Introducing the external link model for studying spine fixation and misalignment: current procedures, costs, and failure rates.

OBJECTIVE

This is the last article in a series of 3 articles introducing a new animal model, the external link model (ELM), that permits reversible, nontraumatic control of the cardinal biomechanical features of the subluxation: fixation and misalignment. A detailed description of current ELM procedures is presented and practical issues are reviewed such as expense (dollars and time) and construct failure rates during and after the surgical implant procedure.

METHOD: Descriptive report of current ELM procedures, refinements to the spinous attachment units (SAUs), and tabulation of costs and failure rates drawn from recent studies.

RESULTS

In contrast to the older, 1-piece stainless steel SAUs, new 3-piece titanium SAUs may be reimplanted many times without failure. Consequently, the cost per ELM ranges from $579 to $69, depending on whether the SAUs, links, and screws must be purchased or are already available for implanting. The SAU implant procedure requires between 0.5 and 1.25 hours, depending on the experience of the surgeon. The total construct failure rate for the ELM is 24.2% (6.6% at surgery failure + 17.8% postsurgery failures). This rate is consistent with that reported in spine implant studies with other devices. To date, more than 500 male Sprague-Dawley rats (350-450 g) have been implanted with SAUs for ELM studies at the Palmer Center for Chiropractic Research and the National University of Health Sciences.

CONCLUSION

It has been our experience that individuals with basic animal research training will become proficient at producing the ELM after observing 3 to 4 implant procedures and performing 4 to 6 procedures on their own.