Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up (original) (raw)
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Muscles, ligaments and tendons journal
partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears. Studies suggest the addition of new tendinous tissue to injured cuff tendons would significantly decrease peak strain, possibly protecting against tear progression. The aim of this study was to assess the ability of a highly-porous collagen implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial-thickness cuff tears. following arthroscopic subacromial decompression, the implant was attached to the bursal surface of the supraspinatus tendon in a prospective series of 13 consecutive patients with intermediate - (3-6 mm) to high-grade (>6 mm) partial - thickness cuff tears (5 articular, 3 bursal, 5 intra-substance). Tendon thickness, defect size, and tendon quality were evaluated using magnetic resonance imaging (MRI) preoperatively and at 3, 6, 12, and 24 months postoperatively. Clinical outcomes wer...
Restore Orthobiologic Implant: Not Recommended for Augmentation of Rotator Cuff Repairs
Journal of Bone and Joint Surgery-american Volume, 2007
Background: Following repairs of large-to-massive tears of the rotator cuff, the rates of tendon retears are high and often involve tissue deficiency. Animal studies of the Restore Orthobiologic Implant, a collagen-based material derived from the small intestine mucosa of pigs, have indicated that it might be used to help overcome such problems. We carried out a study to determine whether patients who received this xenograft to augment a rotator cuff repair exhibited greater shoulder strength, shoulder function, and/or resistance to retearing.
Journal of Shoulder and Elbow Surgery
Background: To evaluate the anatomic integrity of rotator cuff repair performed by medialized single row and augmented by a porcine dermal patch, in comparison with a nonaugmented group. Methods: We conducted a single-center, prospective, double-blinded, randomized controlled trial. The sample size was predefined, and patients were divided into a study group and a control group, assessed preoperatively and at 1, 3, 6, 12, and 24 months. The EuroQol-visual analog scale; Constant-Murley questionnaire; Disabilities of the Arm, Shoulder and Hand Score; and Simple Shoulder Test were administered. The humeral-acromial distance was calculated on radiographs. Tendon thickness, tear extension, and tendon signal intensity were all measured on magnetic resonance images (MRIs) along with an evaluation of footprint extension and a classification into one of 4 healing gradesdhealed, thinned, partially healed, not healed. Results: The study population consisted of 92 patients who were equally randomized into 2 homogenous groups. Sixty-nine patients completed the 24-month follow-up. The study group showed a healing rate of 97.6% compared with 59.5% for the standard repair group. The study group showed better results in terms of repaired tendon thickness and footprint coverage, with a P value < .05, although the tendon density was comparable. The study group showed better strength recovery and functionality with the outcome scores submitted. During the entire study, only 2 patients reported complications, calling for a biopsy during revision surgery. Conclusions: Rotator cuff repairs augmented with a porcine dermal patch resulted in excellent clinical outcomes with a higher healing rate and close-to-normal MRI findings. The technique is safe and effective; in addition, it is reproducible and allows for better outcomes compared with those of standard medialized single-row repairs. This study was approved by the Comitato Etico della Provincia di Verona (study no. 394 CEP).
Biological Augmentation in Repair and Reconstruction of the Rotator Cuff
Operative Techniques in Sports Medicine, 2015
Rotator cuff tears are among the most common causes of pain and disability in the upper extremity. Despite significant advances in repair techniques and instrumentation, re-tear rates after surgery remain high. Numerous avenues of structural and biological augmentation have been explored to increase healing potential and achieve successful outcomes particularly in patients with massive cuff tears and/or those undergoing revision surgery. The purpose of this paper is to present and discuss various techniques currently published that are designed to augment this process through variable methodologies. One common methodology is the use of graft tissue to "load share" with the repair and/or facilitate placement of pluripotential stem cell or growth factors at the site of needed healing. Although this field remains in development, this paper attempts to explain the concepts currently employed and summarize the current FDA approved options.
Augmentation of Rotator Cuff Repair With Soft Tissue Scaffolds
Orthopaedic Journal of Sports Medicine, 2015
Background Tears of the rotator cuff are one of the most common tendon disorders. Treatment often includes surgical repair, but the rate of failure to gain or maintain healing has been reported to be as high as 94%. This has been substantially attributed to the inadequate capacity of tendon to heal once damaged, particularly to bone at the enthesis. A number of strategies have been developed to improve tendon-bone healing, tendon-tendon healing, and tendon regeneration. Scaffolds have received considerable attention for replacement, reconstruction, or reinforcement of tendon defects but may not possess situation-specific or durable mechanical and biological characteristics. Purpose To provide an overview of the biology of tendon-bone healing and the current scaffolds used to augment rotator cuff repairs. Study Design Systematic review; Level of evidence, 4. Methods A preliminary literature search of MEDLINE and Embase databases was performed using the terms rotator cuff scaffolds, r...
Augmentation techniques for rotator cuff repair
British Medical Bulletin, 2013
Introduction: There is a high rate of recurrence of tear and failed healing after rotator cuff repair. Several strategies have proposed to augment rotator cuff repairs to improve postoperative outcome and shoulder performance. We systematically review the literature on clinical outcome following rotator cuff augmentation.
Biologic and pharmacologic augmentation of rotator cuff repairs
The Journal of the American Academy of Orthopaedic Surgeons, 2011
As rotator cuff repair techniques have improved, failure of the tendon to heal to the proximal humerus is less likely to occur from weak tendon-to-bone fixation. More likely causes of failure include biologic factors such as intrinsic tendon degeneration, fatty atrophy, fatty infiltration of muscle, and lack of vascularity of the tendons. High failure rates have led to the investigation of biologic augmentation to potentially enhance the healing response. Histologic studies have shown that restoration of the rotator cuff footprint during repair can help reestablish the enthesis. In animal models, growth factors and their delivery scaffolds as well as tissue engineering have shown promise in decreasing scar tissue while maintaining biomechanical strength. Platelet-rich plasma may be a safe adjuvant to rotator cuff repair, but it has not been shown to improve healing or function. Many of these strategies need to be further defined to permit understanding of, and to optimize, the biolo...
MUSCULOSKELETAL SURGERY, 2011
The high incidence of recurrent tendon tears after repair of massive cuff lesions is prompting the research of materials aimed at mechanically or biologically reinforcing the tendon. Among the materials studied upto now, the extracellular matrix (ECM) scaffolds of human origin have proved to be the safest and most efficient, but the current laws about grafts and transplants preclude their use in Europe. In order to overcome this condition in 2006, we started a project regarding the production of an ECM scaffold of human origin which could be implanted in Europe too. In 2009, the clinical study began with the implantation of dermal matrix scaffolds in 7 middle-aged patients affected with large/massive cuff lesions and tendon degeneration. Out of 5 cases, followed for at least 1 year in which the scaffold was employed as an augmentation device, there were 3 patients with complete healing, 1 partial re-tear, and 1 total recurrence. The absence of adverse inflammatory or septic complications allows to continue this line of research with a prospective controlled study in order to define the real advantages and correct indications offered by scaffold application.