IDET™
INTRADISCAL ELECTROTHERMAL™ Therapy
Potential Risks
Potential complications related to the IDET◊ procedure include the following:
- Pain: Persistent and sometimes increased low back pain is expected during the 1st week after the IDET◊ procedure.
- Nerve injury: As in discography, there is always some risk of nerve injury. Keeping the patient awake and responsive under partial anesthesia helps prevent this problem.
- Catheter breakage: Excessive manipulation of the flexible catheter can cause it to kink and break off in the disc. The catheter material is inert, so in most cases
A 2001 review of 1,675 IDET◊ procedures & 35,000 FDA medical device reports found a low rate of complications
The most comprehensive profile of complications reported during and after the IDET◊ procedure was presented by Saal et al at the 2001 meeting of the North American Spine Society. The authors reviewed 1,675 procedures performed at five different spine centers and data on 35,000 SPINECATH◊ catheters from FDA medical device reports. Major findings include:
- The rate of serious complications was only 0.7% (12/1,675), and all were transient. Six nerve root injuries (<0.4%) — 5 occurred at the time of disc puncture, and all resolved without subsequent discitis.
- Six cases of herniation of the treated disc (<0.41%) 2-12 months post-IDET◊ — 4 resolved without surgery; 2 required surgical disc excision.
- Nineteen cases of catheter breakage (1.1%) due to excessive manipulation by the operator — in 16 of those cases, the catheter tip was left in the disc with no subsequent complications, and no case was associated with any patient morbidity.
- Eight cases of superficial skin burn (0.5%) at the needle puncture site — these can only be described as operator error.
The overall picture that emerges from this study is one of a minimally invasive procedure with few potentially serious risks and an impressive record of safe use in actual practice. The prospect for good outcomes also depends on appropriate pre- and postprocedural patient care.