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

Jin Oh Park; Moses Lee; Jin Woo Lee; Soo Bin Lee; Seung Hwan Han

doi:10.14193/jkfas.2014.18.4.195

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Park, Lee, Lee, Lee, and Han: Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty

Original Article

J Korean Foot Ankle Soc 2014;18(4):195-201.

Published online: 19 January 2014

DOI: https://doi.org/10.14193/jkfas.2014.18.4.195

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

Jin Oh Park, Moses Lee, Jin Woo Lee, Soo Bin Lee, Seung Hwan Han

Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea

Corresponding Author: Seung Hwan Han Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Korea Tel: 82-2-2019-3410, Fax: 82-2-573-5393, E-mail: osmedic@yuhs.ac.

Received 6 October 201429 October 2014 Accepted 29 October 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Ankle, Arthritis, Ankle replacement arthroplasty, Clinical trial, Guideline

REFERENCES

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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.

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Table 1.

Patient Number, Age, and Follow-up Period of Selected Articles

Study	First author	Level of study	Prosthesis	Cases (n)	Mean age (yr)	Mean follow-up (yr)
1	Hurowitz⁶⁾	IV	Agility	62	54.5	3.3
2	Knecht⁷⁾	IV	Agility	132	61	9
3	Anderson⁴⁾	IV	STAR	51	57	4.3
4	Valderrabano¹⁰⁾	IV	STAR	68	56	3.7
5	Wood¹²⁾	IV	STAR	200	59.6	7.3
6	Saltzman⁸⁾	II	STAR	593	63	2
7	Bonnin⁵⁾	IV	Salto	98	56	2.9
8	Schweitzer⁹⁾	IV	Salto	75	63	2.8
9	Valderrabano¹¹⁾	IV	Hintegra	152	59.6	2.8
Mean				159.0	63.5	4.2

Refer to Table 4 for the company information of prosthesis except in the case of Agility (DePuy, USA).

Table 2.

Survivorship and Clinical Results of Implants

Study	First author	Prosthesis	Failure (%)	Osteolysis (%)	Residual pain (%)	Satisfaction (%)
1	Hurowitz⁶⁾	Agility	23.5	46	33	85
2	Knecht⁷⁾	Agility	2	1	21.4	92
3	Anderson⁴⁾	STAR	32.3	20	-	-
4	Valderrabano¹⁰⁾	STAR	10.6	14	27	90
5	Wood¹²⁾	STAR	13.2	15	46	97
6	Saltzman⁸⁾	STAR	8.6	2	31	83
7	Bonnin⁵⁾	Salto	12	12.5	33	67.5
8	Schweitzer⁹⁾	Salto	4	39	-	-
9	Valderrabano¹¹⁾	Hintegra	10.6	15.2	34	85
Mean			13.0	18.3	32.2	85.6

Values are presented as mean. Refer to Table 4 for the company information of prosthesis except in the case of Agility (DePuy, USA).

Table 3.

Classification of Total Ankle Replacement Implant in Korean Food and Drug Admisitration

Item category code	Class	Item name
B03010.01	3	Prosthesis, ankle, internal total
B03010.02	4	Prosthesis, ankle, internal total biodegradable

Table 4.

List of Available Total Ankle Replacement System in Current Market

Market	Name	Company	Nation	Component	Class
Domestic	Hintegra	Newdeal	France	3	3
	Salto	Tornier	USA	3	3
	Mobility	DePuy	EU	3	3
	Zenith	Corin	England	3	3
International	INBONE	Wright Medical	USA	2	3
	Buechel-Pappas	Endotec	USA	3	3
	Ecplipse	Integra Life Science	USA	3	3
	TARIC	Implantcast GmbH	Germany	3	3
	German Ankle system	Arge Medizintechnik	Germany	3	3
	ESKA	ESKA Implant	Germany	2	3
	BOX	Finsbury Orthopaedics	England	3	3
	Albatros	Groupe Lepine	France	3	3
	Ramses	Maitrise Orthopatique	France	3	3
	Ankle Evolution	Biomet	Netherlands	3	3
	CCI Evolution	Van Straten Medical	Netherlands	3	3
	Alphamed Orthner	Alphamed	Austria	3	3
	TNK	Kyocera	Japan	2	4
	Trabecular Metal	Zimmer	USA	3	4
	STAR	Small Bone Innovation	USA	3	4

Table 5.

Inclusion and Exclusion Criteria of Clinical Trial Protol in Total Ankle Replacement System

Inclusion criteria	- Severe pain, loss of function related with ankle joint
	- End stage primary osteoarthritis, post-traumatic arthritis (Takakura stage IIIb, IV, Kellgren & Lawrence grade III, IV)
	- At least 6 months of conservative care with confirmation of medical record, X-ray, medication record
Exclusion criteria	- Low bone maturity
	- Active or deep infection of ankle joint
	- Lower extremity peripheral arterial occlusive disease
	- Uncontrolled diabetes mellitus
	- History of ankle arthrodesis
	- Hindfoot angulation more than 35^o/forefoot malalignment inhibiting plantigrade foot
	- Obesity (>115 kg)
	- Avascular necrosis of distal tibia

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