UMIN-CTR Clinical Trial

Public title

Above or below-elbow fixation for conservative treatment of distal radius fracture: systematic review and meta-analysis

Acronym

Above or below-elbow fixation for conservative treatment of distal radius fracture: systematic review and meta-analysis

Scientific Title

Above or below-elbow fixation for conservative treatment of distal radius fracture: systematic review and meta-analysis

Scientific Title:Acronym

Above or below-elbow fixation for conservative treatment of distal radius fracture: systematic review and meta-analysis

Region

Japan

Condition

Distal radius fracture

Classification by specialty

Orthopedics

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study will be to clarify the safety and effectiveness between below-elbow and above-elbow fixation for conservative treatment of distal radius fractures.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. The mean score of self-rated upper-extremity disability and symptoms at short-term (up to 6 weeks) measured by Disabilities of the arm, shoulder and hand (DASH).
2. The mean score of self-rated upper-extremity disability and symptoms at final follow up, measured by DASH.
3. The rate of treatment failure
Outcome defined as either the need for a secondary procedure (repeated reduction, conversion to surgical treatment) or the presence of loss of reduction. The definition of the loss of reduction will be set by the authors of the original study.

Key secondary outcomes

1. The mean loss of reduction of each radiographic parameter at the final follow up
1)Radial inclination(RI) (degree)
2)Radial Height (RH) (mm)
3)Ulnar Variance (UV) (mm)
4)Palmar tilt (PT) (degree)
2. The mean score of self-rated wrist pain and disability measured by Patient-rated wrist evaluation (PRWE). We will accept other measures used in original studies.
3. The mean score of pain at the final follow up, measured by visual analog scale (VAS) score, numeric rating scale (NRS) or verbal rating scale (VRS) evaluated using questionnaires and/or by interview. These scores are defined as numerical scale, which report no pain as the lowest score and worst imaginable pain as the highest score.
4. All adverse events. Definition of adverse events are set by original authors.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Type of studies:
We will include randomized controlled trials that assess the range of fixation of the conservative treatment of the distal radius fracture. We do not set language or country restrictions. We will include all papers including published, unpublished articles, abstract of conference and letter. We will exclude crossover trial, cluster-randomized trial, quasi-experimental studies and quasi-randomized trial. We do not exclude studies based on the observation period.

Study participants:
Patients who has sustained distal radius fractures and undergoes the conservative treatment
Inclusion criteria:
18 years-old or older, includes all Arbeitsgemeinschaft fur Osteosynthesefragen/Orthopedic Trauma Association (AO/OTA) classification

Key exclusion criteria

Exclusion criteria:
open fractures, patients associated with injury in other parts, bilateral distal radius fractures

Target sample size

Name of lead principal investigator

1st name	Natsumi
Middle name
Last name	Saka

Organization

Teikyo University School of Medicine

Division name

Department of Orthopaedics

Zip code

1738606

Address

2-11-1 Kaga, Itabashi, Tokyo

TEL

0339641211

Email

natsumi613@gmail.com

Name of contact person

1st name	Natsumi
Middle name
Last name	Saka

Organization

Teikyo University School of Medicine

Division name

Department of Orthopaedics

Zip code

1738606

Address

2-11-1 Kaga, Itabashi, Tokyo

TEL

0339641211

Homepage URL

Email

natsumi613@gmail.com

Institute

Department of Orthopaedics, Teikyo University School of Medicine

Institute

Department

Personal name

Organization

None/ Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Orthopaedics, Teikyo University School of Medicine

Address

2-1-1 kaga, itabashi, Tokyo

Tel

0339641211

Email

natsumi613@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

04

Month

14

Day

URL releasing protocol

http://upload.umin.ac.jp/rd/rd.cgi?t=sa&n=R000045654&k=90038n0ja1yzCEmwZJs75e3R

Publication of results

Published

URL related to results and publications

https://www.sciencedirect.com/science/article/abs/pii/S002013832101007X

Number of participants that the trial has enrolled

909

Results

There was no significant difference in DASH score in the short-term follow-up and treatment failure. A clinically irrelevant but significant mean difference (0.83 lower, 95%CI: 1.64 lower to 0.03 lower; low certainty) was found in the DASH score in favour of below-elbow immobilization in the long-term follow-up. There was no significant difference in secondary outcome measures.

Results date posted

2021

Year

12

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

441 participants in the below-elbow group and 416 in the above-elbow group

Participant flow

each result was analyzed in accordance with the protocol

Adverse events

Adverse events were evaluated in five studies

Outcome measures

DASH score in the short-term follow-up (4.99 lower, 95% confidence interval (CI): 10.45 lower to0.46 higher; very low certainty) and treatment failure (risk ratio: 0.91, 95% CI: 0.59 to 1.40; low certainty). A clinically irrelevant but significant mean difference (0.83 lower, 95%CI: 1.64 lower to 0.03 lower; low certainty) was found in the DASH score in favour of below-elbow immobilization in the long-term follow-up.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

04

Month

13

Day

Date of IRB

2020

Year

04

Month

13

Day

Anticipated trial start date

2020

Year

04

Month

13

Day

Last follow-up date

2020

Year

10

Month

12

Day

Date of closure to data entry

2021

Year

12

Month

11

Day

Date trial data considered complete

2021

Year

12

Month

11

Day

Date analysis concluded

2021

Year

12

Month

11

Day

Other related information

<Search method>
Electronic serach
1. the Cochrane Central Register of Controlled Trials(CENTRAL)
2. MEDLINE via Ovid
3. EMBASE
Other resources
1.the World Health Organization International Clinical Trials Platform Search Portal (ICTRP)
2.ClinicalTrials.gov.
We will check the reference lists of studies, including international guidelines as well as the reference lists of eligible studies and articles citing eligible studies. We will ask the authors of original studies for unpublished or additional data.
<Meta-analysis>
Meta-analysis will be performed using Stata V.16 (StataCorp LLC, College Station, texas, United State of America). We will use a random-effects model.
<Subgroup analysis>
To elucidate the influence of effect modifiers on results, we will evaluate the subgroup analyses of the primary outcomes on the following factors when sufficient data are available.
1. Type of fracture: subgroups will be articular fractures and extra articular fractures
2. Age: subgroups will be elderly patients and younger patients
3. Type of fixation: subgroups will be circular cast and splint
<Sensitivity analysis>
We will undertake sensitivity analyses for the primary outcome to assess whether the results of the review are robust to the decisions made during the review process. We plan to examine the effects of the review findings of:
1.Exclusion of studies using imputed statistics;
2. Missing participants;
3. Exclusion of studies which does not state the inclusion criteria of radiographic findings before fixation; and
4. Exclusion of studies which report the functional outcome other than DASH or PRWE.

Registered date

2020

Year

04

Month

12

Day

Last modified on

2021

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045654