Comparison of Actifuse ABX and Local Bone in Spinal Surgery
Stopped early · Phase 4
Conditions studied: Scoliosis, Kyphosis, Lordosis
In brief
This study is being done to compare people who had a standard of care spinal fusion using part of their local bone graft (a small amount of bone from the region of the spine where the fusion is occurring) to correct an adult spinal deformity and people who will have a standard of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft substitute) and a local bone graft (a small amount of bone from the region of the spine where the fusion is occurring). This study will compare the outcomes of both groups to help the Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that Actifuse ABX® will be as good if not better than just a local bone graft.
Key facts
- Study ID
- NCT01852747
- Run by
- Ohio State University
- People needed
- 14
- Starts
- 2013-03-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-04-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient aged 18 to 80
- Patient received primary diagnosis of adult spinal deformity (with fusion of >2 levels)
- Patient is a candidate for multi-level posterior lumbar fusion
- Patients that do not meet any of the exclusion criteria
You may not qualify if…
- Non-English speaker
- Current Smoker
- Prisoner
- Patient with any of the following:
- Severe degenerative disease Inflammatory bone disease (e.g. osteomyelitis) Metabolic bone disease Radiation bone therapy Existing acute or chronic infections Abnormal calcium metabolism Hypocalcaemia Severe vascular or neurological disease Cardiovascular disease precluding elective surgery Uncontrolled diabetes Severely impaired renal function Documented renal disease Malignant tumors Pregnant or nursing
Where it is running
- The Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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