UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique: Prospective comparative study.
Title of the study (Brief title)	The clinical outcomes and structural integrity of arthroscopic transosseous equivalent rotator cuff repair utilizing the knotless suture-bridge technique.
Region	Japan

Condition
Condition	rotator cuff tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study is to evaluate the structural integrity and clinical outcomes of arthroscopic rotator cuff repairs using the transosseous-equivalent (TOE) knotless suture bridge technique, comparing with those of conventional (single row or double row) repair, prospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical Assessment Pre- and postoperative clinical assessment consisted of a structured interview, a detailed physical examination, and evaluation using University of California at Los Angeles (UCLA) and Japanese Orthopaedic Association (JOA) scores. The scores obtained before- and 3-, 6-, 12-, 18-, and 24-months after the operation and at the latest follow-up were recorded.
Key secondary outcomes	Range of motion of the shoulder joint The structural integrity of the repaired rotator cuff was evaluated on MRI scans.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	conventional single row repair
Interventions/Control_2	knotless double row suture bridge repair
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	20 years-old <
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) arthroscopic repair of a full-thickness rotator cuff tear, (2) availability of pre- and post-operative magnetic resonance imaging (MRI) scans of the involved shoulder, and (3) a minimum follow-up of two years.
Key exclusion criteria	(1) an irreparable rotator cuff tear (2) a partial rotator cuff repair (3) cuff tear arthropathy on preoperative plain radiographs and at arthroscopy (4) stage 3- or 4 fatty infiltration of multiple rotator cuff muscles on T1-weighted MRI scans (5) a failed prior rotator cuff repair (6) a workers compensation claim
Target sample size	100

Research contact person
Name of lead principal investigator	Junji Ide
Organization	Kumamoto University
Division name	Advanced Joint Reconstructive Surgery
Address	1-1-1, Honjo, Central Ward, Kumamoto City, 860-8556, Japan
TEL	096-373-5226
Email	ide@kumamoto-u.ac.jp

Public contact
Name of contact person	Junji Ide
Organization	Kumamoto University
Division name	Advanced Joint Reconstructive Surgery
Address	1-1-1, Honjo, Central Ward, Kumamoto City, 860-8556, Japan
TEL	096-373-5226
Homepage URL
Email	seikeigeka@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 08 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 09 Month 30 Day
Anticipated trial start date	2012 Year 02 Month 17 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 04 Day
Last modified on	2017 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017155