OPRA Implant System. Product Catalogue Prosthetic Products

Transcription

1 OPRA Implant System Product Catalogue Prosthetic Products

2 Our vision is to continuously lead the improvement of medical devices using evidence based development. Integrum has since the start in 1998 been helping individuals with amputations towards an improved quality of life. A thorough experience in osseointegration has generated a system for bone-anchored prostheses a beneficial alternative to the traditionally used socket prosthesis. Integrum is world leading in this area, with patients from all parts of the world treated in 12 clinical centres. Performing continous research and development, Integrum aims at providing safe medical devices, supporting a more active life-style and improving quality of life. In order to meet individual needs, custom-made solutions are developed in close collaboration with scientists and clinicians. Integrum AB Krokslätts Fabriker 50 SE Mölndal, Sweden Phone: +46 (0) Fax: +46 (0) info@integrum.se Copyright Integrum AB 2

3 Table of contents OPRA IMPLANT SYSTEM 4 General Information PLATFORM STRUCTURE DESCRIPTION 6 LOWER EXTREMITY 8 Transfemoral or transtibial level Soft Tissue Support Extension Plate Spare Parts UPPER EXTREMITY 10 Digit Prosthetic Components Transradial level Transhumeral level Doc.No: May

4 OPRA Implant System The OPRA Implant System for bone-anchored prostheses serves as a stable and direct connection to the amputation prosthesis. OPRA is available for the following amputation levels: Transfemoral (above-knee) amputations Transtibial (below-knee) amputations Transhumeral (above-elbow) amputations Transradial (below-elbow) amputations Finger / thumb amputations Surgical procedure The system consists of an anchoring element (the Fixture) and a skin penetrating connection (the Abutment), secured with a screw (the Abutment Screw). The implant components are surgically inserted into the bone of the amputation stump in two separate surgical sessions and connected to the external prosthesis through a connection device. S1 components Fixture Central Screw (for large Fixture sizes) Healing components S2 components Abutment Abutment Screw Fixture Fixture Central Screw Healing Cylinder Abutment Abutment Screw Cylinder Screw Graft Screw Bone Skin Result after S1 surgery Result after S2 surgery Prosthetics The Abutment is connected to the external prosthesis through different connection devices depending on the amputation level. The prosthetic components include attachment, alignment and load control functions in order to protect the implant from accidental loads. More information can be found in the product catalogue for prosthetic components. 4

5 Benefits of OPRA Benefits of the OPRA Implant System compared to socket prostheses: Increased range of motion Eliminates pressure, sores and pain caused by the socket Stable attachment Easy attachment and detachment Improved osseoperception (sensory feedback) Can be worn all day, every day No socket adjustments required Suitable for short amputation stumps Better walking ability (lower limb amputations) Improved sitting comfort (above-knee amputations) all contributing to an improved quality of life 1. References 1) Brånemark, R., Berlin, Ö., Hagberg, K., Bergh, P., Gunterberg, B., & Rydevik, B. (2014). A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation A prospective study of 51 patients. Bone & Joint Journal, 96(1), ) Lundberg, M., Hagberg, K., & Bullington, J. (2011). My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb.prosthetics and orthotics international, 35(2), ) Haggstrom, Eva E., Elisabeth Hansson, & Kerstin Hagberg (2013). "Comparison of prosthetic costs and service between osseointegrated and conventional suspended transfemoral prostheses." Prosthetics and orthotics international,37.(2), ) Hagberg, Kerstin, & R. Brånemark (2001). "Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems."prosthetics and orthotics international 25.(3),

6 Lower Extremity Transfemoral or transtibial level Ref No Product Comment 1288 OPRA Axor II Femur 1455 Axor TC Centric Tibia 1458 Axor TC Excentric Tibia IBK0003 OPRA Connector Training Femur/Tibia IBK0003 6

7 Lower Extremity Soft Tissue Support Ref No Product 1290 OPRA Soft Tissue Support Pylon II 0 IBK0041 OPRA Soft Tissue Support Pylon / IBK0041 IBK0042 IBK0043 OPRA Soft Tissue Support Plate small OPRA Soft Tissue Support Plate large 0 Used together with Axor II. 1 Used together with Rotasafe/Axor TC/Connector. IBK0042/IBK0043 Extension Plate Ref No Product 1165 Axor Extension Plate 5 mm 1166 Axor Extension Plate 10 mm 1167 Axor Extension Plate 20 mm 1165/1166/1167 Spare parts Ref No Product IBK0033 OPRA Connection set Connection Set Left 4 2 Spare part for Rotasafe and Axor TC 3 Tightening screw is positioned at the right 4 Tightening screw is positioned at the left IBK0033/1665 7

8 Upper Extremity Digit Prosthetic Components Ref No Product 1655 Digit Prosthetic Component Angulated 1656 Digit Prosthetic Component Straight Spare Parts Ref No Product 1713 Frame Screw Attachment Screw Spare part for Digit Prosthetic Component Angulated 2 Spare part for Digit Prosthetic Component Straight

9 Upper Extremity Transradial level For prosthetics on the transradial level, please contact Integrum for ordering and advice. Transhumeral level Ref No Product Comment 1652 Puck Used for all type of prosthesis 1651 Humerus Attachment Device Used for all type of prosthesis 1653 Alignment Device Used for cosmetic prosthesis 1654 Rotation safety device Used for cosmetic prosthesis 1671 Humerus Training Kit Used for training and rehabilitation

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12 Integrum AB Krokslätts Fabriker 50 SE Mölndal, Sweden Phone: +46 (0) Fax: +46 (0) Copyright Integrum AB Doc.No: May 2015