Project: Development of a new biomaterial implant for the reinforcement and stabilization of small hand joints
Osteoarthritis (OA) is a chronic and degenerative joint disease affecting 81.4 million people in the USA, Japan and the five key European markets (UK, Germany, Italy, France and Spain) - according to Datamonitor in 2009. This most common type of arthritis is a leading cause of long-term disability. Although OA is not preventable, the pain and disability that result from severe disease can be reduced through the use of both non-arthroplasty and arthroplasty solutions._x000D__x000D_The joint reconstruction sector has benefited from advances in surgical techniques, biomaterials and devices that have enabled patients to choose alternate orthopaedic procedures instead of painful surgical procedures, and thus be restored to a pain-free, high quality of life. This is now the case for the hip and knee implants market, but still not in the hand implant market in which the appearance of early hand OA reCOs an issue._x000D__x000D_Symptomatic hand OA affects 20% of people over 55 years of age according to the EULAR and 1 in 12 older US adults (Source: American College of Rheumatology). Moreover, it is associated with a loss of independence, which can be difficult for active workers in the event of early OA, and requiring more support in the community or admission to residential care, according to the European Commission._x000D__x000D_What is at stake is to develop specific tools designed to prevent and postpone the onset of early incapacitating hand OA. Solutions which are currently available (anchor, synthetic ligament, screw, arthrodesis) do not provide satisfactory prevention of early OA. _x000D_Hand surgeons reCO much in demand for innovations in the areas of fixation devices such as bone plates and screws (specially new devices with enhanced mechanical properties and/or anisotropic behaviour), or coatings for optimizing implant performance, functionality and biocompatibility, so as to provide better treatments to pathologies of the hand and delaying the occurrence of OA._x000D__x000D_In particular, scapholunate instability, which occurs in about 1 out of 4 breaks of the distal extremity of the radius (source: ATIH), reCOs an unsolved problem. It results from the break of the scapholunate ligament involving osteoarticular injury and cartilaginous harm. Victims are for the most part young adults, who have had a significant fall with hyperextension of the wrist while exerting themselves in some way. As the pain often subsides after a while, the injury is usually neglected and treated as a sprain. Patients will then inevitably suffer from wrist pain until it becomes a premature and incapacitating hand OA._x000D__x000D_Research on scapholunate instability has not yet defined the appropriate management of the pathology, ensuring that patients regain their former higher quality of life. There is a real need for alternative solutions to cope with scapholunate instability and to significantly delay the progression of OA._x000D__x000D_In this context, the French R&D performing small and medium enterprise (SME) BIOTECH INTERNATIONAL (BI), a leading manufacturer of devices for extremities surgery asked RONDOL (RON), an English R&D performing SME provider of plastic processing equipment suitable for Micro/Nano Applications (mixing, extrusion, injection and compression moulding), to work on the introduction of specific biomaterials technologies with a view to developing a new reinforcement and stabilisation implant for small hand joints in a project called STABILIMP. _x000D_Since PEEK has already shown remarkable properties and provided solutions to unmet and complex medical needs (e.g. in the field of cardiac valves), the Ps intend to exploit the potential opportunities of PEEK in the field of precision orthopaedic surgery._x000D__x000D_Hence the goal of the STABILIMP project is to develop an implant made entirely of PEEK, designed to fit to the physiology of the tissues and to avoid cartilaginous wear (which is the cause of OA). The implant will play the part of stake in the event that the healing of the ligament is still possible; or as stabilizer. Consequently the onset of early OA is expected to be delayed for several years. It will also provide clinical benefits compared to existing techniques (shorter hospital stays, faster operations and rehabilitation times, improvement in the patients’ quality of life) and a reduction in healthcare costs in the long run._x000D__x000D_Among possible applications, the Ps have chosen to work on the scapholunate joint because it is one of the most complex and representative cases of joint reconstruction. The completion of the 24-month workprogramme will provide the first homogenous treatment of this pathology and pave the way for further adaptations to other small joints (finger, hand, foot, ankle, elbow, shoulder)._x000D__x000D_Moreover, in order to upgrade the final product and to speed up the access to the US market, the Mayo Clinic (Rochester, MN) will undertake the pre-clinical evaluation phase. The project will thus benefit from strong base._x000D_
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Acronym
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STABILIMP
(Reference Number: 6003)
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Duration
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01/03/2011 - 28/02/2013
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Project Topic
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Development of a new ligament reinforcement implant and/or stabilization implant made of polyetheretherketone (PEEK) with a dedicated design sensitive to the physiology of the wrist and designed to prevent early cartilage wear and significantly delay the onset of incapacitating osteoarthritis.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 5
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Project partner
