UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique
Acronym	Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique (ASS Study)
Scientific Title	Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique
Scientific Title:Acronym	Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique (ASS Study)
Region	Japan

Condition
Condition	Fracture type is classified as 3-partB or 4-part fracture in 3D-CT classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT assessment.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare postoperative 2-3weeks fracture reduction maintenance rate between patients operated with ASS (investigational group) and patients operated without ASS (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The maintenance rate of postoperative 2-3 week reduction position.
Key secondary outcomes	The influence of surgery time / fracture type / postoperative reduction position / with or without ASS technique on CT evaluation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	At surgery, intervention group using ZNN CM Asia with ASS technique.
Interventions/Control_2	At surgery, conventional group using ZNN CM Asia without ASS technique.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Fracture type is classified as 3-partB or 4-part fracture in 3D-CT classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT assessment. 2. Japanese Male or female 3. not less than 20 years of age 4. Primary closed intertrochanteric fracture of the femur
Key exclusion criteria	1. Patient who cannot take CT image within 3 days after surgery. 2. Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Maehara
Organization	Kagawa Rosai Hospital
Division name	Orthopaedic Surgery
Zip code	763-8502
Address	3-1 Joto-cho 3-chome, Marugame, Kagawa, 763-8502 Japan
TEL	0877-23-3111
Email	yukako.nishino@zimmerbiomet.com

Public contact
Name of contact person	1st name Yukako Middle name Last name Shiraishi
Organization	Zimmer Biomet G.K.
Division name	Clinical Affairs
Zip code	105-0011
Address	11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan
TEL	03-6402-6771
Homepage URL
Email	yukako.nishino@zimmerbiomet.com

Sponsor
Institute	Zimmer Biomet G.K.
Institute
Department

Funding Source
Organization	Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	1
Address	1
Tel	1
Email	1

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT03196193
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2	jRCTs032180353
Org. issuing International ID_2	jRCT (Japan Registry of Clinical Trials)
IND to MHLW

Institutions
Institutions	香川労災病院（香川県）、岡山赤十字病院（岡山県）、佐賀県医療センター好生館（佐賀県）、岡山ろうさい病院（岡山県）、済生会高岡病院（富山県）、公立豊岡病院（兵庫県）、春日井市民病院（愛知県）、済生会熊本病院（熊本県）、沼津市立病院（静岡県）、JCHO星ヶ丘医療センター（大阪府）、九州中央病院（福岡県）、呉共済病院（広島県）、新潟中央病院（新潟県）、川崎幸病院（神奈川県）、藤枝市立総合病院（静岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 23 Day

Related information
URL releasing protocol	https://jrct.niph.go.jp/latest-detail/jRCTs032180353
Publication of results	Published

Result
URL related to results and publications	https://jrct.niph.go.jp/latest-detail/jRCTs032180353
Number of participants that the trial has enrolled	240
Results	This study showed that ASS technique can restrain the displacement of the proximal bone fragment to the intramedullary type and excessive sliding of lag screw which leads to postoperative complications such as re-dislodgement of bone fragment and cut-out, in the treatment of femoral trochanteric fractures without appropriate posterior bony support.
Results date posted	2022 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Japanese patients who injured closed, unstable femoral trochanteric fractures were enrolled in this study and randomly assigned to ZNN CM Asia with ASS technique group (ASS(+) group) or without ASS technique group (ASS(-) group) preoperatively. There was no significant difference in the baseline characteristics between the two groups (P >= 0.05). [Baseline Characteristics (ASS(+) group, ASS(-) group)] - Gender (M : F) 15 : 120, 22 : 97 - Age (y/o) 85.9 +/- 8.9, 86.7 +/- 7.9 - Height (cm) 148.9 +/- 8.8, 150.0 +/- 9.0 - Body Weight (kg) 45.3 +/- 9.8, 46.2 +/- 9.3 - BMI (kg/m2) 20.4 +/- 3.6, 20.6 +/- 3.2
Participant flow	A total of 237 of enrolled 240 cases were included in the analysis for the primary endpoint. [Change History of Number of Cases from IC to Statistics] - IC, Randomization 121, 119 - Follow-up Evaluation 120 (dropped 1 case*1), 119 - CT Image Analyses 118 (dropped 2 cases*2), 119 - Statistics 118, 119 *1 Revision surgery due to SAE (1) *2 No CT data collected (1), Deviation in CT image quality (1)
Adverse events	One SAE on one subject (0.42% (1/240)) was reported. Though the event was anticipated and serious, the patient reached remission after the revision surgery. The causal relationship with study devices and ASS technique have been denied by the chief principal investigator.
Outcome measures	1 Primary Endpoint 1.1 Maintenance rate of the reduction position at 2-3 week postoperatively When the changes in the reduction position from the immediate postoperative period to 2-3 week postoperatively were compared between the ASS(+) group and the ASS(-) group after exclusion of cases which already have the lateral type on frontal view and/or the intramedullary type on lateral view in the immediate postoperative period, the proportion of cases whose reduction position was maintained in both frontal and lateral views was significantly higher in the ASS(+) group compared with the ASS(-) group (93.4%(99/106), 79.1%(87/110): P=0.002). 2 Secondary Endpoints 2.1 Surgery Time The surgery time in the ASS(+) group, which requires additional screw insertion procedure, was significantly longer than that of the ASS(-) group (P=0.003). 2.2 Effect of fracture type on CT imaging measurements Regardless of the fracture type (3part B, 4part), the sliding distance was significantly restrained in the ASS(+) group (P<0.001, =0.025). However, there was no significant difference in the proportion of cases with sliding exceeding 4mm and the amount of displacement of the distal nail tip in the medullary cavity. 2.3 Effect of reduction position on CT imaging measurements In the ASS(+) group, the sliding distance and the proportion of cases with sliding exceeding 4mm were significantly restrained in cases with ideal reduction position (other than reduction position expressed as the lateral type on frontal view and/or the intramedullary type on lateral view) immediate postoperatively (P<0.001, =0.043). On the other hand, there was no difference in the amount of displacement of the distal nail tip in the medullary cavity between the two groups regardless of the postoperative reduction position (ideal or not ideal). 2.4 Effect of ASS on CT imaging measurements The sliding distance and the proportion of cases with sliding exceeding 4mm were significantly restrained in the ASS(+) group (P<0.001, =0.036). On the other hand, there was no difference in the amount of displacement of the distal nail tip in the medullary cavity between the two groups.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
Date of IRB	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 03 Month 08 Day
Last follow-up date	2020 Year 03 Month 21 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 04 Month 08 Day
Date analysis concluded	2020 Year 04 Month 16 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 22 Day
Last modified on	2022 Year 07 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030594