{"title":"pADM patch augmentation for rotator cuff repair: <i>In vivo</i> safety and efficacy in a canine model.","authors":"Jianbo Li, Qingjun Kong, Qian Xu, Kuansong Wang","doi":"10.3389/fbioe.2026.1912857","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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 <i>in vivo</i> safety, degradation characteristics, and reparative efficacy of a porcine-derived acellular dermal matrix (pADM) patch for rotator cuff augmentation in a large animal model.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12444,"journal":{"name":"Frontiers in Bioengineering and Biotechnology","volume":"14 ","pages":"1912857"},"PeriodicalIF":5.8000,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13687306/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Bioengineering and Biotechnology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.3389/fbioe.2026.1912857","RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The translation of new discoveries in medicine to clinical routine has never been easy. During the second half of the last century, thanks to the progress in chemistry, biochemistry and pharmacology, we have seen the development and the application of a large number of drugs and devices aimed at the treatment of symptoms, blocking unwanted pathways and, in the case of infectious diseases, fighting the micro-organisms responsible. However, we are facing, today, a dramatic change in the therapeutic approach to pathologies and diseases. Indeed, the challenge of the present and the next decade is to fully restore the physiological status of the diseased organism and to completely regenerate tissue and organs when they are so seriously affected that treatments cannot be limited to the repression of symptoms or to the repair of damage. This is being made possible thanks to the major developments made in basic cell and molecular biology, including stem cell science, growth factor delivery, gene isolation and transfection, the advances in bioengineering and nanotechnology, including development of new biomaterials, biofabrication technologies and use of bioreactors, and the big improvements in diagnostic tools and imaging of cells, tissues and organs.
In today`s world, an enhancement of communication between multidisciplinary experts, together with the promotion of joint projects and close collaborations among scientists, engineers, industry people, regulatory agencies and physicians are absolute requirements for the success of any attempt to develop and clinically apply a new biological therapy or an innovative device involving the collective use of biomaterials, cells and/or bioactive molecules. “Frontiers in Bioengineering and Biotechnology” aspires to be a forum for all people involved in the process by bridging the gap too often existing between a discovery in the basic sciences and its clinical application.
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