UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Zimmer Biomet G.K.

Institute

Department

Personal name

Organization

Zimmer Biomet G.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

1

Address

1

Tel

1

Email

1

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

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）

Date of disclosure of the study information

2017

Year

03

Month

23

Day

URL releasing protocol

https://jrct.niph.go.jp/latest-detail/jRCTs032180353

Publication of results

Published

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

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 related information

Registered date

2017

Year

03

Month

22

Day

Last modified on

2022

Year

07

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030594