Instructions for Use
TriPore® Granules or Blocks
TriPore® is a 100% hydroxyapatite synthetic bone graft.
TriPore is presented in a sealed blister pack. This is a sterile seal. DO NOT USE TriPore if this blister is broken or opened. The bottle lid is not a sterile seal.
TriPore granules are to be used as provided and not altered in any way before use.
TriPore blocks may be shaped prior to use by wetting with sterile saline solution then using a sharp blade to shape or cut the blocks to the desired size/shape. TriPore blocks should be rinsed with sterile saline post shaping to remove debris created during cutting.
The medical professional is responsible for choosing the most appropriate granule size. As with other synthetic bone graft materials, granules may be mixed with bone marrow aspirate for containment. The risks associated with the use of TriPore are exactly the same as those for any HA.
TriPore is supplied in a sterile state. Only open the TriPore sterile blister in a clinical environment. TriPore cannot be re-sterilised.
Instructions for use
These instructions are guidelines, and in no way intended to modify or replace existing proven clinical procedures.
Bone grafting procedures can lead to highly variable results. Normal factors which are considered for bone grafting should be utilised for TriPore.
Any surgical procedure requiring bone-graft where the use of autograft would be precluded either due to the secondary effects of graft harvest (e.g. pain, disfigurement etc) or lack of autograft. This would include treatment of long bone fractures, particularly when there is significant bone loss; spinal fusion surgery in the postero-lateral gutter, posteriorly and in the interbody space; maxillo-facial surgery for reconstruction of the jaws or facial skeleton.
TriPore is designed to fill bone voids and act as a bone graft extender / expander in non-weight-bearing applications and if weight-bearing is anticipated the graft site will need to be protected by supplemental internal and/or external fixation.
There are no known side effects in using TriPore over and above such effects as can be found in general bone void filling. These, include, but are not limited to: infection of the soft tissue and/or bone (osteomyelitis); adverse tissue reaction; transient hypercalcemia; incomplete bone formation or lack of bone formation; delayed union/non-union; fracture of the bone void filler with or without particulate formation; device migration or extrusion; fracture of the newly formed bone
TriPore presents no implantation risks other than those normally associated with bone void fillers. These are listed in the paragraph called ‘Side effects’.
TriPore must only be used as indicated in these instructions. Conditions which exclude the use of TriPore include:
- Infected sites
- Existence of metabolic bone disorders that affect bone and/or wound healing
- Locations where the surgical site may be subjected to excessive impact or stress
- Fractures of the growth plate and segmental defects
- Where there is significant vascular restriction proximal to the graft site
- When general bone grafting is not advisable
Use of this device in skeletally immature patients has not been investigated.
Any opened, unused or partly used TriPore must be disposed in clinical waste.
||Orthogem Ltd, BioCity, Pennyfoot Street, Nottingham, NG1 1GF, United Kingdom