- What is OsteoMax?
- What are the top four indications for OsteoMax?
- What is the OsteoMax Shelf Life?
- What are the OsteoMax Storage Conditions?
- Is OsteoMax weight bearing?
- Can OsteoMaxP or K accept screws or other hardware?
- Can OsteoMaxP or K be used for iliac crest backfill?
- Which OsteoMax product is used for what application?
- How long does it take for OsteoMaxP to fully set?
- How long does it take for OsteoMaxK to fully set?
- What happens if OsteoMaxK or P get wet?
- Why is Resorption Rate an important consideration with bone void fillers?
- Is OsteoMax appropriate for patients who are allergic to sulfonamides?
What is OsteoMax?
OsteoMax is an osteoconductive bone void filler. OsteoMax is a tri-phasic, 100% resorbable and 100% synthetic compound made of:
- Hydroxyapatite
- TriCalcium Phosphate
- Calcium Sulfate The Tri-Phasic formula allows for a controlled resporption profile
- Engineered to resorb in stages and provides a supply of bone-building minerals for an extended period of time.
- Stays at the site long enough to allow time for natural bone remodeling.
- Biocompatible Calcium salt with nanocrystalline hydroxyapatite. Single Phase products typically offer less flexibility in their resporption behavior.
What are the top four indications for OsteoMax?
- Distal Radius Fractures (wrist fractures)
- Tibial Plateau (Metaphyseal defect in a closed space)
- Calcaneous defects
- Bone cyst voids or benign tumor voids
What is the OsteoMax Shelf Life?
All OsteoMax products (granules, blocks and powder for putty) have a shelf life of three years. However, the sterile water included with the OsteoMaxK (putty injection kit) currently has a shelf life of one year. Take care that the OsteoMaxK containers are not left in extreme heat or cold, as the sterile water vials can rupture due to extreme temperatures.
What are the OsteoMax Storage Conditions?
Store in a dry place at room temperature. Optimal Storage Conditions: 15 - 30ºC (59-86ºF), <70% relative humidity. DO NOT FREEZE OR ALLOW PACKAGE TO GO BELOW FREEZING TEMPERATURE (0ºC/32ºF). On the package, the temperature range is listed as between 0ºC (32ºF) - 70ºC (140ºF).
Is OsteoMax weight bearing?
OsteoMax is not a weight bearing product.
Can OsteoMaxP or K accept screws or other hardware?
OsteoMax is NOT suitable for drilling.
Can OsteoMaxP or K be used for iliac crest backfill?
NO. This is contraindicated.
Which OsteoMax product is used for what application?
Ultimately, it is the surgeon’s decision which product s/he would like to use. However, there are some guidelines to assist in the decision-making process:
| Choosing the Appropriate OsteoMax Formulation | |
|---|---|
| High risk of infection due to soft tissue damage | Granules |
| Defect size <10cc | Putty/Injection Kit |
| Defect size <10cc | Granules |
| Defect geometry well-defined | Block |
| Patient requires longer to heal due to physiological reasons | Granules |
| Surgeon wants rapid resorption (4 months) | Putty/Injection Kit |
| Surgeon wants longer resorption (more than 4 months) | Granules |
| Surgeon wants minimally invasive delivery system | Injection Kit |
How long does it take for OsteoMaxP to fully set?
Five minutes
How long does it take for OsteoMaxK to fully set?
Seven minutes
What happens if OsteoMaxK or P get wet?
After the initial one minute of prep, OsteoMax will set in an aqueous or bloody environment. For example, the putty may be placed into the void for the final two minutes of set time. The Injectable sets completely in the void. However, care should be taken to avoid large amounts of liquid until the set process is complete.
Why is Resorption Rate an important consideration with bone void fillers?
The resorption rate is important because of the variability in cases. Here are a few examples:
- Is the person high-risk for nonunion? If so, then healing will be slower and remodeling should take place over an extended time.
- Where is the fracture located? Different fractures have different healing rates.
The bottom line is that the surgeon must evaluate what resorption rate is important to them and then make the decision based on their expert knowledge of the particular case.
Is OsteoMax appropriate for patients who are allergic to sulfonamides?
There is no risk of allergy from calcium sulfate. Calcium sulfate is a non-organic salt, a very small molecule with no antigenic properties. The molecule has no relationship to the sulfonamide molecule that causes allergies in some people. Thus, the use of OsteoMax in persons with sulfonamide allergies is permitted.
