UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Title of the study (Brief title)	Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Region	Japan

Condition
Condition	anterior cruciate ligament injury
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	KT side to side difference Pivot Shift test Crinical score CT MRI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Anatomical ACL reconstruction using intraoperative calcium phosphate-hybridization method
Interventions/Control_2	Coventional anatomical ACL reconstruction
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Anterior cruciate ligament injury
Key exclusion criteria	1. Patient having a skin disease 2. Patient having serious complications (heart disease, liver disease, renal disease) 3. Within five years before agreement day a patient with the past of the malignant tumor or the patient suspected to have it 4. The patient that during the pregnancy or the pregnancy is doubted 5. The patient who does not have ability for voluntary agreement 6. The patient that the acquisition of the written agreement is impossible 7. In addition, the patient who judged that the medical attendant was inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Hirotaka Mutsuzaki
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Department of Orthopaedic Surgery
Address	4669-2 Ami, Inashiki-gun, Ibaraki 300-0394
TEL	029-888-4000
Email	mutsuzaki@ipu.ac.jp

Public contact
Name of contact person	Hirotaka Mutsuzaki
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Department of Orthopaedic Surgery
Address	4669-2 Ami, Inashiki-gun, Ibaraki 300-0394
TEL	029-888-4000
Homepage URL
Email	mutsuzaki@ipu.ac.jp

Sponsor
Institute	Ichihara hospital
Institute
Department

Funding Source
Organization	Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 14 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022858