臨床研究等提出・公開システム

Date of registration	Dec. 03, 2023
Last modified on	Dec. 03, 2023
Trial ID	jRCT1020230043

Scientific Title	Relationship between age and postoperative results of radial wedge osteotomy for Kienboeck's disease Lichtman classification stages IIIa and IIIb
Public Title	Relationship between age and postoperative results of radial wedge osteotomy for Kienboeck's disease

Contact for Scientific Queries	Name	Yokota Takeru
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1276
	E-mail	yokota_ishi_takeru@yahoo.co.jp
Contact for Public Queries	Name	Yokota Takeru
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1276
	E-mail	yokotake@fmu.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Jan. 01, 2012
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	assignment	factorial assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(i) Patients diagnosed with stage IIIa or IIIb Kienboeck's disease according to the Lichtman classification at the Department of Orthopaedic Surgery of Fukushima Medical University and Iwaki City Medical Centre. (ii) Patients who have undergone radial wedge osteotomy. (iii) Patients for whom one year has passed since the operation.
	Exclusion Criteria	none
	Age Minimum	0age No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Kienboeck disease
Health Condition(s) Keyword		Kienboeck disease
Health Condition(s) Code		D010020
Primary Outcome(s)		Age cut-off values for post-operative outcomes in clinical and radiological outcomes Clinical outcome: Binarised into excellent/good and fair/poor groups based on Cooney's score and calculated using ROC curves. Clinical outcome: Binarised into excellent/good and fair/poor groups based on Cooney's score, and the ROC curve is used to calculate the age cut-off value. Radiological results: ROC curves are used to calculate age cut-off values for the presence or absence of lunate fusion in simple X-rays. Radiological results: Calculate the age cut-off value using the ROC curve for the presence of lunate fusion in simple X-rays.
Secondary Outcome(s)		Compare outcomes between groups by separating younger and older age groups for each outcome using the age cut-off values for clinical and radiological outcomes. (i) Clinical outcomes. Grip strength, pain and joint range of motion DASH score Cooney's score (ii) Radiological outcomes Presence of lunate fusion Lichtman classification Carpal height ratio, Stahl index

Primary Sponsor	Fukushima Medical University

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Fukushima Medical University Certified Review Board
Address	1 Hikarigaoka, Fukushima city, Fukushima, Japan, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmucrb@fmu.ac.jp

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none