pADM patch augmentation for rotator cuff repair: In vivo safety and efficacy in a canine model
TL;DR
The pADM patch exhibits favorable biosafety and biocompatibility, promotes tendon structure recovery and tendon-bone healing, and enhances biomechanical strength, with promising potential for clinical translation.
Abstract
Objective Rotator cuff repair remains challenged by a high postoperative retear rate, particularly in moderate-to-large tears and in patients with poor tendon quality, where conventional suture-anchor fixation often fails to provide sufficient mechanical support during the healing process. This study aimed to systematically evaluate the in vivo safety, degradation characteristics, and reparative efficacy of a porcine-derived acellular dermal matrix (pADM) patch for rotator cuff augmentation in a large animal model. Methods Bilateral infraspinatus tendon insertion injury models were established in 24 adult beagle dogs. Animals in the test group received pADM patch augmentation in combination with suture-anchor fixation, whereas those in the control group underwent conventional anchor repair alone. Comprehensive assessments including hematological analysis, gross observation, CT/MRI images, histopathology (HE and Masson staining), and biomechanical testing were performed at 2, 4, 6, and 13 weeks postoperatively. Results Implantation of the pADM patch elicited no abnormal inflammatory or immune responses, indicating favorable biocompatibility. Imaging and histology analyses demonstrated superior tendon structural restoration and enhanced tendon-bone integration in the test group. The patch underwent progressive degradation and achieved effective host-tissue integration. Biomechanical testing revealed significantly higher maximum failure loads in the test group at all time points, indicating superior mechanical integrity of the repaired tendon (P < 0.05). Conclusion The pADM patch exhibits favorable biosafety and biocompatibility, promotes tendon structure recovery and tendon-bone healing, and enhances biomechanical strength. Its degradation kinetics match the host tissue remodeling process, with complete resorption by 13 weeks. This acellular dermal matrix patch represents a safe and effective augmentation material for rotator cuff repair, with promising potential for clinical translation.