The LONESTAR Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The LONESTAR Cervical Stand Alone System is used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the LONESTAR Cervical Stand Alone System in the cervical spine.
The LONESTAR Cervical Stand Alone System, as with other orthopedic implants, is contraindicated for use in patients:
- With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
- With rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation.
- With conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
- With known or suspected metal allergies.
- With prior fusion at the level to be treated.