SURGICAL TECHNIQUE. Compression screw FOREFOOT SOLUTIONS

Transcription

1 SURGICAL TECHNIQUE Compression screw FOREFOOT SOLUTIONS

2 SCARF OSTEOTOMY The Scarf osteotomy consists of a horizontal cut and two transversal cuts of the first metatarsal, allowing for a broad range of angular corrections. 1 APPORT SANGUIN BLOOD SUPPLY THE DIFFERENT CUTS First, a medial capsulotomy and a lateral release is performed (1). An inter-articular or inter-metatarsal approach is advised. The lateral sesamoid bone is dissected free by making a longitudinal incision between the lateral sesamoid and the lateral suspensory collateral ligament. This incision is extended anteriorly and the adductor hallucis is released from its phalangeal insertion. This way, after lateral displacement of the metatarsal fragment, the sesamoids will be placed under the metatarsal head (2). 2 The exostosectomy should be as minimal as possible. The longitudinal resection is performed in alignment of the medial aspect of the metatarsal shaft. The proximal midplantar dissection provides a quasi complete exposure of the midplantar margin and the plantar surface. This view is essential for the realization of the Scarf osteotomy. The longitudinal cut is performed parallel to the medial border as well as to the plantar surface (3). 3 The transversal cuts are chevron like cuts (45 angle with the longitudinal cut), which are perpendicular to the second metatarsal (slightly backwards) (4 & 5). The dorsal aspect of the distal transversal cut should be 5 mm proximal to the cartilage. The proximal transversal cut is realized at 10 mm distance from the cuneo metatarsal joint (6). DISPLACEMENT POSSIBILITIES The scarf allows: - Medial and lateral translations (7). - The P.A.S.A. or D.M.A.A. correction (8). - The lowering of the metatarsal head (9). - Elevation of the metatarsal head (10). - Shortening of the first metatarsal. - Lengthening of the first metatarsal (11) BOLD SURGICAL TECHNIQUE

3 Extern Intern P.A.S.A. correction DISPLACEMENT AND DRILLING The stabilization of the bone fragments is accomplished with a specific bone clamp. The clamp is designed to allow compression with variable lateral displacement (12) The clamp can remain in position while the 1mm K-wires are positioned (13). The positioning of the K-wires should be performed while taking into consideration the following : - The proximal K-wire should enter the dorsal fragment from medio dorsal to latero plantar. This way, the lateral sagittal beam is respected. - The distal K-wire (less oblique than the proximal one), is positioned so that it enters at the midsection of the dorsal fragment in order to transfix the plantarfragment dorso-plantarly (bi-cortical) or obliquely (mono cortical fixation) (14). 11 In order to prepare the drill holes for the screw setting, a specific «2 in 1» drill is used. This cannulated drill is used with the K-wires remaining in place. The distal part of the drill (2.2 mm diameter) is adapted to the body of the screw whereas the proximal part of the drill (3.0 mm diameter) is designed specially to countersink the head. The total length of the drill (18 mm) allows an overall use of the drill in most of the metatarsals (15). BOLD SURGICAL TECHNIQUE 3

4 SCREWS SETTING The surgeon will use the drill in order to prepare the two holes (16). Before drilling, once the K-wires are positioned, the length of the screws is measured by using the cannulated measurer screwdriver. The cannulated measurer screwdriver can be applied so that immediate reading of the length to implant can be done. As the screw is implanted dorso plantarly in order to achieve a bicortical compression, 2 mm will be added to the measured length. In the event of monocortical (oblique fixation in the metatarsal head) fixation, 2 mm will be deducted in order to avoid penetration into the cartilage (17). 16 Once the drill holes are performed, the BOLD screws are implanted with the measurer cannulated BOLD hex screwdriver of 2.5 mm (18). 17 FINALIZATION In order to avoid soft-tissue interference, care should be taken to countersink completely the screw head (19). Finally, the medial «bone-eminence», created due to the displacement of the bone fragments, is resected (20) BOLD SURGICAL TECHNIQUE

