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Published on : Jul 20, 2021 | Views : 2779 | Downloads : 6

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Slide 1-

Meniscal Repair
Slide 2-

Anatomy and Physiology of the Meniscus Articular cartilage acts as a friction reducer Meniscal cartilage acts as a cushion to absorb shock
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Meniscus Medial Lateral Ligaments ACL PCL MCL LCL The components of your knee, along with the muscles of your leg, work together to manage the stress your knee receives as you walk, run and jump. http://www.athleticadvisor.com/Injuries/LE/Knee/knee_anat.htm
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Semi-Lunar shape Fibrocartilage Meniscus
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72% water 60-70% collagen (dry weight) 2-3% GAG (glycosaminoglycans) (dry wt) Type I and Type II collagen Fibrochondrocytes Anisotropic: Circumferential & Radial fibers Vascular and avascular zones SP Arnoczky et al. 1985 Red and White zones
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AufderHeide and Athanasiou 2004 Red zone White zone  Meniscal Cells: Fibrochondrocytes Fibroblast Chondrocytes 
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Damage of the Meniscus
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Normal Damaged Two most common causes of damage to the meniscus: Traumatic injury Degenerative processes Injury
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Longitudinal Complete bucket-handle Incomplete Oblique Radial (Transverse) Horizontal Usually degenerative Injury www.orthoassociates.com/
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Repair of the Meniscus
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Meniscectomy: Partial and Total Changes in contact area and stress distribution contribute to osteoarthritis (OA) Meniscal repair: Sutures and implants Does not heal in avascular zone Allograft implantation: Transplant issues Poor fixation technique Difficulties with finding a donor of correct size Future Options: SIS and CIS Repair
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Partial Arthroscopic procedure Minor trimming of a frayed edge to anything short of removing the rim Evidence for partial regeneration? Complete Open or arthroscopic procedure Removing a complete meniscus, that is a medial or a lateral meniscus, right to the meniscal rim Arthritis Meniscectomy
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Fig. 1. The tested implants magnified 200%: Fastener Meniscal Screw Dart Meniscus Arrow Becker et al. 2001 Stinger T-Fix, and Ethibond 2/0 suture. Sutures and Implants Steadman-Hawkins Clinic Resorbsorbable devices http://www.youtube.com/watch?v=M-FQGMPfGac
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Types: Permanent* (pref. for sutures) Biodegradable Barber & Herbert, 2000 500,000 cases/year deemed “non-repairable” Sutures stronger than implants.
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Only applicable in approximately 10 % of tears Not applicable in degenerative tears Lower healing rate without concomitant ACL reconstruction 50-80% (promoted healing with more invasive surgery like ACL repair) Failure to heal often leads to partial meniscectomy Device failures: can migrate out of tissue or break Arnoscky & Lavagnino, 2001
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Indications Patients that have had meniscectomy Patients with pain and discomfort associated with osteoarthritis Patients undergoing ACL reconstruction for increased stability Athletes for determent of osteoarthritis development Preservation techniques Fresh Freeze-Dried Cryo-preserved Concerns Meniscal Allograft Transplants (MAT)
