Effect of patient-reported allergies on reverse total shoulder arthroplasty outcomes at over two years follow-up

Andrew A. Palosaari; Christopher A. White; Benjamin D. Gross; Akshar Patel; Troy Li; Evan L. Flatow; Paul J. Cagle

doi:10.1016/j.jor.2024.01.018

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51 (); 87-90

doi:

10.1016/j.jor.2024.01.018

Effect of patient-reported allergies on reverse total shoulder arthroplasty outcomes at over two years follow-up

Andrew A. Palosaari^a, Christopher A. White^a, Benjamin D. Gross^a, Akshar Patel^a, Troy Li^a, Evan L. Flatow^a, Paul J. Cagle^a,

a Department of Orthopedic Surgery, Icahn School of Medicine at Mount Sinai, 425 West 59th Street, New York City, NY, USA

∗Corresponding author: Paul J. Cagle. Paul.Cagle@mountsinai.org

Received: 2023-7-2, Accepted: 2024-1-30, Published: 2024-2-1

Professor P K Surendran Memorial Education Foundation

Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Understanding the factors that lead to poor outcomes after reverse total shoulder arthroplasty (rTSA) is important to appropriate patient counseling. While patient-reported allergies (PRAs) have been shown to be associated with poorer outcomes after both TKA and THA, their effect on rTSA outcomes remains unclear. This study investigated the effect of zero, one, and two or more preoperative PRAs on clinical outcomes after rTSA at over two years follow-up in a cohort of fifty-two patients from our institution.

Patients who underwent rTSA and had a minimum follow-up time of two years were identified from an institutional database. Patients were split into cohorts of zero, one, and two or more PRAs. Range of motion (ROM) was assessed by degrees of forward elevation, external rotation, and internal rotation. Patient-reported outcomes (PROs) were assessed by the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeon (ASES) score, and Simple Shoulder Test (SST) score.

Fifty-two patients, 10 of whom reported one allergy and 11 of whom reported two or more allergies, were included in our analysis. Mean ROM and PROs improved after rTSA in each cohort. Differences in ROM and PROs between cohorts did not reach statistical significance; however, patients with PRAs tended to have worse preoperative forward elevation, VAS score, and ASES score. Two patients in the zero-allergy cohort required revision (6 %).

This study found no statistically significant difference in clinical outcomes among cohorts of patients with zero, one, or two or more preoperative PRAs after rTSA at over two years follow-up. However, patients with PRAs tended to have lower preoperative functional scores. We postulate that this may be the result of psychosomatic factors at play in these patients. PRAs should not dissuade patients or clinicians from pursuing rTSA.

Keywords

Reverse shoulder arthroplasty

Arthroplasty

Allergies

Patient-reported allergies

Patient-reported outcomes

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1 Introduction

Reverse total shoulder arthroplasty (rTSA) was revolutionized by Grammont in 1985 for treatment of patients with shoulder pseudoparalysis (i.e. limited active shoulder forward elevation due to a massive rotator cuff tear).¹ Reversing the native ball-and-socket anatomy of the shoulder joint and medializing the center of rotation of the humerus in the glenoid, the procedure allows for recruitment of additional deltoid muscle fibers to assist with arm forward elevation and abduction.² Given the increasing frequency that rTSA is being performed in the United States,³^,⁴ studies have been investigating the effect that risk factors, such as alcohol use,⁵ tobacco use,^6–8 pulmonary hypertension,⁹ diabetes,¹⁰^,¹¹ and body mass index (BMI)¹² have on outcomes. Recently, one such risk factor of interest is a patient's number of self-reported allergies. While patient-reported allergies (PRAs) have been shown to be associated with poorer outcomes after both TKA and THA.^13–15 their effect on rTSA, remains unclear with studies yielding contradictory results.^16–18 In this study, we examined the effect of zero, one, and two or more preoperative PRAs on clinical outcomes after rTSA at over two years follow-up in a cohort of 52 patients from our institution.

2 Materials and methods

2.1

2.1 Patient cohort

Patients were identified from an institutional database by the Current Procedural Code 23,472. Minimum follow-up time for inclusion was two years. A single board-certified surgeon who was fellowship trained in shoulder and elbow performed all the procedures. Demographic factors, including age at time of surgery, sex, body mass index (BMI), American Society of Anesthesiologist (ASA) score (as a surrogate for comorbidities), and interval to final follow-up, were recorded but not controlled for. Patient activity level before surgery was not recorded. Patients with a follow-up time of less than two years or who had undergone non-arthroplasty shoulder procedures were excluded. All patients underwent a standard post-operative physical therapy. This study was approved by the institutional review board.

