Description of Patient Characteristics and Clinical and Economic Outcomes of Orthopedic Sutures Used for Rotator Cuff Repair

Abstract

Background A better understanding of real-world clinical and economic outcomes associated with orthopedic sutures used for rotator cuff repair is needed.

Research Design and Methods A retrospective, descriptive cohort study using Premier Healthcare Database hospital-based data evaluated patients treated with Dynacord™ or FiberWire® for rotator cuff repair between January 2017-February 2022. Baseline patient characteristics and twelve-month outcomes were assessed. Each suture cohort was analyzed separately. No comparative analyses were performed in this study.

Results Baseline demographics of 1 074 patients treated with Dynacord™ and 19 899 treated with FiberWire®, respectively, were mean age 59.4, 59.9 years; 59.4% and 58.5% male. All-cause twelve-month hospital revisits were observed in 31.4% and 42.4%, and the incidence proportion with shoulder-related hospital revisits was 12.6% and 14.0%, respectively. The incidence of twelve-month rotator cuff re-repair was 1.2% for Dynacord™ and 1.8% for FiberWire®. Dynacord™ twelve-month all-cause revisit costs (standard deviation [SD]) were $1 649 ($5 870) and $2 230 ($7 204) for FiberWire®. Twelve-month complications, device removals, and manipulations were ≤1% for both cohorts.

Conclusions This study contributes clinical and economic real-world evidence on two types of orthopedic sutures used for rotator cuff repair.

Competing Interest Statement

All authors were employees or contractors of Johnson & Johnson at time of the study. Authors K.Corso, C.Smith, B.Varughese, and J. Ruppenkamp are currently employees of Johnson & Johnson.

Funding Statement

The study was funded by Johnson and Johnson, Inc.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee/IRB of New England Institutional Review Board waived ethical approval for this work because the study does not involve human subjects research.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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