5 1 BLOOD SUPPLY 2 CHEVRON OSTEOTOMY The Austin/Chevron osteotomy is a V-type distal osteotomy of the first metatarsal. This osteotomy is performed in order to treat moderate hallux valgus deformities. PRINCIPLES OF THE AUSTIN OSTEOTOMY Correction : 1 mm = 1 Maximum : 1/2 width M1 The plantar cut is performed at a 60 angle towards the metatarsal base, with the center of the M1 head to be considered as the apex. The cut should be stopped back from the blood supply, in order to preserve the plantar vascularization (1). 3 The dorsal cut is identical to the dorsal transversal scarf cut. It is at a 45 angle towards the dorsal cortex, joining the center of the M1 head as the apex (2). The Chevron osteotomy allows a displacement which is equivalent to half the width of the metatarsal head. Should the displacement be more than 50% of the metatarsal width, the stability of the bone fragment, required for good bone healing, can be compromised (3). 4 MEASURING AND DRILLING Once the displacement is achieved, a 1 mm diameter, 7 cm long K-wire is inserted. Care should be taken not to pass through the cartilage. The K-wire will guide the screw. Due to atraumatic aspects of a K-wire, it can be withdrawn and replaced until perfect positioning is achieved (4). 5 The length of the screw is defined by the measurer cannulated screwdriver (5). The drilling in the bone is performed with the «2 in 1» drill. The dorsal cortex has to be completely countersunk by using the enlarged cutting edge tapered level of the «2 in 1» drill (6). 6 BOLD SURGICAL TECHNIQUE 5

6 SCREW SETTING The screw is placed and screwed with the measurer cannulated screwdriver (7). The head of the screw is completely embedded in the dorsal cortex in order to avoid soft tissue problems (8). The remaining edge, due to the lateral displacement of the head, is removed in order to avoid problems with shoe wear (9). This removed wedge can be used as a lateral graft to improve bone healing (10) BOLD SURGICAL TECHNIQUE

7 AKIN The Akin osteotomy is a medial closing wedge osteotomy performed at the level of the proximal phalangeal base. This will result in a variation of the proximal phalanx. The procedure is always performed with a definitive hallux valgus correction. 1 THE AKIN TECHNIQUE The proximal cut will be performed parallel to the metatarso - phalangeal joint line (1). The distal cut will be performed parallel to the nailbed of the great toe (2). The lateral cortex is kept intact. The medial wedge is removed (3). The closing technique is performed by surgical reduction. The BOLD screw is placed in order to achieve compression of the bone fragments (4) BOLD SURGICAL TECHNIQUE 7

