Yao J.Q.,Zimmer Orthobiologics Inc.
Cartilage | Year: 2011
Objective: This case study of 4 patients followed for at least 2 years was conducted to evaluate a cartilage repair procedure that involves transplanting particulated juvenile allograft cartilage. Design: A multicenter, prospective, single-arm, 25-subject case study was designed to evaluate clinical outcomes such as IKDC and KOOS scores as well as the extent and quality of repair with MRI. In addition, there is an option for the transplants to be biopsied at various time points after implantation (up to 5 years). Currently, 25 patients with 1 or 2 chondral lesions on the femoral condyles and trochlea have been enrolled and treated in the prospective study. Results: The first 4 patients have completed an evaluation at 24 months postoperative follow-up. Improvements in clinical outcomes over the preoperative baseline data have been observed. Conclusions: The present report describes, for the first time, clinical intermediate-term results of a novel cartilage repair procedure that involves transplanting particulated juvenile cartilage tissue allograft into prepared cartilage lesions of the femoral condyles and/or trochlea. Clinical outcome data of 4 patients who have reached the 24-month postimplantation milestone indicate early positive outcomes and suggest that this technique is capable of improving clinical symptoms. MRI data suggest that defect filling is possible and persists to at least 2 years. Continued clinical evaluation of this technique is needed with extended follow-up of all 25 patients in the series. © The Author(s) 2011. Source
Farr J.,OrthoIndy |
Tabet S.K.,New Mexico Orthopedics |
Margerrison E.,Zimmer Orthobiologics Inc. |
Cole B.J.,Rush University Medical Center
American Journal of Sports Medicine | Year: 2014
Background: Biological repair of cartilage lesions remains a significant clinical challenge because of the lack of natural regeneration and limited treatment options. Hypothesis: Treatment of articular cartilage lesions in the knee with particulated juvenile articular cartilage (PJAC) will result in an improvement in patient symptoms of pain and function and magnetic resonance imaging (MRI) findings at 2 years compared with baseline. Study Design: Case series; Level of evidence, 4. Methods: Patients with symptomatic articular cartilage lesions on the femoral condyles or trochlear groove of the knee were identified for treatment with PJAC. There were 25 patients with a mean age of 37.0 ± 11.1 years and a mean lesion size of 2.7 ± 0.8 cm 2. All patients were assessed preoperatively (baseline) with a knee examination and surveys including the International Knee Documentation Committee (IKDC) subjective knee form, 100-mm visual analog scale (VAS) for pain, and Knee injury and Osteoarthritis Outcome Score (KOOS). Patients were followed at predetermined time points postoperatively through 2 years. Also, MRI was performed at baseline and at 3, 6, 12, and 24 months. At 2 years, patients were given the option of undergoing voluntary diagnostic arthroscopic surgery with cartilage biopsy to assess the histological appearance of the cartilage repair including safranin O staining for proteoglycans and immunostaining for type I and II collagen. Results: Clinical outcomes demonstrated statistically significant increases at 2 years after surgery compared with baseline, with improvements seen as early as 3 months. Over the 24-month follow-up period, the IKDC score increased from a mean of 45.7 to 73.6, KOOS-pain score from 64.1 to 83.7, KOOS-symptoms score from 64.6 to 81.4, KOOS-activities of daily living score from 73.8 to 91.5, KOOS-sports and recreation score from 44.6 to 68.3, and KOOS-quality of life score from 31.8 to 59.9. The MRI results suggested that T2-weighted scores were returning to a level approximating that of normal articular cartilage by 2 years. Histologically, the repair tissue in biopsy samples from 8 patients was composed of a mixture of hyaline and fibrocartilage; immunopositivity for type II collagen was generally higher than for type I collagen, and there appeared to be excellent integration of the transplanted tissue with the surrounding native articular cartilage. Other than elective biopsies, there were no reoperations, although 1 graft delamination was reported at 24 months. Conclusion: This study demonstrates a rapid, safe, and effective treatment for cartilage defects. For the patient population investigated, the clinical outcomes of the PJAC technique showed a significant improvement over baseline, with histologically favorable repair tissue 2 years postoperatively. © 2014 The Author(s). Source
Zimmer Orthobiologics Inc. | Date: 2011-11-15
A bone void filler composition is described containing an acidic mineral component that contains a calcium source and a phosphate source or a lower alkyl carboxylate source; an osteoinductive component that contains demineralized bone; and a three-dimensional, osteoconductive biologically acceptable carrier component that contains a collagenous material. The bone void filler composition may be in the form of a sponge or in the form of a paste or putty used to form a sponge or is obtained from particulated sponge, or that forms after a sponge is rehydrated. A pre-mixed bone void filler composition is described containing the acidic mineral component or the lower alkyl carboxylate source; the osteoinductive component; and a biologically acceptable carrier component that contains a liquid carrier. Methods of making and using the compositions are also described. The ratio of demineralized bone component to acidic mineral component may range from about 0.5:1 to about 80:1.
Zimmer Orthobiologics Inc. | Date: 2012-03-21
Medical devices for cutting and suturing biological tissue generally include a shaft and first and second guide members each including a first portion coupled to the shaft at a first location and a second portion coupled to the shaft at a second location. The first portions are movable along the shaft relative to the second portions, and the first and second guide members define an arcuate profile and are configured to flex in response to such movement. When used to cut tissue, the medical device may further include a blade positioned between the first and second guide members. When used to suture tissue, one or more suture guides may be provided on the first guide member for directing a suture needle through tissue proximate the first guide member. Methods of repairing and replacing a meniscus using the medical devices are also provided.
Zimmer Orthobiologics Inc. | Date: 2012-03-23
The invention provides a composition including isolated small living tissue particles, a method of making the tissue particles, and a method of using the composition to ameliorate a tissue defect. The tissue particles are composed of cells and their associated extracellular molecules and are sized, in certain embodiments, to be smaller than about 1 mm. Another aspect of the inventive tissue particles is the large percentage of viable cells. In certain embodiments, the tissue particles are made from cartilage and the composition may also contain additives such as adhesives, solutions, and bioactive agents.