RegJoint

RegJoint

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SKU: SMAGRG0001

€500,00

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    Description

    Innovative bioresorbable joint replacement for modern orthopedics
    What is RegJoint™?

    RegJoint™ is an advanced, bioresorbable implant specifically designed for painful small joints in the hand and foot. Made from highly porous polylactide (PLDLA), it is naturally absorbed by the body while supporting the formation of a new functional joint.

    Technical Details

    The Institute of Biomaterials at Tampere University of Technology, in collaboration with Bionx (later Linvatec Biomaterials Ltd., Finland, now Scaffdex/Finland), developed this biodegradable spacer from poly-L/D-lactide copolymer with an L/D-monomer ratio of 96/4 (PLDLA).

    The material is spun into four-ply very thin threads, which are then knitted into a tube. This tube is then rolled up like a fire hose and processed into a cushion of various sizes and thicknesses.

    Available Sizes 9 sizes in 2 mm increments (8-24 mm diameter)
    Thickness 3.6-4.5 mm
    Pore Size 100-400 µm
    Material Poly-L/D-lactide copolymer (PLDLA)
    CE Certification Since November 2011
    Key Advantages:
    Completely Biodegradable

    Natural degradation in the body into water and carbon dioxide within 2-3 years.

    New Pseudo-Joint

    Promotes the formation of new, functional tissue that serves as a joint.

    Function Preservation

    Maintains joint function and natural limb length after surgery.

    Pain Relief

    Proven significant reduction in pain for patients.

    Flexible Surgical Options

    Can be performed on an outpatient or inpatient basis.

    Low Complication Rate

    Uncomplicated and low-complication surgical method, confirmed by over 10 years of clinical experience.

    How does it work?

    RegJoint™ uses the body's natural healing process in an innovative way. After implantation, the porous structure serves as a scaffold for ingrowing tissue. After about three months, flexible connective tissue forms, serving as a functional joint and enabling natural mobility.

    In vitro studies show that the PLDLA used has a structural resorption of 50% after 13 weeks, which is long enough for the ingrowth of the body's own tissue. The implant is simultaneously slowly resorbed by the body and completely broken down into water and carbon dioxide within 2-3 years, leaving no residue.

    Ideal for patients with:
    • Rheumatoid arthritis in small joints
    • Osteoarthritis in small joints of the hand and foot
    • Painful hand and foot joints with limited mobility
    • Köhler's disease 2 (osteonecrosis of the metatarsal head)
    • Calcanonavicular coalition
    Application Examples
    MTP 1 Joint in Osteoarthritis

    Established in resection interposition arthroplasty of the MTP 1 for osteoarthritis and rheumatoid arthritis. Statistical analysis of the 5-year follow-up showed significant advantages regarding pain, function, and AOFAS score.

    Köhler's Disease 2

    For the treatment of osteonecrosis of the metatarsal head, first described in 1914 by US surgeon Freiberg. The disease occurs in 60-88% of cases in metatarsal 2 and is more common in females.

    Calcanonavicular Coalition

    Good experience as an alternative to conventional fat interposition in the treatment of calcanonavicular coalition.

    Clinically Proven

    The first human implantation took place in Finland in 1997 without implant-related complications. A comprehensive multicenter study from 2001, which led to the CE certification of the product, demonstrates the significant advantages of RegJoint™ over conventional surgical methods in terms of pain reduction and functionality.

    In patients with simultaneous treatment of metatarsals 1-5, a significant advantage of RegJoint® was demonstrated for the parameters pain (VAS), function (VAS), and AOFAS score after 5 years. Long-term observations over more than 10 years confirm the sustainable results and the significant improvement in quality of life after the procedure.

    Important Note:

    For optimal results, the porous structure of the implant must be carefully preserved during surgery. The specific nature of the material is crucial for successful tissue integration and the formation of the functional pseudo-joint.

    Pros and cons

    • for the surgical treatment of osteoarthritis
    • other degenerative or inflammatory conditions of the small joints of the hand
    • foot
    • especially when pain
    • stiffness affect the quality of life
    • other methods such as arthrodesis or prostheses are to be avoided

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