses.
†All preoperative to postoperative p values < 0.001 unless indicated.
‡Comparison of two-year follow-up and latest follow-up.

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TABLE I Preoperative and Postoperative Outcomes for All Seventy-six Shoulders and Three Subgroups*

	Preoperative	Two-Year Follow-up†	Latest Follow-up Evaluation†	P Value‡
Total ASES score
All patients	32 (0-65)	78 (19-100)	75 (7-100)	0.189
Primary cuff deficiency	31 (0-60)	86 (50-100)	77 (17-100)	0.097
Previous rotator cuff surgery	36 (0-65)	78 (26-100)	77 (7-100)	0.780
Failed arthroplasty	30 (0-63)	67 (20-97)	71 (37-97)	0.804
ASES pain score
All patients	17 (0-43)	41 (8-50)	42 (0-50)	0.917
Primary cuff deficiency	16 (0-40)	45 (15-50)	41 (5-50)	0.345
Previous rotator cuff surgery	19 (0-43)	41 (10-50)	42 (0-50)	1.887
Failed arthroplasty	19 (0-43)	37 (13-50)	43 (15-50)	0.243
Simple shoulder test score
All patients	2 (0-7)	7 (0-12)	7 (0-12)	0.093
Primary cuff deficiency	2 (0-7)	8 (2-12)	8 (2-12)	0.335
Previous rotator cuff surgery	1 (0-5)	7 (0-12)	7 (1-12)	0.266
Failed arthroplasty	2 (0-7)	5 (1-12)	6 (0-12)	0.450
Forward flexion (deg)
All patients	64 (4-152)	118 (5-180)	144 (30-180)	<0.001
Primary cuff deficiency	70 (15-152)	130 (48-180)	150 (60-180)	<0.001
Previous rotator cuff surgery	66 (10-140)	125 (39-180)	146 (50-180)	0.005
Failed arthroplasty	51 (4-116)	90 (5-167)	123 (30-180)	<0.001
Abduction (deg)
All patients	61 (10-159)	110 (15-180)	128 (30-180)	<0.001
Primary cuff deficiency	66 (19-159)	123 (39-180)	136 (50-180)	0.008
Previous rotator cuff surgery	67 (21-158)	113 (51-180)	135 (50-180)	0.003
Failed arthroplasty	46 (10-72)	85 (16-149)	98 (30-180)	0.530
External rotation
All patients	15 (−40-78)	28 (−26-85)	51 (−60-100)	<0.001
Primary cuff deficiency	20 (−40-78)	35 (−10-85; p = 0.002)	45 (−60-90; p = 0.008)	0.048
Previous rotator cuff surgery	12 (−30-52)	28 (0-60)	58 (20-100)	0.003
Failed arthroplasty	10 (−23-48)	17 (−26-54; p = 0.40)	45 (−60-90)	0.069

*Data are expressed as the mean plus the range in parentheses.
†All preoperative to postoperative p values < 0.001 unless indicated.
‡Comparison of two-year follow-up and latest follow-up.

Radiographic analysis revealed no evidence of lucency around the baseplate or baseplate screws in any patients. Two patients (3%) demonstrated asymptomatic humeral radiolucencies in three zones or more. Seven patients (9%) had radiographic evidence of scapular notching at the time of the last follow-up. All seven of these patients had minimal grade-1 notching according to the criteria of Sirveaux et al.⁶. This represents a change from the results reported in the original study, in which no patients had asymptomatic humeral loosening and no scapular notching was evident.

In our previous report, two patients sustained a traumatic dislocation (one shoulder was revised) and one patient experienced a nontraumatic dislocation that was also revised following failed attempts at closed reduction. Since our previous report, one shoulder dislocated due to a fall and the patient underwent revision surgery. Patients with recurrent instability were treated with open reduction and exchange of implants. Two of these patients underwent revision with a larger glenosphere component, as described in our previous report. The third patient with instability was treated with an implant exchange, but the component sizes were kept the same. The patient with the humeral loosening underwent revision to a long-stemmed humeral component, and the patient with the resorbed allograft was treated with removal of the bone graft and an increase in the glenosphere size due to the concern of instability. There were no other additional complications. Table II summarizes the complications requiring revisions at the two time periods.