8 8 BOLD SURGICAL TECHNIQUE FOREFOOT CONTAINER

9 BOLD SCREWS BOLD CLAMP DRILL DIAM 2.2 MM K-WIRE LENGTH 70 MM «2 IN 1» DRILL BOLD SCREWDRIVER BOLD SURGICAL TECHNIQUE 9

10 INSTRUCTIONS FOR USE Non-sterile IMPLANTS FOR FOOT SURGERY SINGLE USE In accordance with EEC directive 93/42 relative to medical devices, this product must be handled and/or implanted by WELL-TRAINED, QUALIFIED PERSONS, AWARE OF THESE DIRECTIONS FOR USE. 1 - Description of the medical devices: The implants - delivered non-sterile - are: - Compression screws existing in different diameters and lengths. - They are made nium alloy within the frame of the standard ISO and ASTM F Indications: The BOLD SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Fixation of small bone fragments, in long bones or small bones fractures. - Arthrodesis in hand or foot surgery - Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) 3 - Contraindications: The implant should not be used in a patient who has currently, or who has a history of: - Local or systemic acute or chronic inflammation; - Active infection or inflammation; - Suspected or documented metal allergy or intolerance. 4 - Warnings: Serious post-operative complications may occur from use of the implant in a patient who: - Lacks good general physical condition; - Has severe osteoporosis; - Demonstrates physiologic or anatomic anomalies ; - Has immunological responses, sensitization, or hypersensitivity to foreign materials; - Systemic or metabolic disorders; 5 - Precautions for use: Physician must determine if implant is appropriate for patients who have any of the following conditions: - Drug and/or alcohol and/or smoke addiction and/or abuse; - Infectious disease; - Malignancy; - Local bone tumors; - Systemic or metabolic disorders or replacement; - Compromised wound healing; - Obesity; - Demonstrated psychological instability, displayed a lack of understanding, inappropriate motivation, or attitude; - Unwillingness to accept the possibility of multiple surgeries for revision or replacement; - Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it; - Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation; Knowledge of surgical techniques, proper reduction, selection and placement of implants, and post-operative patient management are considerations essential to a successful outcome. Criteria for patient selection is the responsibility of the surgeon. Information contained within this document should be taken into consideration during the selection process. Recognition of the appropriate indications and contraindications and the selection of the proper surgical procedures and techniques determined to be best for the patient are the responsibility of the surgeon. Each surgeon must evaluate the appropriateness of the procedure and instruments used during the procedure based on his or her own training and experience. The surgeon should discuss with the patient prior to surgery possible risks, precautions, warnings, consequences, complications, and adverse reactions associated with the surgical procedure and implantation of the device. Each patient must be evaluated by the surgeon to determine the specific risk/benefit relationship in light of the patient s condition and the surgeon s practice, training, experience, and knowledge of the related medical literature. Complications with the use of compression screws have been reported in the medical literature. Any patient undergoing a surgical procedure is subject to intra-operative and post-operative complications. Each patient s tolerance to surgery, medication, and implantation of a foreign object may be different. Possible risks, adverse reactions, and complications associated with surgery and the use of the compression screws should be discussed with and understood by the patient prior to surgery. The implant is composed of titanium alloy materials; therefore, it is subject to possible reactions and complications, including those listed herein. The patient should not be led to unrealistic expectations as to the performance or results that the surgery and implant can provide. The patient should be informed that the life expectancy of the device is unpredictable once implanted, and that successful results cannot be guaranteed. IT IS THE RESPONSIBILITY OF THE SURGEON TO PROVIDE THE PATIENT WITH INFORMATION PRIOR TO SURGERY. Complications may include but are not limited to : -- Pain, discomfort, or abnormal sensations due to presence of the implant ; -- Bending, loosening, and/or breakage, which could make removal impracticable or difficult ; -- Risk of additional injury from post-operative trauma ; -- Migration of the implant position or implant material resulting in injury ; -- Bone loss due to stress shielding ; Side effects may include but are not limited to: -- Infections ; -- Hematoma ; -- Allergy ; -- Thrombosis ; -- Bone non union or delayed union. Adverse effects may necessitate re-operation, revision or removal surgery, arthrodesis of the involved joint, and /or amputation of the limb. Implant removal should be followed by adequate postoperative management to avoid fracture or re-fracture. Interference risks during medical imaging: MRI/SCANNER: ask the patient to systematically mention that he/she has undergone a surgical intervention. 6 - Instructions for reprocessing: This product is sold non-sterile. Check the integrity of the packaging and labeling before opening the packing. Remove all the products from their packaging prior to sterilization All products should be cleaned, decontaminated, and sterilized before use. Always immediately clean and decontaminate all devices that have been soiled. Repeated reprocessing has little effect on these products. Preparation: Double instruments (ex. Internal screwdriver and associated external screwdriver) should be separated prior to cleaning. Cleaning: Cleaning can be performed manually, automatically or ultrasonically in accordance with the specifications designated by the manufacturer of the hospital s equipment. Manual cleaning: Manual cleaning consists of using aldehyde free cleaners (neutral or alkaline), applied with a soft brush, taking special care to threaded parts and parts difficult to reach. Note: Certain solutions such as those containing bleach or formalin may damage the devices, and they must not be used. Use of metallic brushes or other abrasive products is also forbidden. Cleaning should be immediately followed by profusely rinsing with deionized water. Check that water flows out the cannulated parts. Automatic cleaning: Automatic cleaning is performed in a cleaning/disinfecting machine using neutral cleaners, with a cleaning cycle of 5 minutes minimum and a rinsing cycle of 3 minutes. Check the complete removal of visible dirt, especially in the cannulated parts. If necessary, repeat the full process or proceed to a manual cleaning. Disinfection: If an automatic cleaning is used, final rinsing at 95 C during 10 minutes can be performed. Drying: Drying temperature should not exceed 95 C. Controls, servicing and tests: No specific requirements. The implants are single use. They should therefore never be re-used. Packaging: No specific requirements. Sterilization: Newdeal s implants and instruments are recommended to be sterilized by the steam autoclaving procedure regularly used in the hospital. The following two methods have been validated by the manufacturer and can thus be used: Method: steam Method: steam Cycle: wrapped gravity Cycle: wrapped gravity Temperature: 132 C Temperature: 134 C Exposure time: 45 minutes Exposure time: 18 minutes Other sterilization method and cycles may also be used. However, individuals or hospitals not using the recommended method are advised to validate the alternative method using appropriate laboratory techniques. EtO sterilization or cold sterilization techniques are not recommended. 7 - Use of the implant: The surgeon must use the instrumentations recommended in accordance with the operative technique available from the manufacturer. The medical device must be used in compliance with the use of the profession and the standard of art. Do not attempt a surgical procedure with faulty, damaged or suspect instruments or implants. Inspect all components preoperatively to assure utility. Alternate fixation methods should be available intraoperatively. Opening of the instruments set must be done according to aseptic condition. When handling the implants, avoid any contact with other material or tools which may damage the implant surface. Under no circumstances should the implant be modified. 8 - Re-use of the implants: Orthopedic implants already implanted must never be re-used. The company accepts no responsibility for such re-use. 9 - Re-sterilization of non implanted products: Re-sterilization is only allowed for non-implanted products. Such non-implanted products can be sterilized several times in the same conditions as those described above Preventative actions for the patient to avoid post-operative complications: - Avoid extreme position such as flexion-extension - Wear orthopaedic shoes according to the surgeon s prescription - Receive prompt medical attention for any infection that could occur, whether at the operated-member level or elsewhere in the body Storage: Store in dry place 12 - Liability: Newdeal shall not be liable for any incidental or consequential loss, damage, or expense, directly, or indirectly arising from the use of this product. Newdeal neither assumes nor authorizes any other person to assume for it any other or additional liability or responsibility in connection with this product. Newdeal intends that this device should be used only by physicians having received appropriate training in orthopedic surgery techniques. WARNING: Federal law (USA) restricts this device to sale by or on the order of a physician. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. INFORMATION: Should any information regarding the products or their uses be required, please contact your representative or distributor or directly contact the manufacturer. 10 BOLD SURGICAL TECHNIQUE

