Purpose
To define clinically significant outcomes (CSO) thresholds for minimal clinically
important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable
symptomatic state (PASS) in patients undergoing superior capsular reconstruction (SCR)
with an acellular dermal allograft. We also evaluated patient-specific variables predictive
of achieving CSO thresholds.
Methods
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES),
Single Assessment Numeric Evaluation (SANE), and subjective Constant-Murley (Constant)
scores were collected preoperatively and at the most recent follow up for patients
undergoing SCR from 2010 to 2019. A distribution-based approach was used to calculate
MCID, and an anchor-based approach was used to calculate SCB and PASS. Logistic regression
was used to determine factors associated with CSO achievement.
Results
Fifty-eight patients were identified (n = 39 males; n = 19 females) with a mean age of 53.4 ± 14.1 years at surgery and an average follow-up
of 23 months. The MCID, SCB, and PASS were 11.2, 18.02, and 68.82 for ASES, 14.5,
23.13, and 69.9 for SANE, and 3.6, 10, and 18 for Constant, respectively. Subscapularis
tear, female sex, and workers compensation (WC) status reduced odds of achieving MCID.
Reduced odds of achieving Constant SCB were associated with older age, female sex,
and WC status, while concomitant distal clavicle excision during SCR and lower preoperative
ASES increased odds of achieving ASES SCB. Reduced odds for achieving ASES PASS were
associated with female sex and WC status, while reduced odds for achieving SANE PASS
were associated with subscapularis tearing preoperatively.
Conclusion
On the basis of calculated values for MCID, SCB, and PASS, subscapularis tearing,
WC status, age, and sex are associated with failure to achieve clinically significant
outcomes following SCR. Concomitant distal clavicle excision during SCR and lower
preoperative ASES was predictive for achievement of MCID and SCB. By defining the
thresholds and variables predictive of achieving CSOs following SCR, surgeons may
better counsel patients prior to SCR.
Level of Evidence
Level IV, case series.
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Article info
Publication history
Published online: December 01, 2021
Accepted:
November 20,
2021
Received:
June 21,
2021
See commentary on page 1454Footnotes
The authors report the following potential conflicts of interest or sources of funding: There are no conflicts of interest to declare that are specific to this study. The authors did not receive any outside funding or grants in support of their research or preparation of this work. Neither they nor any member of their immediate families received payments or other benefits, or a commitment or agreement to provide such benefits from a commercial entity related to this work. B.J.C. reports research support from Aesculap, National Institutes of Health, Arthrex, and Regentis; other financial or material support from Aesculap, Operative Techniques in Sports Medicine, Smith & Nephew, Arthrex, Encore Medical, LP, GE Healthcare, Merck Sharp & Dohme Corporation, and SportsTek Medical, Inc., and Vericel Corporation. He reports being a paid consultant Aesculap, Regentis, Arthrex, Acumed LLC, and Vericel Corporation, all outside the submitted work. G.E.G. reports other financial or material support from Arthrex, Inc. A.R. reports other financial or material support, is a paid presenter or speaker, is a paid consultant, and receives research support from Arthrex. N.V. reports personal fees from Relievant Medsystems, Inc.; royalty or license from Smith & Nephew, Inc., and consulting fees from Stryker Corporation. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
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