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TABLE II Complications Requiring Revision Surgery

	Two-Year Follow-up	Since Two-Year Follow-up	Survivorship
Baseplate failure	0	0	100%
Recurrent instability	2	1	96.2% (75/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	1	0
Failed arthroplasty	1	1
Humeral loosening	1	0	98.7% (77/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	0	0
Failed arthroplasty	1	0
Resorption of proximal humeral allograft	0	1	98.7% (77/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	0	0
Failed arthroplasty	0	1

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TABLE II Complications Requiring Revision Surgery

	Two-Year Follow-up	Since Two-Year Follow-up	Survivorship
Baseplate failure	0	0	100%
Recurrent instability	2	1	96.2% (75/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	1	0
Failed arthroplasty	1	1
Humeral loosening	1	0	98.7% (77/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	0	0
Failed arthroplasty	1	0
Resorption of proximal humeral allograft	0	1	98.7% (77/78)
Primary cuff deficiency	0	0
Previous rotator cuff surgery	0	0
Failed arthroplasty	0	1

Conclusions

Background | Methods | Results | Conclusions

Patients who underwent RSA in our study have maintained their improved function with durable clinical and radiographic results at a minimum follow-up of five years. In our previous report, we noted that the addition of 5.0-mm peripheral locking screws for baseplate fixation had eliminated early baseplate failures that had been seen in an earlier series of patients in which a glenosphere with a center of rotation lateral to the glenoid had been utilized^1,2. We noted that the locking screws provided improved early fixation and allowed for osseous ingrowth into the baseplate to achieve good long-term fixation^1,7. There have been no baseplate failures or glenoid-sided screw-loosening to date in any patients in this series.

In our previous study, we reported no radiographic evidence of scapular notching at the minimum two-year follow-up point. We postulated that the use of a glenosphere with a center of rotation lateral to the glenoid moved the humeral socket away from the scapula and diminished notching in comparison with the more medialized Grammont design that was used in another published series, in which notching rates were as high as 96%⁸. Interestingly, at a minimum of five years of follow-up, our notching rate has had an increase from 0% to 9% in this study. All patients who did have notching had minimal grade-1 notches seen on their radiographs, and no notching approached the inferior baseplate screw in any of the patients. This indicates that scapular notching may be an evolving process that should be followed radiographically over time.

Lastly, we saw an increase in shoulder motion from the previous report; however, this may have been due to the different method of assessment. Sirveaux et al.⁶ and Guery et al.⁹, in longer-term studies in which the Grammont-style RSA was used, demonstrated a functional deterioration and increase in pain levels in some patients after the six-year follow-up point. Although we have yet to see any decrease in functional results or increase in pain levels, given these previous reports, we intend to continue to closely follow this cohort of patients to monitor their functional results and pain levels during the six to ten-year follow-up point.

Cuff D; Pupello D; Virani N; Levy J; Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90( 6):1244-51.[CrossRef][PubMed]

Frankle M; Siegal S; Pupello D; Saleem A; Mighell M; Vasey M. The Reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005 Aug;87( 8):1697-705.[CrossRef][PubMed]

Frankle M; Levy JC; Pupello D; Siegal S; Saleem A; Mighell M; Vasey M. The Reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. Surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178–90.[CrossRef][PubMed]

Levy J; Frankle M; Mighell M; Pupello D. The use of the Reverse Shoulder Prosthesis for the treatment of failed hemiarthroplasty for proximal humeral fracture. J Bone Joint Surg Am. 2007 Feb;89( 2):292-300.[CrossRef][PubMed]

Sperling JW; Cofield RH; O’Driscoll SW; Torchia ME; Rowland CM. Radiographic assessment of ingrowth total shoulder arthroplasty. J Shoulder Elbow Surg. 2000 Nov-Dec;9( 6):507-13.[CrossRef][PubMed]

Sirveaux F; Favard L; Oudet D; Huquet D; Walch G; Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004 Apr;86( 3):388-95.[CrossRef][PubMed]

Harman M; Frankle M; Vasey M; Banks S. Initial glenoid component fixation in “reverse” total shoulder arthroplasty: a biomechanical evaluation. J Shoulder Elbow Surg. 2005 Jan-Feb;14( 1 Suppl S):162S-167S.[CrossRef][PubMed]

Werner CM; Steinmann PA; Gilbart M; Gerber C. Treatment of painful pseudoparesis due to irreparable rotator cuff dysfunction with the Delta III reverse-ball-and-socket total shoulder prosthesis. J Bone Joint Surg Am. 2005 Jul;87( 7):1476-86.[CrossRef][PubMed]

Guery J; Favard L; Sirveaux F; Oudet D; Mole D; Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006 Aug;88( 8):1742-7.[CrossRef][PubMed]

Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Topics

rotator cuff ; reverse shoulder arthroplasty

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Derek Cuff, Rachel Clark, Derek Pupello, Mark Frankle; Reverse Shoulder Arthroplasty for the Treatment of Rotator Cuff DeficiencyA Concise Follow-up, at a Minimum of Five Years, of a Previous Report*. The Journal of Bone & Joint Surgery. 2012 Nov;94(21):1996-2000.

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