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12 Compression screw BOLD DIAM. 3.0MM CATALOG NUMBER DESCRIPTION ND LENGTH 10 mm ND LENGTH 12 mm ND LENGTH 14 mm ND LENGTH 16 mm ND LENGTH 18 mm ND LENGTH 20 mm ND LENGTH 22 mm ND LENGTH 24 mm ND LENGTH 26 mm ND LENGTH 28 mm ND LENGTH 30 mm ND LENGTH 32 mm ND LENGTH 34 mm ASSOCIATED INSTRUMENTS CATALOG NUMBER DESCRIPTION ND K-WIRE LENGTH 70 mm ND CANNULATED MEASURER SCREWDRIVER ND BOLD CLAMP ND CANNULATED DRILL DIAM. 2.2 mm ND «2 IN 1» DRILL LENGTH 18 mm CATALOG NUMBER OPTION DESCRIPTION ND «2 IN 1» DRILL LENGTH 07 mm ND «2 IN 1» DRILL LENGTH 28 mm ND «2 IN 1» DRILL NON CANULATED LENGTH 28 mm ND «2 IN 1» DRILL NON CANULATED LENGTH 18 mm ND «2 IN 1» DRILL NON CANULATED LENGTH 07 mm The products are manufactured and referenced within the frame of the standards in force. Implantation procedures are described in the surgical technique. Non-contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. WARNING: Federal law (USA) restricts this device to sale by or on the order of a physician. NS762 1/05 Printed in USA 2.5K Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ (Outside USA) (Fax) Newdeal and BOLD are registered trademarks of Integra LifeSciences Corporation. The Integra wave logo and Forefoot Solutions are trademarks of Integra LifeSciences Corporation Integra LifeSciences Corporation. All rights reserved.