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Product Description

The ISKD^® is a unique concept in limb reconstruction that has greatly improved the potential to lengthen limbs. The ISKD combines the advantages of intramedullary stabilization with the mechanics of external distraction in one device, offering the ability to lengthen up to 8 cm with a simple nailing technique.

Implanted after osteotomy, the ISKD lengthens gradually in response to normal movements of the limb. The ISKD is designed to distract when rotation occurs at the osteotomy site.Because the ISKD is completely internal, the potential risk of infection is reduced compared to lengthening procedures that require external pins or wires. In addition, there is no scarring from pins moving through the soft tissues.

The ISKD is designed to lengthen for a predetermined distance and then stop. A range of sizes are available to offer lengthening for most patients.

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Indication

The ISKD is indicated for limb lengthening of the tibia and femur and is used for:

• Post-traumatic lengthening
• Lengthening following acute shortening
• Lengthening in cases of congenital shortening
• As an alternative to closed shortening

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Physician Benefits

• Lengthening with a simple nailing technique
• Gradual callus distraction provides a natural lengthening process
• Lengthening in cases of congenital shortening
• Mechanical alignment and stability is maintained during lengthening and throughout consolidation

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Physician Support Materials

Brochures:

• ISKD Brochure
• Brochure: Patient Education
• Brochure: ISKD Monitor Manual - Patients
• Brochure: ISKD Monitor Manual - Physicians
• Brochure: Stretching Exercises
• Brochure: Patient Exercises (Courtesy of Dror Paley, MD, FRCSC, Illustrations courtesy of the Rubin Institute for Advanced Orthopaedics)
• Operative Technique*: ISKD Tibial Surgical Technique
• Operative Technique*: ISKD Femoral Surgical Technique

Videos:

• Video - Dr. Paley: Limb Lengthening Video (large download)
• How the ISKD Works
• Surgical Overview
• How the ISKD Monitor Works
• Bone Lengthening Process

*Proper surgical procedure is the responsibility of the medical professional. Operative techniques are furnished as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based on his or her personal medical credentials and experience. Please refer the the "Instructions for Use" supplied with the product for specific information on indications for use, contraindications, warnings, precautions, adverse reaction information and sterilization.

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Clinical References:

• The Intramedullary Skeletal Kinetic Distractor (ISKD): First Clinical Results of a New Intramedullary Nail for Lengthening of the Femur and Tibia. Full Text Article (PDF 5KB)
• Improved comfort in lower limb lengthening with the intramedullary skeletal kinetic distractor . Principles and preliminary clinical experiences. Full Text Article (PDF 314KB)

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Patient Benefits

• Internal device reduces psychological and social stress
• Less painful than other lengthening methods
• Minimal scarring
• No risk of pin-tract infections
• Hand held monitor allows patients to follow their lengthening process

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Patient Support Materials

Brochures:

• ISKD Brochure
• Brochure: Patient Education
• Brochure: ISKD Patient Monitor Manual
• Brochure: Stretching Exercises
• Brochure: Patient Exercises (Courtesy of Dror Paley, MD, FRCSC, Illustrations courtesy of the Rubin Institute for Advanced Orthopaedics)

Videos:

• Video - Dr. Paley: Limb Lengthening Video (large download)
• How the ISKD Works
• How the ISKD Monitor Works
• Bone Lengthening Process

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Web Resources

1. www.ISKD.com
2. www.limblengthening.com
3. www.limblength.com
4. www.llrs.org
5. www.lengthening.us (Dror Paley, MD)
6. www.FractureCareCenter.com (Dean Cole, MD)

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Contraindications

1. Cases in which there is an active infection or irregular bone diameter that would prevent the insertion of the ISKD Internal Limb Lengthener.
2. Cases in which the ISKD Internal Limb Lengthener would cross joint spaces or open epiphyseal growth plates such as in skeletally immature patients.
3. Cases in which there is an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity.
4. Patients with poor bone quality or metabolic bone disorders such as severe osteopenia, osteoporosis, osteomyelitis, poorly controlled diabetes mellitus, Paget's disease, etc.
5. Patients with malignancy or tumor of the bone to be lengthened.
6. Patients unwilling or incapable of following postoperative care instructions.
7. Cases requiring the use of magnetic resonance imaging (i.e., MRI) while the ISKD Internal Limb Lengthener is implanted. Do not subject patients implanted with an ISKD Internal Limb Lengthener to MRI.

WARNINGS

1. The ISKD Internal Limb Lengthener and Locking Screw assembly cannot withstand the stresses of full weight bearing. The patient should utilize external support and/or restrict activities until consolidation occurs.
2. Use of the ISKD System in patients with cardiac pacemakers is not recommended due to the presence of the magnet sealed inside the ISKD Internal Limb Lengthener. It is possible that the limb implanted with an ISKD Lengthener could come in close proximity to the implanted pacemaker.
3. Use of the ISKD System in patients with gross obesity is not recommended.
4. The ISKD System may not be appropriate for patients with poly-trauma.
5. Use of the ISKD System in patients with an active nonunion of the tibia or femur is not recommended.
6. Smoking, chronic steroid use and the use of other anti-inflammatory drugs have been determined to affect bone healing and could potentially have an adverse effect on the bone regenerate during the lengthening process.
7. The ISKD Lengthener and Locking Screws must not be reused. Reuse could result in device malfunction necessitating surgical re-intervention to remove or replace the Lengthener or Locking Screws.
   

PRECAUTIONS

1. Examine all ISKD System components carefully PRIOR TO USE to assure proper working condition. If you believe an ISKD System component to be faulty, damaged or suspect DO NOT USE.
2. Once implanted, the ISKD Internal Limb Lengthener will not stop distracting until it reaches the length pre-determined by the physician. Refer to the appropriate Operative Technique for instructions regarding X-ray technique, limb measurement and proper ISKD implant selection.
3. To ensure proper device functioning, ream to a width of 2.0 mm greater than the Lengthener diameter. Failure to do so can result in device malfunction necessitating surgical re-intervention to remove or replace the Lengthener or Locking Screws.
4. Do not vigorously hammer device in place. Doing so can result in device malfunction necessitating surgical re-intervention to remove or replace the Lengthener or Locking Screws.
5. It is important that the ISKD Lengthener does not fit too tightly in the intramedullary canal so as to permit the rotational movement required for function of the lengthening mechanism. Failure to do so can result in device malfunction necessitating surgical re-intervention to remove or replace the Lengthener or Locking Screws.
   
6. It is essential that proper operative technique be followed for ISKD implantation. Refer to the appropriate ISKD Operative Technique Guide.

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Footnotes

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Refer to the instructions for use supplied with product for specific information on indications for use, contraindications, warnings, precautions, adverse reaction information, and sterilization.

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