ABOUT OSSDSIGN/GENERAL QUESTIONS
- Who are OssDsign?
OssDsign is an innovator, designer and manufacturer of implants and material technology for bone regeneration. We are surgeons, scientists and engineers - committed to improving outcomes in cranioplasty and facial reconstructive surgery.
- What are the outcomes and clinical results observed in using OSSDSIGN® Cranial PSI?
Clinical experiences with OSSDSIGN® Cranial PSI have shown low rates of post-operative complications. Kihlström et al. explored the clinical outcome of patients treated with OSSDSIGN Cranial PSI at a median follow-up period of 25 months. The results demonstrate that OSSDSIGN Cranial PSI provide positive clinical outcomes such as low explantation rate due to early post-op infections. Additionally, proof of concept demonstrate that the implant promotes bone regeneration and osseointegration.
- Where are the implants manufactured?
OssDsign has in-house manufacturing facility in Uppsala, Sweden.
- What does the ceramic material consist of?
The OSSDSIGN® material is a blend of Monetite, ß-tri calcium phosphate and ß-calcium pyrophosphate.
- How chemically stable is the material composition?
When implanted, the OSSDSIGN material is subject to the process of coupled bone formation. This process may vary between individuals due to differences in metabolic activity.
- Does the implant produce image artifacts in MR?
The implant is MR Conditional. Please see the full Instructions for Use for further information.
- Are the OSSDSIGN® products as mechanically strong as other products on the market?
An OSSDSIGN® Cranial implant can absorb almost twice the energy of a naked titanium mesh for a total deformation of 10 mm as shown in Kihlström et al. 2018. The ceramic tiles of OSSDSIGN® Cranial are connected by a titanium skeleton. The titanium component between the tiles is slightly thinner than the remainder of the main skeleton to provide local deformation zones, independent of the ceramic tile. If the implant withstands an external load, the deformation zones will absorb a large part of the load. These zones provide local flexibility, further shielding the ceramic tiles from damage.
USE OF OSSDSIGN® CRANIAL
- What are the storage conditions?
Store between 40-93°F (4-34°C)
- How is the implant sterilized and what is the shelf-life?
OSSDSIGN® Cranial PSI is delivered sterile and is confirmed to remain sterile for one year from date of manufacture. The sterilization method used by OssDsign is steam sterilization (20 minutes, 121°C).
- Can hospitals re-sterilize the implant, e.g. during surgery?
No, the implants should not be re-sterilized.
- How is the implant fixated?
The implant is attached to surrounding bone using tapered (counter-sunk) titanium screws inserted into the fixation arms. The fixation arms can be slightly bent for optimized fixation. No drilling or modification is required. More information on the surgical procedure can be found in the Instructions For Use.
- Can the implant be soaked before implantation?
Yes, however there is no need to soak OSSDSIGN® Cranial implants before implantation.
- Can I use locally administrated antibiotics together with the implant?
We are aware, that in certain patients thought to be at high risk of surgical site infections, Karolinska University Hospital have perioperatively soaked implants in sterile NaCl solution with added Gentamycin.
- Are there any specific considerations regarding wound closure and suturing?
A surgical incision directly above the implant increases the risk of wound dehiscence and subsequent infection and should be avoided if possible. If this approach can not be avoided, the use of vertical mattress suturing technique is recommended. https://www.youtube.com/watch?v=824FhFUJ6wc
- How can I order OSSDSIGN Cranial PSI?
To order an OSSDSIGN Cranial implant you need an account in OssDsign’s Customer Communication Platform (CCP). CCP is based on a technology platform that ensures secure data handling and storage. Registered customers can manage their order requests and communicate with our Customer Service and Design Engineers in a secure and easy way.
Contact firstname.lastname@example.org or your local OssDsign representative and we will help you get started.
- What are the requirements for the CT scan before placing the order?
CT scanning guidelines are available for download at our order page. Please contact us for more information.
- Can other types of images be used, e.g. MR?
No, CT according to scanning guidelines is currently the only option.
- What happens after an order request has been placed?
A price quote and a proposed implant design is sent to the ordering surgeon no later than two working days after the order and CT documentation have been received at OssDsign.
- How is the implant delivered?
The implants are delivered in a sterile packaging together with an instructive photo of the specific case.
- When can I expect delivery?
The implant is shipped from OssDsign’s facilities in Sweden 4 weeks after the digital design proposal and quote is approved by the customer.