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Farr and Cole; Arthroscopy 2004 Bone Bridge in Slot Loose bridge in slot allows condyle capture to aid in optimal anteroposterior placement Guide prepares slot parallel to tibial slope Fixation independent of bridge placement J Farr et al 2004 MAT-Bone Bridge
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Courtesy Dr. Farr, CRCI MAT-Bone Bridge
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MAT-Bone Bridge
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Failure to capture femur Proper capture of femoral condyle J Farr, W Gersoff 2004 Proper size and position allows:“capture” of femoral condyle MAT-Size and Position
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MAT: Medial Bone Bridge in Slot Allograft Intact Medial Meniscus Menisectomy Farr and Cole Lab: TekScan Stress Measurement: 1000 Newton peak load; peak pressure 7 Mpa Courtesy Dr. Farr Biomechanically, Medial MAT improves stress distribution MAT-Biomechanical Function
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Availability Reproducibility/Accuracy of Sizing Lack of control over final cellular and extracellular matrix composition/ mechanical properties Potential for disease transmission Survivorship Variation of Surgical Technique/ Placement MAT-issues
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Transplant is immunopriveliged -No immunosuppressants Avascular meniscus has been frozen-Decreased viability Inflammatory response Disease transmission risk (eg. HIV risk 1/Million) Meniscus may or may not be fully repopulated by patient May be a variable duration on how long meniscus transplantation is going to last for enough repopulation Degenerative types of tearing can happen Need for additional surgery MAT-issues
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Current technique allows reproducible implantation of both medial and lateral menisci MAT effective in the intermediate term for decreasing pain (medial and lateral) Long-term effect on articular cartilage is under evaluation
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Preserve biomechanical joint function Prevent post meniscectomy chondrosis Reestablish chondro-protective function Regeneration of cell type producing extracellular environment duplicating original meniscus Alleviate symptoms (primarily pain) Durable Summary: mimic the natural meniscus Courtesy Dr. Farr Meniscal Substitues
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Manipulated Meniscal Allograft * Collagen Meniscal Implant (CMI) * * Small Intestine Submucosal (SIS) Implant * Adult Mesenchymal Stem Cell Implants * Tissue Engineered Meniscus: Scaffolds + Cells * Tissue Engineered Meniscus: Cell-based Therapies Tissue Engineered Meniscus: Gene Therapies Courtesy Dr. Farr Meniscal Substitutes
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Cell Goals: Three Overlapping Cell Types Elongated fibroblast-like: more Type I collagen producing Polygonal: mixed function/support Chondrocyte-like: more GAG producing Courtesy Dr. Farr
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Scaffold Goals: Biocompatible and biodegradable in the long term Unrestricted cell growth and free diffusion of nutrients Adherence and controlled release of growth factors Mechanical structure to withstand initial joint forces Controlled degradation: initial ingrowth of new tissue and then remodeling to local environment Porosity: Optimal pore size 150-500 microns communication (Buma 2004) Courtesy Dr. Farr
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Natural Collagen: variety of types and preparations Periosteum/ Perichondrium Tendon/ Fascia Meniscal Tissue Synthetic PGA/ PLA Hydrogels Polyurethane Courtesy Dr. Farr
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Courtesy WG Rodkey Processed Bovine Achilles Tendon Trimmed, Minced, Washed Purified: Salt, Acid, Enzymes Filtered, Washed, Freeze-Dried Molded and Crosslinked Lyophilized Collagen MeniscaI Implantation (CMI)
Slide 31-

