Implant Plane Does Not Seem to Impact Shoulder Function after Direct-to-Implant Breast Reconstruction in Non-Radiated Patients: A Randomized Controlled Trial

Abstract

Background

Subpectoral implant placement in breast reconstruction has been associated with potential shoulder function impairment compared to prepectoral placement, though the evidence remains inconclusive. This study aimed to investigate differences in shoulder function following mastectomy and direct-to-implant breast reconstruction using prepectoral or subpectoral implant placement.

Methods

Forty-two women aged 18 years or older, eligible for direct-to-implant breast reconstruction, were randomized 1:1 to undergo either prepectoral or subpectoral implant placement. Data were collected at baseline and at 3- and 12-month follow-ups. Shoulder function was assessed using the validated Constant Shoulder Score (CSS), which evaluates pain, activities of daily living, range of motion, and strength. Pectoralis major muscle (PMM) strength was also measured.

Results

Baseline and demographic characteristics were comparable between the groups. No differences were observed in total CSS or the modified CSS (including the PMM strength) between the prepectoral and subpectoral groups at baseline or at the 3- and 12-month follow-ups. At 12 months, total CSS (p = 0.74) and modified CSS (p = 0.45) remained similar across both groups.

Conclusion

There were no significant differences in shoulder and arm function between the sub- and prepectoral reconstruction groups. These findings suggest that concerns regarding shoulder function should not dictate the choice of implant placement plane in direct-to-implant breast reconstruction.

Keywords

impaired shoulder function - functional assessment - subpectoral implant placement - prepectoral implant placement - direct-to-implant reconstruction

Authors' Contributions

All authors have substantially contributed to

(1) conception and design, acquisition of data, and analysis and interpretation of data,

(2) drafting the article and revising it critically,

(3) final approval of the published version,

(4) ensuring that questions related to the accuracy or integrity of any part of the work has appropriately been investigated and resolved.

Ethical Approval

The study was approved by the Danish Committee on Health Research Ethics for Southern Denmark outside Europe; this approval is often referred to as the institutional review board number (S-20160160) and the Danish Data Protection Agency (17/13640), and reported according to the principles of the Declaration of Helsinki.

Patient Consent

The patients provided written informed consent for the publication and the use of their images.

Publikationsverlauf

Eingereicht: 29. August 2023

Angenommen: 15. Juni 2025

Artikel online veröffentlicht:
18. September 2025

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