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Osteochondral Allograft (OCA) Kit

Zimmer Biomet’s OCA Kit contains fresh young allograft cartilage and cancellous chips. It is intended to provide surgeons with an early-intervention option to treat osteochondral defects and restore articular cartilage for the knee, hip, ankle and upper extremities.

Advantages of using the OCA Kit include:

  • Young allograft cartilage contains 10x greater chondrocyte density than adult tissue and does not elicit an allogeneic immune response1-3*
  • The graft is implanted in a single stage procedure with fibrin fixation
  • No need to harvest a periosteal flap
  • No need to harvest tissue or cells from areas of undamaged cartilage
  • Zimmer Biomet’s young allograft cartilage has shown to:
    • Have 85% survivorship at 5 years4
    • Significantly reduce pain and improve function for at least 5 years associated with cartilage damage in the knee4,5

Compared with adult cartilage, bovine cartilage harvested from young bovine demonstrated:6

  • 1.8 fold greater cell density (P=.004)
  • 1.5 fold higher cell proliferation rate (P=.001)
  • 1.7 fold increase in cells detected that had migrated and proliferated on the margin of cut cartilage (P=.006)
  • Elevated Glycosaminoglycan (GAG) content in both native and cultured tissues
  • Only juvenile cartilage was able to generate new cartilaginous tissues which contained type II collagen not type I (Fig. 1)
JB-Fig-7-A-edit1
A
JB-Fig-7-C-edit1
C
JB-Fig-7-B-edit1
B
JB-Fig-7-D-edit1
D

Fig. 1. The new tissues generated from juvenile bovine cartilage exhibited strong labeling of type II collagen and proteoglycan with no detectable type I collagen. (A) H & E, (B) Safranin-O, (C) Type II collagen and (D) Type I collagen.

Compared with adult cartilage, human cartilage from young donors demonstrates:

  • Chondrocytes can generate new tissue (extracellular matrix) along the edges of the original cartilage tissue7
  • in vitro studies show 100x more activity than adult chondrocytes in producing cartilage matrix1,2  
  • Cartilage matrix produced demonstrates hyaline characteristics including high collagen type II and type IX and no detectable type I1,2  

A study of 25 subjects with knee cartilage lesions treated with Zimmer Biomet live articular cartilage demonstrated that patients experienced a significant reduction in symptoms associated with cartilage damage, including knee pain, and improvement in function and sports activities at two years following surgery(*p<0.05).5

,ZIM418 Charts

Fig. 1. Knee Injury and Osteoarthritis Outcome Survey (KOOS) results for 25 study subjects at 24 months. Elective arthroscopy was completed on 11 of these subjects 24 months following surgery.

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40046-preop-open-arthot-crop

Fig. 2. Preoperative arthroscopy photo of 3.4cm2 medial femoral condyle lesion in a 38 year old male with history of failed prior microfracture (left). Lesion debrided during open arthrotomy (right).

40046-DeNovo-open-arthrot-IMG-021-crop
40046-24-mo-scope-IMAGE-1-8-crop

Fig. 3. Lesion filled with Zimmer Biomet young allograft cartilage during surgery (left). Elective arthroscopy at 24 months shows excellent fill with complete integration (right).

40032-24-mo-histology-edit1

Fig. 4. Biopsy and histological staining of a single patient whose two year post grafting sample scored well. This sample demonstrates good integration of hyaline cartilage, viable chondrocytes, high proteoglycan content and areas of immunopositivity for type II collagen

Zimmer Biomet conducted a Longitudinal Data Collection Clinical Study of articular cartilage lesions in the ankle treated with our young allograft cartilage. 8 205 subjects were enrolled but not all made it to the 5 year follow-up time due to early termination of the study.  The subjects had an average age of 37.8 ± 11.9 (range, 17 to 72) years, an average body mass index (BMI) of 29.3 ± 5.9 (range, 18 to 50) and 43 percent of the patients were female. Subjects underwent articular cartilage treatment with Zimmer Biomet young allograft cartilage an average of 6.3 ± 7.9 (range, 0 to 45.2) years after their initial ankle injury. Almost 59% of subjects (120) had at least one previous cartilage repair treatment including debridement, microfracture, osteochondral allograft or autograft, autologous chondrocyte implantation (ACI) and subchondral drilling.

Subjects completed a prescribed follow-up schedule of 6, 12, 18, 24, 36, 48 and 60. Clinical outcomes associated with symptoms of cartilage damage (as shown in the below graph) were collected at each visit. At termination, 72 subjects had reached follow-up of greater than 36 months including 32 subjects with follow-up at 60 months.8

Results demonstrated a graft survival rate of 89% at 5 years and subjects showed significant improvement in Average American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS) scores compared to baseline at all follow-up time intervals. 

ZIM418 Charts,

Fig. 5. Average American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS), Foot and Ankle Ability Measure (FAAM) activities of daily living score (ADL) and Sports score, and pain intensity measured on a 100 mm Visual Analog Scale (VAS Pain) scores for 129 ankles.

DeNovo-NT-at-5-mo-edit

Fig. 6. Arthroscopy photo above shows cartilage graft at 5 months post-op during a second look arthroscopy

For any inquiries regarding reimbursement, please contact Zimmer Biomet Reimbursement Hotline: Phone: 1-866-946-0444. Hotline Hours: Monday-Friday, 8am- 5pm, EST

Email: reimbursement@zimmerbiomet.com

Additional Information

  1. Adkisson, H. D., et al. The potential of human allogenic juvenile chondrocytes for restoration of articular cartilage. American Journal of Sports Medicine. 38(7):1324-33, 2010.  
  2. Federer, J., et al. The Promise of Chondral Repair Using Neocartilage. In Sandell, J. S., et al (red) Tissue Engineering in Musculoskeletal Clinical Practice. American Academy of Ortopaedic Surgeons. Chapter 22, pp. 219-226, 2004. 
  3. Adkisson, H. D., et al. Immune evasion by neocartilage-derived chondrocytes: Implications for biologic repair of joint articular cartilage. Stem Cell Research. 4:57-68, 2010.
  4. Data on file Zimmer Biomet. Post-Market, Longitudinal Data Collection Study of DeNovo® NT for Articular Cartilage Defects of the Knee, protocol number CSU2010-22B. Aug 14, 2017.
  5. Farr, J., et al. Clinical, Radiographic and Histological Outcomes following Cartilage Repair with Particulated Juvenile Articular Cartilage: A 2-Year Prospective Study. American Journal of Sports Medicine. 42(6):1417-25, 2014.
  6. Liu H., et al. Enhanced Tissue Regeneration Potential of Juvenile Articular Cartilage. American Journal of Sports Medicine. 41(11):2658-67, 2013.
  7. Tompkins, M., et al. Denovo NT Allograft. Operative Techniques in Sports Medicine. 21(2): 82-89, 2013.
  8. Data on file Zimmer Biomet. Post-Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated with DeNovo NT Natural Tissue Graft, protocol number CSU2010-21B. Nov 13, 2017.

*Cell assays are not necessarily indicative of clinical performance

 

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Zimmer, Inc.
1800 West Center Street
Warsaw, Indiana 46580 USA


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