UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019941
Receipt number R000023024
Scientific Title The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Date of disclosure of the study information 2015/11/26
Last modified on 2024/01/23 00:09:17

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Basic information

Public title

The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement

Acronym

The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement

Scientific Title

The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement

Scientific Title:Acronym

The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement

Region

Japan


Condition

Condition

Osteoarthritis, Rheumatoid Arthritis,Osteonecrosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Purpose of the study:to reveal of the effectiveness of bone graft to the tibial interface in cementless total knee replacement.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Plain radiograph evaluation and bone density in 1 year after surgery.

Key secondary outcomes

Relationship between lower limb alignment and radiological-change surrounding pegs of tibial component.


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 not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Resected bone graft in total knee arthroplasty.

Interventions/Control_2

Normal total knee arthroplasty.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) the case that adapted to total knee arthroplasty.
(2) the case who obtained consent by document

Key exclusion criteria

Patients attending physician has determined ineligible(example bone defect, posterior cruciate ligament injury).

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazue
Middle name
Last name Hayakawa

Organization

Fujita Health University Hospital

Division name

Department of Orthopaedic Surgery

Zip code

4580919

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-2169

Email

hkazue@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Kazue
Middle name
Last name Hayakawa

Organization

Fujita Health University Hospital

Division name

Department of Orthopaedic Surgery

Zip code

4701192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-2169

Homepage URL


Email

hkazue@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Fujita Health University Hospital

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

Tel

0562932169

Email

hkazue@fujita-hu.ac.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

藤田医科大学病院(愛知県)/Fujita Health University Hospital(Aichi)


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 26 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

88

Results

Plain radiography showed significant longitudinal thickening of the trabecula below the peg (p < 0.05) and decreased occurrence of reactive lines (p = 0.07) in the bone filling group compared with the conventional group. BMD was significantly higher in the bone filling group in the medial region below the peg at 1, 3, and 6 months and in the central region at 1 and 3 months (all p < 0.05).

Results date posted

2024 Year 01 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

In this prospective, randomized, comparative study, we recruited consecutive patients scheduled to undergo TKA at the Department of Orthopedic Surgery, from March 2016 to January 2019.

Participant flow

randomized to the bone filling (48 joints) or conventional group (no bone filling; 40 joints)

Adverse events

none

Outcome measures

We performed clinical and plain radiographic evaluations after the operation and measured bone mineral density (BMD) at 5 sites below the component at 1, 3, 6, and 12 months postoperatively.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 10 Day

Date of IRB

2015 Year 09 Month 10 Day

Anticipated trial start date

2015 Year 12 Month 20 Day

Last follow-up date

2019 Year 12 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

2015 Year 11 Month 26 Day

Last modified on

2024 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name