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.
Background: There is no agreement on the best treatment for displaced midshaft clavicle fractures (MCFs), which are currently addressed by nonoperative or surgical approaches. Purpose: To compare fracture healing and functional outcome after surgical versus nonsurgical treatment of MCFs, to help specialists in deciding between these different strategies by providing a synthesis of the best literature evidence. Study Design: Meta-analysis. Methods: A systematic research of the literature was performed in different online databases: PubMed, Web of Science, Cochrane library, and grey literature. PRISMA (Preferred Reporting Items for Systematic Meta-Analyses) guidelines were used. The risk of bias was evaluated with the Cochrane Collaboration’s “risk of bias” tool, and the quality of evidence was graded according to Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Randomized controlled trials investigating differences between surgery and nonoperative treatment for displaced MCFs were included. The primary outcome was the nonunion rate. Other outcomes analyzed were time to union and to return to activities, Constant score, and Disabilities of the Arm, Shoulder and Hand (DASH) index. Patients’ satisfaction, secondary operations, and complications were also recorded. Results: Out of 832 records found, 14 randomized controlled trials with 1546 patients were included. A significantly lower risk ratio was found for nonunion (10%; 95% CI, 6%-18%, P < .001) favoring surgery. Time to union was 5.1 weeks shorter with surgery ( P = .007). The complication rate (including the number of reinterventions) was higher in the surgical group (31.3% vs 20.5%, P < .001). Shoulder function at short-term follow-up was significantly better in the surgical group (DASH index mean difference = 4.0 points), while no statistical difference was found in the Constant score and in the DASH index at midterm follow-up ( P = .41 and .80, respectively). At long-term follow-up, both shoulder functional scores were significantly better in the surgery group: the overall Constant score mean difference was 5.3 points (95% CI, 2.3-8.4 points; P < .001), and the DASH index mean difference was 4.3 points (95% CI, 0.2-8.4 points; P = .04). Conclusion: Surgical treatment of MCFs significantly reduces the nonunion rate and shortens the time to union as compared with the nonoperative approach and, despite a slightly higher incidence of complications, leads to better shoulder functional scores at short- and long-term follow-up. Further studies should address the clinical significance of the documented improvement.
Invalidating elbow contractures, a frequent problem after injury, are commonly treated by physical therapy or surgical release. In both cases, results can be frustrating: physical therapy is often not sufficient to gain functional range of motion, and after surgical release it is common to lose part of the motion gained in operating room. Thanks to the viscous-elastic properties of the soft tissue, the mobilization elbow braces can stretch the retracting or retracted tissues inducing a biological lengthening of collagen fibres. In post-traumatic contracture, mobilization braces are effectively employable in two main critical situations: to treat recent onset contractures which do not respond to simple physical therapy and to help in preserving range of motion gained after surgical release. We report our experience with mobilization brace used in 42 patients, 5 for post-traumatic contracture, 4 for contracture following articular fracture fixation and 33 after surgical release. Classification, indications and treatment protocols of the mobilization braces utilized are reported.
Interest is increasing in biological scaffolds for tissue regeneration such as extracellular matrix membranes, developed through soft tissue decellularization. Extracellular matrix membranes were developed to heal different tendon and soft tissue lesions that are very frequent in the general population with high health-care costs and patient morbidity. The aim of this research was to evaluate a human dermal matrix (HDM) decellularized by a chemico-physical method. A primary culture of rat tenocytes was performed: tenocytes were seeded on HDM samples and on polystyrene wells as controls (CTR). Cell viability and synthetic activity were evaluated at 3 and 7 days. An in vitro microwound model was used to evaluate HDM bioactivity: after tenocyte expansion, artificial wounds were created, HDM extracts were added, and closure time and decorin synthesis were monitored histomorphometrically at 1, 4, 24, and 72 hr. A significant higher amount of collagen I was observed when cells were cultured on HDM in comparison with that on CTR (3 days: p < 0.0001; 7 days: p < 0.05). In HDM group, fibronectin synthesis was significantly higher at both experimental times (p < 0.0001). At 3 days, proteoglycans and transforming growth factor-β1 releases were significantly higher on HDM (p < 0.0001 and p < 0.005, respectively). The artificial microwound closure time and decorin expression were significantly enhanced by the addition of 50% HDM extract (p < 0.05). In vitro data showed that the decellularization technique enabled the development of a matrix with adequate biological and biomechanical properties.
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