2.2

2.2 Clinical measurements

Range of motion (ROM) was assessed by degrees of forward elevation, external rotation, and internal rotation. Internal rotation was assessed numerically by the highest vertebral level that could be reached according to the scale described by Amroodi et al.¹⁹ Patient-reported outcomes (PROs) were assessed by the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeon (ASES) score, and Simple Shoulder Test (SST) score.

2.3

2.3 Surgical technique

The proximal humerus was approached through the deltopectoral interval. The subscapularis was addressed with either a peel or osteotomy. The humeral head and glenoid were prepared with standard reaming. The humeral stem implant was fixed via cementation, and baseplate was fixed on the glenoid with a tantalum central peg and a minimum of two screws. A Zimmer Trabecular Metal Reverse Shoulder Implant from Zimmer Incorporated (Warsaw, In.) was used in all cases. The subscapularis was repaired through bone tunnels, and a latissimus dorsi transfer was performed when indicated.

2.4

2.4 Statistics

Inferential statistics were used to determine the relationship between PRAs and clinical outcomes. Fisher's Exact and analysis of variance (ANOVA) tests were used to identify statistically significant differences in the demographics between our cohorts of zero, one, and two or more PRAs. Mean ± standard deviation was calculated for all outcome measures. ANOVA tests were used to compare preoperative, postoperative, and pre-to-postoperative differences between our cohorts. Results with p-values <0.05 were considered statistically significant.

3 Results

Fifty-two patients who underwent rTSA were included in analysis. Thirty-one of these patients reported no allergies, 10 reported one allergy, and 11 reported two or more allergies. In total, 17 patients were male and 35 were female. Mean age at time of surgery was 70 years and mean time to follow-up was 7.5 years. Mean BMI was 28 and mean ASA score was 2.3. No statistically significant difference was found in demographic factors among cohorts of zero, one, and two or more PRAs. See Table 1 for patient demographics broken down by cohort.

Table 1 Patient demographics.

rTSA	No allergies	1 Allergy	2+ Allergy	p-value	Test Used
N Total	31	10	11
N Male	13	2	2	0.29	Fisher's
% Male	42 %	20 %	18 %
N Female	18	8	9
% Female	58 %	80 %	82 %
Mean Age at Surgery	68.75	72.91	71.81	0.56	ANOVA
SD Age at Surgery	14.77	3.16	5.74
Mean Time since Surgery	7.86	7.36	6.42	0.55	ANOVA
SD Time since Surgery	3.94	3.55	3.25
BMI	28.70	28.12	27.07	0.76	ANOVA
SD BMI	5.79	5.37	7.63
ASA Scores	2.30	2.38	2.40	0.87	ANOVA
SD ASA	0.54	0.74	0.52

Mean ROM and PROs improved after rTSA among all cohorts (see Table 2). Mean preoperative forward elevation of 86°, 85°, and 67° (p = 0.45) among cohorts of zero, one, and two or more PRAs improved postoperatively to 129°, 138°, and 131° (p = 0.56), respectively (see Table 2). Mean external rotation of 24°, 26°, and 25° (p = 0.97) improved to 31°, 40° and 35° (p = 0.51), respectively. Mean internal rotation numerical values of 7, 11, and 8 (p = 0.15) improved to 10, 12, and 11 (p = 0.56), respectively. Mean VAS scores of 6, 6, and 6 (p = 0.86) improved to 1, 3, and 2 (p = 0.05), respectively. Mean ASES scores of 35, 33, and 27 (p = 0.42) improved to 74, 66, and 67 (p = 0.48), respectively. Mean SST scores of 2, 3, and 1 (p = 0.23) improved to 7, 6, and 6 (p = 0.78), respectively. Differences between the cohorts of zero, one, and two or more PRAs did not meet statistical significance in any outcome measure; however, we identified that patients with PRAs tended to have worse preoperative forward elevation, VAS score, and ASES score.

Table 2 ROM & PRO Pre- and postoperative outcomes.

