Effectiveness of an acellular synthetic matrix in the treatment of hard-to-heal leg ulcers.

Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population. Despite improvements in wound care, some wounds will not heal and they present a significant challenge for patients and health care providers. A multi-centre cohort study was conducted to evaluate the effectiveness and safety of a synthetic, extracellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal venous or mixed leg ulcers. Primary effectiveness criteria were (i) reduction in wound size evaluated by percentage change in wound area and (ii) healing assessed by number of patients healed by end of the 12 week study. Pain reduction was assessed as a secondary effectiveness criteria using VAS. A total of 45 patients completed the study and no difference was observed between cohorts for treatment frequency. Healing was achieved in 35·6% and wound size decreased in 93·3% of patients. Median wound area percentage reduction was 70·8%. Over 50% of patients reported pain on first visit and 87·0% of these reported no pain at the end of the study. Median time to first reporting of no pain was 14 days after treatment initiation. The authors consider the extracellular synthetic matrix protein an effective and safe adjunct to standard care in the treatment of hard-to-heal leg ulcers.

Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes.

BACKGROUND: A novel, biodegradable, polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with painful irreparable partial meniscal defects. HYPOTHESIS: The use of an acellular polyurethane scaffold for new tissue generation in irreparable partial meniscal defects provides both pain relief and improved functionality. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Fifty-two patients with irreparable partial meniscal defects (34 medial and 18 lateral, 88% with 1-3 previous surgeries on the index meniscus) were implanted with a polyurethane scaffold in a prospective, single-arm, multicenter, proof-of-principle study. Safety was assessed by the rate of scaffold-related serious adverse events (SAEs) and the International Cartilage Repair Society articular cartilage scoring system comparing magnetic resonance imaging (MRI) at 24 months to MRI at baseline (1 week). Kaplan-Meier time to treatment failure distributions were performed. Clinical outcomes were measured comparing visual analog scale, International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Lysholm scores at 24 months from baseline (entry into study). RESULTS: Clinically and statistically significant improvements (P < .0001) compared with baseline were reported in all clinical outcome scores (baseline/24 months): visual analog scale (45.7/20.3), International Knee Documentation Committee (45.4/70.1), KOOS symptoms (64.6/78.3), KOOS pain (57.5/78.6), KOOS activities of daily living (68.8/84.2), KOOS sports (30.5/59.0), KOOS quality of life (33.9/56.6), and Lysholm (60.1/80.7), demonstrating improvements in both pain and function. The incidence of treatment failure was 9 (17.3%) patients, of which 3 patients (8.8%) had medial meniscal defects and 6 patients (33.3%) had lateral meniscal defects. There were 9 SAEs requiring reoperation. Stable or improved International Cartilage Repair Society cartilage grades were observed in 92.5% of patients between baseline and 24 months. CONCLUSION: At 2 years after implantation, safety and clinical outcome data from this study support the use of the polyurethane scaffold for the treatment of irreparable, painful, partial meniscal defects.

Tissue ingrowth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions.

BACKGROUND: A novel, biodegradable, aliphatic polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with irreparable partial meniscal lesions. HYPOTHESIS: Treatment of irreparable partial meniscal lesions with an acellular polyurethane scaffold supports new tissue ingrowth. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Fifty-two patients (with 34 medial and 18 lateral lesions) were recruited into a prospective, single-arm, multicenter, proof-of-principle study and treated with the polyurethane scaffold. The scaffold was implanted after partial meniscectomy using standard surgeon-preferred techniques for suturing. Tissue ingrowth was assessed at 3 months by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and at 12 months by gross examination during second-look arthroscopy, in the course of which a biopsy sample from the inner free edge of the scaffold meniscus was taken for qualitative histologic analysis. RESULTS: Tissue ingrowth at 3 months was demonstrated on DCE-MRI in 35 of 43 (81.4%) patients. All but one 12-month second-look (43 of 44 [97.7%]) showed integration of the scaffold with the native meniscus and all biopsy specimens (44) showed fully vital material, with no signs of cell death or necrosis. Three distinct layers were observed based on morphologic structure, vessel structure presence or absence, and extracellular matrix composition. CONCLUSION: The DCE-MRI demonstrated successful early tissue ingrowth into the scaffold. The biopsy findings demonstrated the biocompatibility of the scaffold and ingrowth of tissue with particular histologic characteristics suggestive of meniscus-like tissue. In conclusion, these data show for the first time consistent regeneration of tissue when using an acellular polyurethane scaffold to treat irreparable partial meniscus tissue lesions.