Lower extremity implant registries: has the time come in the United States?
Because of the current health care environment, involved parties are requesting the assessment of patient safety and efficacy following a lower extremity operation. Many foreign countries have registries to assess postoperative patient safety. A similar system does not exist in the United States. The purpose of this study was to create a registry to assess the safety and efficacy of lower extremity implants and procedures. The EVEREST Lower Extremity Registry is an Internet-based database designed to collect clinical outcomes and survivorship data of total ankle implants, hardware implants, and soft-tissue procedures. All data are collected remotely on a secure Web site. Data are collected at defined intervals according to implant or procedure. The investigators consent patients preoperatively using a central Institutional Review Board and are encouraged to enroll consecutive patients. Routine patient reports allow sites constant feedback regarding their patients versus the entire registry population. Patient engagement begins with providing a personalized implant card and is followed with the appropriate scheduling prompts based on interval due dates. Currently, there are 15 sites contributing data to the registry. There are 47, 79, and 27 patients enrolled in the total ankle, ankle hardware, and soft-tissue registries, respectively. Longest term follow-up collected is 12 months. Early outcomes suggest that many surgeons are willing to assimilate a registry system into their practice. This registry supports the critical need for data collection in lower extremity medicine.
Hyer
Christopher F
CF
Orthopedic Foot and Ankle Center, Westerville, Ohio, USA. ofacresearch@orthofootankle.com
Portera
William B
WB
Haglund
Emily M
EM
D000843:Ankle Joint / Q000601:surgery*; D019643:Arthroplasty, Replacement; D005260:Female; D006801:Humans; D007595:Joint Prosthesis; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D012042:Registries; D012449:Safety