We conclude that in this initial cohort, arthroscopic implantation of InSpace™ system represented an effective alternative to the existing arthroscopic procedures in patients with painful massive RCT refractory to conservative management. Further randomized controlled trials comparing the clinical and functional outcomes after implantation of the InSpace™ device are warranted.

BACKGROUND The number of existing wrinkle assessment scales makes it difficult to compare the efficacy of cosmetic techniques in rejuvenating photoaged skin. A single and simple assessment scale that reliably quantifies wrinkle depth is needed.

The use of biodegradable materials is gaining popularity in medicine, especially in orthopedic applications. However, preclinical evaluation of biodegradable materials can be challenging, since they are located in close contact with host tissues and might be implanted for a long period of time. Evaluation of these compounds requires biodegradability and biocompatibility studies and meticulous pathology examination. We describe 2 preclinical studies performed on Sprague-Dawley rats for 52 weeks, to evaluate clinical pathology, biocompatibility, biodegradability, and systemic toxicity after implantation of 2-layered films or saline-inflated balloon-shaped implants of downsized InSpace™ devices (termed ''test device''). The test devices are made from a copolymer of poly-L-lactide-co-e-caprolactone in a 70:30 ratio, identical to the device used in humans, intended for the treatment of rotator cuff tears. Intra-articular film implantation and subcutaneous implantation of the downsized device showed favorable local and systemic tolerability. Although the implanted materials have no inherent toxic or tumorigenic properties, one animal developed a fibrosarcoma at the implantation site, an event that is associated with a rodent-predilection response where solid materials cause mesenchymal neoplasms. This effect is discussed in the context of biodegradable materials along with a detailed description of expected pathology for biodegradable materials in long-term rodent studies.

BACKGROUND The use of bovine collagen implants for dermal contour correction is associated with a 3% to 5% incidence of hypersensitivity, which necessitates pretreatment screening by an intradermal skin test. OBJECTIVE The objective was to determine the incidence of hypersensitivity with the recently developed cross‐linked, porcine collagen implant, EVOLENCE (ColBar LifeScience Ltd.), which is used intradermally for correction of rhytids and scars. MATERIALS AND METHODS Enrolled subjects (n=530) received an intradermal injection of 0.1 mL EVOLENCE implant in the left forearm and a second injection in the right forearm after 2 weeks. Injection sites were assessed clinically at 30 minutes and 72 hours after each injection and at 30 days after the second injection. Serum anticollagen antibody determinations were performed at screening and at the end of the study. RESULTS Study assessments were completed by 519 subjects. No significant erythematous reactions suggestive of positive hypersensitivity were observed. Most subjects did not display antibodies against porcine Type I collagen at any time, and those who did showed no changes in levels during the study. The single‐sided 95% upper confidence limit for the possibility of moderate‐to‐severe erythematous reactions with the EVOLENCE implant was determined as 0.58% of subjects. CONCLUSION Because the EVOLENCE implant has a low potential for hypersensitivity, intradermal skin testing before its use appears unnecessary.

Because the EVOLENCE implant has a low potential for hypersensitivity, intradermal skin testing before its use appears unnecessary.