Spinal Cord Injuries Clinical Trial
Official title:
Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.
Safety Issues:
Safety issues need to be watched are: occurrence of known and unknown undesirable
incidences, moving up injury levels, loss of previously preserved neurological functions,
vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur,
patients will be consulted to determine whether treatments will be continued.
Adverse events:
Adverse events may occur during the trail and these events will be recorded. The severity of
the events and their relationship to the experimental therapy will be determined, documented
and reported to the Data Monitoring and Safety Committee who will determine how these events
will be handled if they occur.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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