		No allergies	1 Allergy	2+ Allergies	p-value	Test Used
FE	Preop	86.21	85.00	67.27	0.49	ANOVA
	SD	42.69	58.36	38.95
	Postop	129.50	138.00	131.36	0.56	ANOVA
	SD	25.24	13.17	15.51
ER	Preop	23.57	26.00	25.00	0.97	ANOVA
	SD	31.82	30.62	26.74
	Postop	31.33	39.50	35.00	0.51	ANOVA
	SD	21.45	9.56	20.37
IR	Preop	7.30	11.29	7.67	0.15	ANOVA
	SD	4.34	5.12	5.05
	Postop	9.68	11.71	10.71	0.56	ANOVA
	SD	4.27	4.96	4.75
VAS	Preop	5.78	6.00	6.36	0.86	ANOVA
	SD	2.86	2.74	2.98
	Postop	1.11	3.33	1.56	0.05	ANOVA
	SD	1.71	2.96	2.96
ASES	Preop	35.02	32.23	26.52	0.42	ANOVA
	SD	15.32	19.38	19.04
	Postop	73.80	66.06	66.85	0.48	ANOVA
	SD	19.42	23.30	18.42
SST	Preop	2.30	2.78	1.00	0.23	ANOVA
	SD	2.90	1.99	0.67
	Postop	6.70	6.22	6.11	0.87	ANOVA
	SD	3.29	3.87	2.76

Regarding pre-to-post operative changes (see Table 3), mean forward elevation improved by 43°, 66°, and 64° among the cohorts of zero, one, and two or more PRAs (p = 0.23), respectively. Mean external rotation improved by 9°, 12°, 10°, respectively (p = 0.98). Mean internal rotation numerical values improved by 3, improved by 1, and worsened by 2, respectively (p = 0.28). Mean VAS score decreased by 5, 3, and 5 points, respectively (p = 0.19). Mean ASES score increased by 35, 32, and 28 points, respectively (p = 0.80). Mean SST score increased by 4, 3, and 5 points, respectively (p = 0.64). Differences between the cohorts of zero, one, and two or more PRAs did not meet statistical significance in any pre-to-postoperative change; however, we identified that patients with PRAs tended to have greater improvements in forward elevation and external rotation, and less improvement in internal rotation and ASES score.

Table 3 Pre-to-postoperative changes.

	No allergies	1 Allergy	2+ Allergies	p-value	Test Used
FE	43.28	66.25	64.09	0.23	ANOVA
ER	9.29	11.88	10.00	0.98	ANOVA
IR	2.70	0.83	−1.88	0.28	ANOVA
VAS	−4.61	−2.57	−5.44	0.19	ANOVA
ASES	35.48	32.30	28.18	0.80	ANOVA
SST	4.14	3.14	5.11	0.64	ANOVA

Two patients in the zero-allergy cohort required revision (6 %), while no patient in the one or two or more allergy cohorts required revision (see Table 4).

Table 4 Revision rate.

	No allergies	1 Allergy	2+ Allergies	p-value	Test Used
Revisions (n)	2	0	0	1.00	Fisher's
% Revision	6 %	0 %	0 %

4 Discussion

Shoulder arthroplasty has been the subject of many studies investigating the risk factors that might lead to poorer outcomes.^5–12 The present study investigated the effect of PRAs on rTSA outcomes over two years after their index procedure. The main finding of this study was that PRAs did not influence clinical outcomes at over two years follow up.

Inconsistent results from recent studies highlight the importance of further investigation into the effect that a patient self-reported allergies may have on long-term rTSA outcomes. Forlizzi et al. investigated predictors of poor clinical outcomes in 338 patients who underwent rTSA with a minimum of two years follow-up and found that a higher number of PRAs were associated with poorer outcomes defined as an ASES score in the bottom quartile of their cohort.¹⁶ Elrick et al. investigated the effect of patient-reported drug and latex allergies on 367 patients who underwent rTSA with a minimum follow-up of one year and found more PRAs to be associated with poorer QuickDASH score.¹⁷ All other outcome measures they investigated including ASES score, Single Assessment Numerical Evaluation score, 12-Item Short Form Health Survey scores showed a trend of more PRAs leading to worse outcomes but did not reach statistical significance. However, in contrast, a study by Rosenthal et al. examined 98 patients who underwent rTSA with 180 days follow-up and found no difference in any of outcome measures of SST score, VAS score, and forward elevation.¹⁸ Another study by Kennon et al. of 43 patients with self-reported metal allergies undergoing rTSA found that patients had satisfactory clinical outcomes at a mean follow-up time of 5.4 years and a revision rate of only 3.8 %.²⁰

The present study had an average follow-up of 7.5 years and found no statistically significant difference in ROM and PROs between the cohorts of patients undergoing rTSA with zero, one, and two or more PRAs. Demographic factors, including ASA score as a surrogate for comorbidities, were not statistically significant between cohort groups. Nevertheless, some trends in the data were seen. Patients with one or more PRAs tended to have worse preoperative values of forward elevation, VAS score, and ASES score. They also tended to have greater improvement in forward elevation and external rotation and less improvement in internal rotation and ASES score. The difference in revision rates between the cohorts was not statistically significant.

