Instructions for Use

See instructions for use for full prescribing information

These instructions are intended as guidelines for the use of Trel-X™ as a part of established surgical techniques. They are not intended to replace or change standard procedures for treatment of bone defects involving bone grafting and intemal fixation. Procedures involving bone grafting can experience highly variable results. Factors to be considered in selecting the bone grafting material and the surgical technique to be utilized are as follows:

• Age of the patient
• Quality of the patient's bone
• Location of the defect
• Anticipated loading conditions
• Proximity of the graft to a suitable blood supply
• Ability to achieve direct apposition of the graft to viable host bone
• Presence/addition of autogenous bone or bone marrow at the graft site
• Elimination of gaps in the graft sites' ability to suitably stabilize the graft site
• Complete coverage of the graft material to prevent migration

For best results, extreme care should be exercised to assure the correct graft material is selected for the intended application.

To Open Putty

• Peel open outer package
• Using aseptic technique, transfer contents to a sterile field
• Peel open inner package and remove spatula and vial
• Twist off vial lid and remove putty using small spatula or other hand instrument
• Discard any unused portion

To Open Gel

• Peel open outer package
• Using aseptic technique, transfer contents to a sterile field
• Peel open inner package and remove syringe
• Remove protective cap from syringe tip
• Apply pressure to the plunger to extrude gel
• Discard any unused portion

Pre-Operative Preparation

Aseptic techniques must be maintained to minimize the risk of post-operative complications. The amount needed is based on the type of procedure and size of the defect being treated. When Trel-X™ is being mixed with autograft, a ratio of 1: 1 should be used. Trel-X™ does not require rehydration prior to use.

Radiographic evaluation of the defect site is essential to accurately assess the extent of the defect and to aid in the selection and placement of Trel-X™ and fixation devices.

Surgical Procedure Notes: Trel-X™ does not possess sufficient mechanical strength to support the reduction of a graft site prior to tissue in-growth. Therefore, anatomical reduction and rigid fixation, in all planes, should be obtained independent of Trel-X™.

For best results, Trel-X™ must fill the defect and contact as much viable bone as possible.

Trel-X™ must not be used to repair bone defects where complete soft tissue coverage cannot be achieved.

Post-Operative Care

Post-operative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Standard post-operative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices. The patient should be cautioned against early weight bearing and premature ambulation which could lead to loosening and/or failure of the fixators or loss of reduction. The length of time a defect should remain in a reduced state of loading is determined by the complexity of the defect site and the overall physical condition of the patient. Hardware should not be removed until the defect is healed.