UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026639
Receipt number R000030594
Scientific Title Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique
Date of disclosure of the study information 2017/03/23
Last modified on 2022/07/25 11:00:08

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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 or person

Institute

Zimmer Biomet G.K.

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name