UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043929
Receipt number R000050163
Scientific Title Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Date of disclosure of the study information 2021/04/15
Last modified on 2021/04/16 20:03:03

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Basic information

Public title

Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures

Acronym

Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures

Scientific Title

Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures

Scientific Title:Acronym

Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures

Region

Japan


Condition

Condition

patients of femoral intertrochanteric fracture

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of cement augmentation on early postoperative ADL scores in patients with trochanteric fractures

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cumulated Ambulation Score(CAS) at postoperative days 1, 2, 3

Key secondary outcomes

Barthel index at post-op 1 week, walking ability (wheelchair, parallel bars, walker, cane, walking alone)
CAS at postoperative days 5


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

open reduction with cement augmentation

Interventions/Control_2

open reduction without cement augmentation

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

trochanteric fractures for the first time (Fracture type: AO/OTA classification 31A), age 60 years old above who able to walk independently before the injury (walking with a walker or higher, wheelchairs are excluded)

Key exclusion criteria

pathological fractures, open fractures, history of allergy to cement, multiple lower extremity trauma, postoperative non weight bearing, postoperative medical complications that make it difficult to leave the bed (pneumonia, heart failure, etc.)

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Mochizuki

Organization

Kaneda Hospital

Division name

orthopedics

Zip code

719-3193

Address

63, Nishihara, Maniwa city, Okayama

TEL

0867521191

Email

catchernine4949@yahoo.co.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Mochizuki

Organization

Kaneda Hospital

Division name

orthopedics

Zip code

719-3193

Address

63, Nishihara, Maniwa city, Okayama

TEL

0867521191

Homepage URL


Email

catchernine4949@yahoo.co.jp


Sponsor or person

Institute

Kaneda Hospital

Institute

Department

Personal name



Funding Source

Organization

Kaneda Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kaneda Hospital

Address

63, Nishihara, Maniwa city, Okayama

Tel

0867521191

Email

catchernine4949@yahoo.co.jp


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

2021 Year 04 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2021 Year 01 Month 31 Day

Date of IRB

2021 Year 02 Month 11 Day

Anticipated trial start date

2021 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 15 Day

Last modified on

2021 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050163


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name