In June 2009 Scaffdex and Conmed Linvatec Biomaterials signed a licensing agreement of commercialization and clinical data of joint implant innovation. Initially this innovation was created in research collaboration of orthopedic surgeons of Tampere University Hospital and Tampere University of Technology, Institute of Biomaterials, which is currently part of Department of Biomedical Engineering.
RegJoint™ implant acts as a spacer in small joints in hand and foot and is gradually replaced by patient´s own fibrous tissue, forming a natural fibrous neojoint between the bone ends. It has been tested extensively in vivo and in clinical trials. RegJoint™ is made of biodegradable poly-96L/4D-lactide copolymer, its´ porous structure is suitable for ingrowth of patient´s own fibroblasts and no separate cell manipulation or culturing is needed prior the operation.
RegJoint™ is CE marked, product portfolio is introduced in the table below.
RegJoint™ product selection
|
Ref |
Diameter (mm) |
Height (mm) |
|
RG0001 |
8 |
3.6 |
|
RG0002 |
10 |
4.0 |
|
RG0003 |
12 |
4.0 |
|
RG0004 |
14 |
4.5 |
|
RG0005 |
16 |
4.5 |
|
RG0006 |
18 |
4.5 |
For further information, surgical technique and ordering information, please, contact Minna Leppänen, minna.leppanen@scaffdex.com or Tuija Annala, tuija.annala@scaffdex.com
RegJoint™ publications
Honkanen PB, Kellomäki M, Lehtimäki MY et al. Bioreconstructive joint scaffold implant arthroplasty in metacarpophalangeal joints: short-term results of a new treatment concept in rheumatoid arthritis patients. Tissue Eng. 2003, 9: 957–65
Honkanen PB, Kellomäki M, Konttinen Y, Mäkelä S, Lehto M: A Midterm Follow-Up Study of Bioreconstructive Polylactide Scaffold Implants in Metacarpophalangeal Joint Arthroplasty in Rheumatoid Arthritis Patients. The Journal of Hand Surgery (European Volume, 2009) 34E: 2: 179–185
Ikävalko M, Skyttä E, Belt E: One-Year Results of Use of Poly-L/D-Lactic Acid Joint Scaffolds And Bone Packing in Revision Metacarpophalangeal Arthroplasty. Journal of Hand Surgery (European Volume, 2007) 32E: 4: 427–433
Lehto MUK, Lehtimäki MY. A novel MCP-arthroplasty in rheumatoid arthritis – from resorbable material to fibrous cushion. VII Congress of the European Rheumatoid Arthritis Surgical Society, Amsterdam 1995.
Kellomäki M, Törmälä¨ P. Processing of resorbable poly-a-hydroxyacids for use as tissue-engineering scaffolds. In: Hollander AP, Hatton PV (Eds.) Methods in molecular biology. The Human Press Inc., 2003, Vol. 238: 1–10.Kirschenbaum D, Schneider L
Mai S, Mai B: Ein- bis Zwei-Jahreserfahrungen mit einem neuen biodegradierbaren Implantat für kleine Gelenke. Orthopädische Praxis 43, 4, 2007: 159-167
Waris E, Ashammakhi N, Lehtimäki M et al. The use of biodegradable scaffold as an alternative to silicone implant arthroplasty for small joint reconstruction: an experimental study in minipigs. Biomaterials. 2008a, 29: 683–91.
Waris E, Ashammakhi N, Lehtimäki M et al. Long-term bone tissue reaction to polyethylene oxide/polybutylene terephthalate copolymer (Polyactive) in metacarpophalangeal joint reconstruction. Biomaterials. 2008b, 29: 2509–15.