THE INTERNATIONAL DOCUMENTATION AND EVALUATION SYSTEM IDES: DEVELOPMENT AND VALIDATION OF A MODULE FOR TOTAL ANKLE PROSTHESES

Abstract

Background: The number of total ankle replacements has been raising in the last years. Most publications present short- and medium-term results. Comparison of outcomes is difficult because of inconsistent terminology and different parameters used. Moreover, poorly performing implants cannot be identified quickly because of low numbers, delayed reporting or publication bias.

Methods: Therefore, we have developed a module for total ankle prostheses in the framework of the International Documentation and Evaluation System (IDES) for standardized and centralized documentation of TAA outcomes. Content validation was conducted with a single surgeon series of 74 HINTEGRA_ ankle replacements.

Results: Between March 2004 and February 2008 74 patients were treated. The preoperative diagnosis was 18.9% osteoarthritis, 32.4% rheumatoid arthritis, 43.3% posttraumatic, 1.4% osteonecrosis and 4% others. There were intraoperative complications in 4%, local postoperative complications in 17.6% and revision surgeries in 16.2% of patients. The AOFAS hind-foot score improved from 23.8 points preoperative to 75.3 points after a mean followup time of 8.4 months. No significant differences in outcome were revealed between the various diagnostic groups.

Conclusion: The IDES-forms facilitate a structured and standardized data collection that is feasible in a research orientated but also purely clinical setting; this because of the different extents to which data can be recorded. The consistent use of the system assures a stringent internal quality assurance, and more interesting, an external quality assurance by means of comparisons and benchmarking with other users feeding the data pool with the exact same variables and outcomes. The Hintegra ankle appeared as a safe device with low complication rates in the hands of a foot and ankle specialist. A surgical learning curve was seen in the first two years.