While the mechanism by which PRAs may lead to poorer clinical outcomes was not investigated in this study (nor did we find it to lead to poorer outcomes), other studies have shed light on possible explanations. Ko et al. investigated the effect of metal allergies on shoulder arthroplasty and suggested that the poorer outcomes were a result of implant failure due to an allergic reaction to the implant.²¹ Some researchers have suggested the poorer outcomes are due to suboptimal pre-incisional antibiotic prophylaxis. Others postulate that PRAs are a marker of psychiatric comorbidities which already predispose patients to poorer clinical outcomes.^5–7^,²² Pyschiatric comorbidity has been shown to be associated with poorer outcomes after both knee²³ and shoulder arthroplasty.²⁴^,²⁵ Rauck et al. showed that worse SF-12 mental component summary scores were associated with less patient satisfaction at two years (P = 0.034) in a cohort of 161 patients who underwent rTSA. Werner et al. found that preoperative depression was a predictor of significantly less improvement in and lower final ASES score (p < 0.001, p < 0.001, respectively) in a matched cohort of 88 patients who had preoperative depression compared to 88 patients without preoperative depression, all undergoing total shoulder arthroplasty. Further, psychiatric diagnoses have been shown to be associated with a high number of PRAs. For example, Ferrer et al. found that a diagnosis of anxiety was associated with a higher number of PRAs (p = 0.039) in a cohort of 209 patients undergoing total knee arthroplasty. Thus, since a higher number of PRAs and psychiatric comorbidity are connected, psychiatric comorbidity may have been the reason that we observed the trends in our data.

Limitations of this study include its small sample size and retrospective design. Given the trends appreciated, it is possible with a larger sample that a significant difference could have been appreciated. Further, while demographic factors, including ASA score, were not statistically significant between groups, comorbidities, which were not recorded, could have confounded results. Additionally, PRAs identified in this study were extracted from electronic health medical records which are prone to input errors. Also, our clinical data was incomplete since some patients lacked certain outcome measures, and in these instances, we included in our analysis the outcome measures we had available. The major strength of the study is a long follow-up time, a mean over seven years. Future studies should aim to have similar long-term follow-up, but include a larger cohort of patients, control for co-morbidities, blind physicians to a patient's number of PRAs when collecting outcome measures, and collected data prospectively.

5 Conclusion

In conclusion, this study showed that patients with a higher number of PRAs sustain similar improvement in clinical outcomes after rTSA over the longer-term to patients who report no PRAs. However, patients with PRAs may have lower preoperative functional scores and greater pre-to-postoperative changes. This may be because a higher number of PRAs is linked to psychiatric comorbidity, which already predispose patients to poorer outcomes. Regardless, a higher number of PRAs should not dissuade patients or clinicians from pursuing rTSA as outcomes are good at over two years follow-up. Larger long-term studies controlling for co-morbidities are needed to clarify the association of PRAs with potentially poorer outcomes after rTSA. Understanding of this association will help orthopedic surgeons more appropriately counsel and risk-stratify patients.

Funding/sponsorship

None.

Ethical statement

All procedures were performed in compliance with relevant laws and institutional guidelines and have been approved by the appropriate institutional committee(s).

Guardian/patient consent

N/a.

CRediT authorship contribution statement

Andrew A. Palosaari: Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing. Christopher A. White: Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing. Benjamin D. Gross: Data curation, Formal analysis, Project administration, Writing – review & editing. Akshar Patel: Data curation, Writing – review & editing. Troy Li: Data curation, Writing – review & editing. Evan L. Flatow: Conceptualization, Data curation, Supervision, Validation, Writing – review & editing. Paul J. Cagle: Conceptualization, Data curation, Supervision, Validation, Project administration, Resources, Writing – review & editing.

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