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Interpositional scaffold anchor rotator cuff footprint tear repair: excellent survival, healing, and early outcomes

  • SHOULDER
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

Shoulder function limitation duration after a full-thickness rotator cuff tendon (RCT) tear may influence post-repair healing and outcomes. A suture anchor was developed to improve footprint repair fixation and healing through biological fluid delivery and scaffold augmentation. The primary multicenter study objective was to evaluate RCT repair failure rate based on 6-month MRI examination, and device survival at 1-year follow-up. The secondary objective was to compare the clinical outcomes of subjects with shorter- and longer-term shoulder function limitation duration.

Methods

Seventy-one subjects (46 men) with moderate-to-large RCT tears (1.5–4 cm), at a median 61 years of age (range = 40–76), participated in this study. Pre-repair RCT tear location/size and 6-month healing status were confirmed by an independent radiologist. Subjects with shorter- (Group 1: 17.8 ± 21 days, n = 37) and longer-term (Group 2: 185.4 ± 89 days, n = 34) shoulder function limitation durations were also compared over 1 year for active mobility, strength, American Shoulder and Elbow Surgeon’s Shoulder Score (ASES score), Veterans RAND 12 Item Health Survey (VR-12), and visual analog scale (VAS) pain and instability scores.

Results

Three of the 52 subjects [5.8%] who underwent 6-month MRI experienced a re-tear at the original RCT footprint repair site. By the 1-year follow-up, overall anchor survival was 97%. Although Group 2 displayed lower ASES and VR-12 scores pre-repair (ASES = 40.1 ± 17 vs. 47.9 ± 17; VR-12 physical health (PH) = 37.2 ± 9 vs. 41.4 ± 8) (p ≤ 0.048), at 3-month post-RCT repair (ASES = 61.3 ± 19 vs. 71.3 ± 20; VR-12 PH = 40.8 ± 8 vs. 46.8 ± 9) (p ≤ 0.038), and at 6-month post-RCT repair (ASES = 77.4 ± 18 vs. 87.8 ± 13; VR-12 PH = 48.9 ± 11 vs. 54.0 ± 9) (p ≤ 0.045), by 1-year post-RCT repair, groups did not differ (n.s.). Between-groups VR-12 mental health score differences were not evident at any time period (n.s.). Shoulder pain and instability VAS scores also did not differ (n.s.), displaying comparable improvement between groups from pre-RCT repair to 1-year post-RCT repair. Groups had comparable active shoulder mobility and strength recovery at each follow-up (n.s.).

Conclusion

At 6-month post-RCT repair, only 3/52 of patients [5.8%] had a footprint re-tear, and at 1-year follow-up, overall anchor survival was 97%. Use of this scaffold anchor was associated with excellent early clinical outcomes regardless of shoulder function impairment duration.

Level of evidence

II.

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Data availability

The datasets generated during, and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.

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Acknowledgements

Thanks to Dr. Bryan Butler of the Orthopaedic Medical Group of Tampa Bay and Dr. Surena Namdari of the Rothman Institute for their subject enrollment assistance.

Funding

This study was funded by Cayenne Medical, Inc., a Zimmer Biomet company.

Author information

Authors and Affiliations

  1. Norton Orthopedic Institute, 9880 Angies Way Suite 250, Louisville, KY, 40241, USA

    Ryan Krupp & John Nyland

  2. Florida Orthopaedic Institute, Temple Terrace, USA

    Mark Frankle & Christopher E. Baker

  3. Department of Orthopaedic Surgery, University of Louisville, Louisville, USA

    John Nyland

  4. University of Virginia, Charlottesville, USA

    Brian C. Werner

  5. Desert Orthopedic Center, Rancho Mirage, USA

    Patrick St. Pierre

  6. University of Utah, Salt Lake City, USA

    Robert Tashjian

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  1. Ryan Krupp
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  5. Brian C. Werner
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Contributions

RK: Zimmer Biomet: research funding, consulting; Stryker: consulting, product development; Arthrex: consulting. MF: Enovis: consulting and royalties; Synchrony Health: consulting. JN: No disclosures. CEB: Zimmer Biomet: consulting. CEW: Arthrex: research funding; Pacira: research funding; Exatech: educational or research grant; Zimmer Biomet: educational or research grant. PP: Zimmer Biomet: consulting; Enovis: consulting and royalties; Stryker Mako: consulting. RT: Stryker: consulting; Zimmer Biomet: consulting; Shoulder Innovations: consulting; Genesis Innovations: consulting; DePuy Mitek: consulting.

Corresponding author

Correspondence to John Nyland.

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Conflicts of interest

Drs. Krupp, Frankle, Baker, Werner, St. Pierre and Tashjian received education grant, research funding, or consulting fees from Zimmer Biomet related to the current study. Dr. Nyland had no conflicts of interest to declare related to the current study.

Ethical approval

Institutional review board approval was sought and obtained for each study site through the Western Institutional Review Board, Puyallup, WA, USA.

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Krupp, R., Frankle, M., Nyland, J. et al. Interpositional scaffold anchor rotator cuff footprint tear repair: excellent survival, healing, and early outcomes. Knee Surg Sports Traumatol Arthrosc 31, 2670–2680 (2023). https://doi.org/10.1007/s00167-023-07383-2

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