UMIN-ICDS Clinical Trial

Public title

Proximal humerus reconstruction after malignant tumor resection: a single-arm meta-analysis and systematic review

Acronym

Proximal humerus reconstruction after malignant tumor resection: a single-arm meta-analysis and systematic review

Scientific Title

Proximal humerus reconstruction after malignant tumor resection: a single-arm meta-analysis and systematic review

Scientific Title:Acronym

Proximal humerus reconstruction after malignant tumor resection: a single-arm meta-analysis and systematic review

Region

Japan

Condition

Bone tumor in proximal humerus

Classification by specialty

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of our study was to analyze all-inclusively the functional results, reconstruction survival and complications of different reconstruction techniques based a meta-analysis and systematic review of objectively integrated and weighted data. 

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Funtional outcome of upper limbe; Prosthesis survival; complication

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

English-language articles on proximal humerus resection for malignant bone tumors with a minimum follow-up of 2 years.

Key exclusion criteria

We excluded case reports and case series with less than 4 patients, reconstruction methods only for benign or metastatic bone tumors, intercalary/distal humerus reconstruction, and reconstruction following fracture or osteomyelitis.

Target sample size

2000

Name of lead principal investigator

1st name	Hisaki
Middle name
Last name	Aiba

Organization

Nagoya City University

Division name

Department of Orthopaedic Surgery

Zip code

467-8501

Address

1, Azakawasumi, Mizuho-cho. Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8236

Email

hisakiaiba@yahoo.co.jp

Name of contact person

1st name	Hisaki
Middle name
Last name	Aiba

Organization

Nagoya City University

Division name

Department of Orthopaedic Surgery

Zip code

467-8601

Address

1, Azakawasumi, Mizuho-cho. Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8236

Homepage URL

Email

hisakiaiba@yahoo.co.jp

Institute

Nagoya City University

Institute

Department

Personal name

Organization

Not applicable

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Not applicable

Address

Not applicable

Tel

052-853-8236

Email

hisakiaiba@yahoo.co.jp

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

2023

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2023

Year

08

Month

01

Day

Last follow-up date

2023

Year

08

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data collection
We collected the following from each study using a data collection sheet and separated into each group: (1) basic data (author name, year of publication, journal name, study type, investigation period, number of patients, patient age, and tumor histology) and the range of resection, categorized by Malawer et al17. or Musculoskeletal Tumor Society (MSTS).; (2) postoperative functional outcome assessed using the MSTS score; the reconstruction; and (4) complications, as categorized by Henderson et al.

Methodological quality assessment
0-4, very low quality; 5-8, low quality; 9-12, moderate quality; 13-16, high quality20. 19-24, high quality. Disagreements were resolved through discussion between the authors (H.A., A.A., and C.E.).

Statistical analyzes
We performed a single-arm meta-analysis of the data from the selected studies. A random-effects or fixed-effect model was used to calculate the pooled incidences of implant failure rate 5 years after surgery and MSTS score. Summary effect measures are presented with their corresponding 95% confidence intervals (CI). Statistical heterogeneity was evaluated using the I2 statistic. indicated insignificant, low, moderate, and high levels of heterogeneity, respectively21. A random-effects model was used if I2>50%; otherwise, a fixed-effects model was used. Statistical analyzes were performed using Review Manager version 5.3 (The Cochrane Collaboration 2014, The Nordic Cochrane Centre, Copenhagen, Denmark). We calculated the standard deviation (SD) and standard error (SE) from the information in the articles or assumed these values from the range 22, and only data with SD or SE were included in the analysis. Statistical significance was set at p<0.05 for all analyzes.

Registered date

2023

Year

07

Month

24

Day

Last modified on

2023

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059005