Partial meniscus loss (Medial only at present) Need to have an intact rim of meniscus over entire length No unstable segments Lesion in red/red or red/white zone Not suitable for total meniscus replacement No uncorrected axial malalignment Appropriate Lesions
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Indications Medial meniscus Intact rim < Grade III US Trial: Steadman JR, Rodkey WG. Tissue-engineered CMIs: 5 to 6-year feasibility study results. Arthroscopy 21: 515-525, 2005 Courtesy WG Rodkey
Slide 33-

Courtesy WG Rodkey Phase II-6 Months Post-Op
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Most Have Moderate to Extensive Filling Dense Fibrous Connective Tissue Most Have Extensive Fibrochondral Tissue Some Dense,Near Normal,Meniscus-Like Tissue Maturation Process Ongoing Courtesy WG Rodkey Histology 6-12 Months Post-Op
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Courtesy WG Rodkey 6.3 Years Post-Op
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Courtesy WG Rodkey 6.3 Years Post-Op
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US Feasibility Studies 18 US Multicenter Trials ~150 EU Multicenter Trials ~100 Japan Trials ~ 15 EU/AUS Open Market Use ~1700 Approximate Worldwide Total ~2000 Courtesy WG Rodkey Medial CMI Totals
Slide 38-

Regen Biologics, Franklin Lakes, New Jersey, USA-Went bancrupt Founded in 1990, ReGen Biologics is a biological remodeling company that develops and manufactures implants and medical devices for the regeneration and repair of tissue. Preclinical and Clinical Studies Available Clinically available in Europe Company filed for chapter 11 in 2011 after FDA rescinded approval and wanted more safety and efficacy trials
Slide 39-

The data from the Rodkey study was used by the U.S. Food and Drug Administration (FDA) in the 510(k) application process for the Menaflex collagen meniscus implant. An FDA executive summary of the Rodkey data indicated that patients who received the collagen meniscus implant followed a different post-op protocol than the control group and control patients were not required to undergo a planned second-look arthroscopy since it was assumed that there was no tissue regrowth in these patients. The FDA also indicated that more meniscal tissue was removed from the collagen meniscus implant patients than in the control patients. The FDA noted that the re-look arthroscopy results for collagen meniscus implant group showed that 16% of evaluated devices were not firmly attached to the host rim and 18% of knee compartments were determined to be worse than during the operative procedure at the time of the re-look arthroscopic procedure.
Slide 40-

Clinically it has been shown that the collagen implant shrinks in time (Cummins et al. 1997, Ibarra et al. 1998) Source for tissue ingrowth: native meniscus The outer rim must be in place Initial mechanical material properties poor The outer rim must be in place (for fixation of scaffold) Issues
Slide 41-

DePuy Biologics, Warsaw, Indiana, USA Preclinical Studies; Phase 1/2 clinical research Prepared and molded SIS SIS composed of: Collagen Types Growth Factors Segmental posterior horn, medial meniscus Animal Studies, Cook et al Small Intestine Submucosa (SIS)
Slide 42-

Courtesy Jimi Cook SIS: Porcine
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Cook JL, et al. Am J Sports Med, 1999Cook JL, et al. Tiss Eng, 2001 Courtesy Jimi Cook SIS
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**SIS = MORE TISSUE** SIS Wedge Meniscectomy Courtesy Jimi Cook 6 Months Post-Op
Slide 45-

TE meniscus: PGA/PLLA mesh seeded with fibrochondrocytes, shaped like medial meniscus of adult sheep; transplantation into sheep -meniscal-like tissue formation + = Courtesy Jimi Cook Ibarra et al. 1998 Tissue Engineering Approaches
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UC Davis, College of Engineering, BMEAthanasiou Lab Recently, we have pioneered the use of self-assembly to create functional constructs without the use of scaffolds. Self-assembly has been improved by applying exogenous stimuli such as hydrostatic pressure and growth factors to enhance construct functional properties. Additionally, alternate cell sources including dermis-derived cells and human embryonic stem cells have been investigated to make this technology more translatable.
Slide 47-

Chondroprotection is primary endpoint, through: Reproduction of cell populations to reestablish stratified composite nature of natural meniscus Long-term survivorship Additional Goals: Ease of procedure to patient and surgeon Affordable to health care system
Slide 48-

Anesthesia Infection (Superficial and Deep) Blood Clott (Deep vein thrombosis) Vascular Injury (Popliteal arteries) Nerve Injury (Peroneal nerve, saphenous nerve) Arthrofibrosis (Excessive scar tissue formation) Complex regional pain syndromes Inappropriate healing (Inadequate scar tissue formation) Possible Re-operation Improper alignment of implant Migration of implant With arthroscopic procedures, major complications are very rare (Small et al. 1988) Proper training of surgeons needed to ensure successful implantation Byod & Myers, 2003 The Bad and the Ugly
Slide 49-

Degradation products accumulate at implant site Delayed inflammatory response (Törmälä et al.; Athanasiou et al. 1998) Polyurethane & Teflon meniscus prosthesis Fragentation of non-resorbable materials may induce macrophage & giant cell reactions, synovial irritation, cartilage softening (Buma et al. 2004) PGA/PGLA relatively poor mechanical properties Absorbable sutures: loss of mechanical strength The Bad and the Ugly (Cont.)