Indications
The Galaxy Fixation System is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups excepts newborns as required. The indications for use include:
- Open or closed fractures of the long bones
- Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures
- Infected and aseptic non‐unions
- Joint pathologies/injuries of upper and lower limb, such as:
- Proximal humeral fractures
- Intra-articular knee, ankle and wrist fractures
- Delayed treatment of dislocated and stiff elbows
- Chronic, persistent elbow joint instability
- Acute elbow joint instability after complex ligament injuries
- Unstable elbow fractures
- Additional elbow stabilization of post-operative unstable internal fixation
The Orthofix Galaxy Wrist External Fixator is intended for the following indications:
- Intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage
- Polytrauma
- Carpal dislocations
- Unreduced fractures following conservative treatment
- Bone-loss or other reconstructive procedures
- Infection
- The Shoulder Fixation System is intended to be used for proximal humeral fractures where two thirds of the methaphysis is intact
Contraindications
The Galaxy External Fixation System is contraindicated for:
- Patients with mental or physiological conditions who are unwilling or incapable of following postoperative care instructions
- Patients with severe osteoporosis
- Patients with severe, poorly controlled diabetes mellitus
- Patients with compromised vascularity
- Patients with previous infections
- Patients with malignancy in the fracture area
- Patients with neuromuscular deficit or any other conditions that could influence the healing process
- Patients who are HIV positive
- Patients with foreign body sensitivity where material sensitivity is suspected, tests should be made prior to implanting