J Korean Foot Ankle Soc.  2014 Dec;18(4):195-201. 10.14193/jkfas.2014.18.4.195.

Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty

• Park JO
• Lee M
• Lee JW
• Lee SB
• Han SH

• KMID: 2181641
• DOI: http://doi.org/10.14193/jkfas.2014.18.4.195

Abstract

PURPOSE
The purpose of this study is to develop guidelines for clinical trial of the total ankle replacement system for premarket approval.
MATERIALS AND METHODS
We selected and analyzed nine peer-reviewed articles whose quality had been proven in a previous phase. Two investigators extracted parameters for guideline criteria, including number of cases, patient age, follow-up period, failure rate, radiographic osteolysis rate, residual pain rate, and percentage of satisfaction. In addition, the inclusion and exclusion criteria were analyzed and developed.
RESULTS
Eight level IV studies and one level II study were included. The average number of cases was 159 cases and the mean patient age was 63.5 years. The mean follow-up period was 4.2 years, ranging from two to nine. The average failure rate of total ankle replacement in mid- to long-term follow-up was approximately 13% (2%~32.3%). The rate of osteolysis was approximately 18%. Residual pain was common (21.4%~46%), but overall patient satisfaction was approximately 85.6% (67.5%~97%).
CONCLUSION
The results could be used as criteria for designing the clinical studies, such as number of cases, patient age (over 60 years), and follow-up period (minimum two years). The clinical scoring system and 36-item short form health survey (SF-36) was the most commonly used method for clinical evaluation for total ankle arthroplasty. In addition, the overall results, including failure rate, osteolysis rate, and patient satisfaction, could be used as a parameter of guidelines for premarket approval.

Keyword

Ankle; Arthritis; Ankle replacement arthroplasty; Clinical trial; Guideline

MeSH Terms

Ankle*
Arthritis
Arthroplasty*
Arthroplasty, Replacement, Ankle
Follow-Up Studies
Health Surveys
Humans
Osteolysis
Patient Satisfaction
Research Personnel

Reference

1.Lord G., Marotte JH. Total ankle prosthesis. Technic and 1st results. Apropos of 12 cases. Rev Chir Orthop Reparatrice Appar Mot. 1973. 59:139–51.

2.Gougoulias NE., Khanna A., Maffulli N. History and evolution in total ankle arthroplasty. Br Med Bull. 2009. 89:111–51.

3.Cracchiolo A 3rd., Deorio JK. Design features of current total ankle replacements: implants and instrumentation. J Am Acad Orthop Surg. 2008. 16:530–40.

4.Anderson T., Montgomery F., Carlsson A. Uncemented STAR total ankle prostheses. Three to eight-year follow-up of fifty-one consecutive ankles. J Bone Joint Surg Am. 2003. 85:1321–9.

5.Bonnin M., Judet T., Colombier JA., Buscayret F., Graveleau N., Piriou P. Midterm results of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res. 2004. 424:6–18.

6.Hurowitz EJ., Gould JS., Fleisig GS., Fowler R. Outcome analysis of agility total ankle replacement with prior adjunctive procedures: two to six year followup. Foot Ankle Int. 2007. 28:308–12.

7.Knecht SI., Estin M., Callaghan JJ., Zimmerman MB., Alliman KJ., Alvine FG, et al. The Agility total ankle arthroplasty. Seven to sixteen-year follow-up. J Bone Joint Surg Am. 2004. 86:1161–71.

8.Saltzman CL., Mann RA., Ahrens JE., Amendola A., Anderson RB., Berlet GC, et al. Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results. Foot Ankle Int. 2009. 30:579–96.

9.Schweitzer KM., Adams SB., Viens NA., Queen RM., Easley ME., Deorio JK, et al. Early prospective clinical results of a modern fixed-bearing total ankle arthroplasty. J Bone Joint Surg Am. 2013. 95:1002–11.

10.Valderrabano V., Hintermann B., Dick W. Scandinavian total ankle replacement: a 3.7-year average followup of 65 patients. Clin Orthop Relat Res. 2004. 424:47–56.

11.Valderrabano V., Pagenstert G., Horisberger M., Knupp M., Hinter-mann B. Sports and recreation activity of ankle arthritis patients before and after total ankle replacement. Am J Sports Med. 2006. 34:993–9.

12.Wood PL., Prem H., Sutton C. Total ankle replacement: medium-term results in 200 Scandinavian total ankle replacements. J Bone Joint Surg Br. 2008. 90:605–9.

13.Takakura Y., Tanaka Y., Kumai T., Tamai S. Low tibial osteotomy for osteoarthritis of the ankle. Results of a new operation in 18 patients. J Bone Joint Surg Br. 1995. 77:50–4.

14.Kellgren JH., Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957. 16:494–502.

15.Kofoed H. Cylindrical cemented ankle arthroplasty: a prospective series with long-term follow-up. Foot Ankle Int. 1995. 16:474–9.

16.Kitaoka HB., Alexander IJ., Adelaar RS., Nunley JA., Myerson MS., Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994. 15:349–53.

17.Buechel FF., Pappas MJ., Iorio LJ. New Jersey low contact stress total ankle replacement: biomechanical rationale and review of 23 cementless cases. Foot Ankle. 1988. 8:279–90.

18.Domsic RT., Saltzman CL. Ankle osteoarthritis scale. Foot Ankle Int. 1998. 19:466–71.

19.Martin RL., Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007. 37:72–84.

20.Ware JE Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992. 30:473–83.

21.Hintermann B., Valderrabano V., Dereymaeker G., Dick W. The HINTEGRA ankle: rationale and short-term results of 122 consecutive ankles. Clin Orthop Relat Res. 2004. 424:57–68.

22.Roos EM., Brandsson S., Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001. 22:788–94.

23.Lee KM., Chung CY., Kwon SS., Sung KH., Lee SY., Won SH, et al. Transcultural adaptation and testing psychometric properties of the Korean version of the Foot and Ankle Outcome Score (FAOS). Clin Rheumatol. 2013. 32:1443–50.