Instructions for Use
for Granules or Putty
TriPore advanced synthetic bone graft consists of pure (100%) synthetic hydroxyapatite, HA, and is supplied in a delivery applicator. The delivery applicator is to facilitate impregnation of TriPore granules with bone marrow aspirate (BMA) or blood if required. After impregnation the mixture can be delivered directly into the defect site.
TriPore with delivery applicator is available in the following configurations:
|| Pack or Size
TriPore with delivery applicator is supplied in a sterile sealed pouch.
DO NOT USE product if the sterile pouch is broken or has been opened.
The medical professional is responsible for choosing the most appropriate granule size.
The patient’s bone marrow aspirate (BMA) or blood can be mixed with granules in the syringe before implantation (see instructions for use). The risks associated with the use of TriPore are exactly the same as those for any HA.
TriPore with delivery applicator is supplied in a sterile state. Only open the sterile pouch in a clinical environment.
TriPore with delivery applicator cannot be re-sterilised.
Instructions for use
These instructions are guidelines, and are 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. The procedure for use is as follows:
If BMA is used, the following quantities are suggested:
TriPore 8cc: 8cc BMA/Blood
TriPore 12cc: 12cc BMA/Blood
Or until the vent holes flood with excess BMA
Step 1: Remove the protective cap from the delivery applicator and discard into clinical waste. Do not open the transparent screw cap.
Step 2: Connect the autologous blood/BMA filled syringe to the connector of the screw cap
Step 3: Gradually push the fluid into delivery applicator until it reaches the plunger or floods the cap vent holes
Step 4: Place the delivery applicator into a sterile kidney tray and allow the granules to be loosely bound by coagulation for 20 minutes.
Step 5: Remove the screw cap from delivery applicator and discard it into the clinical waste.
Step 6: Push the mixture out of the barrel onto the defect site.
Step 7: Using fingers, gently work the saturated TriPore HA granules into the defect to fill the spaces and irregularities.
Indication for use
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.
The syringe and any opened, unused or partly used TriPore granules must be disposed in clinical waste.
Orthogem Ltd, BioCity, Pennyfoot Street, Nottingham, NG1 1GF, United Kingdom