[B]PART II -- EXPERIMENTAL/INVESTIGATIONAL [/B]treatments.
(Please see disclaimers in post #1 of this thread. Most of these treatments are NOT FDA approved for ankle OCD treatment.)
These are not yet accepted by by most doctors as proven/mainstream treatments for ankle OCDs. Many involve some form of stem cells. Some of these treatments are not FDA approved for treating OCD of the ankle (some are not FDA approved for anything yet). Generally insurance will NOT cover anything classified as "Experimental" or "Investigational," though if you and your doctor appeal claiming that no other treatment will work and conventional treatments have failed, your insurance company [I]might[/I] cover it. In some cases, the experimental treatment can be combined with MF or OATS, and your insurance might cover the MF or OATS procedure but you will have to pay out of pocket for the experimental part. Procedures are listed in alphabetical order.
[LIST][*] [B]ACI[/B] = Autologous Chondrocyte Implantation. Bit of your own cartilage is removed and stored up to two years by a lab. If you decide to do ACI, the lab cultures your chondrocytes until they have 10 million then doctor injects them into the OCD defect under a stitched-on periosteal patch. Requires two surgeries; first arthroscopic and second open athrotomy or osteotemy. ACI using collagen membrane instead of periosteal patch may be a future option. [INDENT]o [U]Pros[/U]: Uses you’re your own chondrocytes, which might rebuild more/better articular (hyaline) cartilage than MF.
o [U]Cons[/U]: Requires two surgeries; second surgery is complicated; periosteal patch can overgrow (hypertrophy) and require 3rd surgery. Risk of pain at periosteum harvest site. Must limit weight/motion until implanted cells have “set.”
o [U]Examples[/U]: Carticel by Genzyme; ChondroCelect by Tigenix. For examples of ACI with scaffold/matrix--see "MACI" below. As of today, Carticel is FDA approved only for knee OCD.[/INDENT][*] [B]Articular paste graft[/B]--take a little healthy cartilage, grind into paste and smush into the defect site after microfracture. The MF releases marrow with MSCs but the paste adds chondrocytes and maybe helps convince the marrow MSCs to make hyaline cartilage instead of fibrocartilage.[INDENT]o [U]Pros[/U]: Might lead to higher quality MF repair; can be done arthroscopically if doctor can get to the defect site with scope.
o [U]Cons[/U]: Few doctors offer this. Weak clinical evidence that it is better than normal MF. (That doesn’t mean it’s not better, just that there is no rigorous proof that it’s better.)
o [U]Example[/U]: Stone Clinic in San Francisco[/INDENT][*] [B]BMAC[/B] (bone marrow aspirate concentrate)--Remove marrow from your iliac crest (pelvis), spin down to concentrate stem cells, then inject concentrate into joint. Not sure if inject into defect site or just into joint space and let the stem cells wander around looking for something to regenerate. Could be combined with bioabsorable scaffold, like synthetic bone.[INDENT]o [U]Pros[/U]: Uses your own stem cells. Only one surgery (plus big needle to get marrow).
o [U]Cons[/U]: Big needle in pelvis; requires expertise/equipment to spin marrow.[/INDENT][*] [B]HGH injections—[/B]Normal MF or OATS plus several injections of rHGH (recombinant human growth hormone) into joint. In theory promotes new vascular growth which releases more stem cells, generates better new cartilage, and leads to faster recovery.[INDENT]o [U]Pros[/U]: Might lead to faster recovery and better quality repair cartilage. rHGH is FDA approved for other uses.
o [U]Cons[/U]: Few doctors offer this; requires multiple injections over months. Not FDA approved for joint repair. More success reported using HGH in knees than ankles.
o [U]Example[/U]: Dr. Allan Dunn in Florida[/INDENT][*] [B]Juvenile minced cartilage [/B]from young cadaver donors should have more highly active chondrocytes and more MSCs than adult cartilage, leading to better repair. Glued into defect with fibrin glue. Sold by the packet; number of packets needed depends on defect size.[INDENT]o [U]Pros[/U]: Only one surgery required. Might generate better cartilage than MF.
o [U]Cons[/U]: Can't be done arthroscopically. Likely requires more doctor skill than MF but not as much as OATS.
o [U]Example[/U]: Zimmer's DeNovo NT; Denovo ET/Neocartilage from Zimmer and ISTO Technologies (in clinical trials). This is not an endorsement of any of these products.[/INDENT][*][B]MACI[/B] = Matrix-induced (or assisted) Autologous Chondrocyte Implant. Second generation of ACI, it seeds chondrocytes in an absorable scaffold or matrix (typically collagen, fibrin, or hyaluronic acid) glued into the defect with fibrin glue.[INDENT]o [U]Pros[/U]: Does not require periosteal membrane cover
o [U]Cons[/U]: Not FDA approved (clinical trials)
o [U]Examples[/U]: ChondroCelect, BioCart II, Cartilix, CAIS, Verigen MACI, NeoCart, Hyalograft, and Cartipatch. AFAIK
, none of these are FDA approved.[/INDENT][*] [B]MSC[/B] (Mesenchymal stem cells) are multipotent stem cells that can differentiate into several cell types including osteoblasts (bone building) and chondrocytes (cartilage building). Bone marrow contains MSCs, so both microfracture and BMAC attempt to recruit MSCs to do cartilage repair.[*] [B]PRP[/B] (platelet-rich plasma) is blood plasma with the RBCs/WBCs removed and the platelets concentrated. It doesn’t contain stem cells but releases growth factors and is traditionally injected into muscles or tendons to improve healing. Some studies suggest it could improve cartilage regeneration.[*] [B]Synthetic bone. [/B]A synthetic bone substitute (paste, powder, granules, strip, or plug) acts as a scaffold to convince body (we hope) to make the right kind of new bone and cartilage. Can be soaked with ACs (autologous chondrocytes), PRP, your own blood, or BMAC prior to implantation.[INDENT]o [U]Pros[/U]: One surgery, no disease risk, does not require bone harvest, and might regenerate better cartilage and/or new bone. Can be combined with stem-cell type treatments. Plugs are FDA approved for backfill of OATS harvest sites. Powder/paste/granules are FDA approved for other bone repair.
o [U]Cons[/U]: Not FDA approved for OCD. Plugs probably cannot be implanted arthroscopically on talus. Powder/paste/granules do not seem to be used much for OCD repair.
o [U]Examples[/U]: Tru-fit plugs/TRUKKOR system from Smith & Nephew; Osteoset from Wright Medical Technology; NovaBone from NovaBone; VITOSS from Orthovita; Pro-Osteon from Biomet; and Bi-Ostetic from Berkeley Advanced Biomaterials. Several other synthetic bone products exist. This is not an endorsement of any of these products.[/INDENT][/LIST]