UMIN-CTR Clinical Trial

Basic information
Public title	Megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor: a systematic review
Acronym	Megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor: a systematic review
Scientific Title	Megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor: a systematic review
Scientific Title:Acronym	Megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor: a systematic review
Region	Japan Europe

Condition
Condition	bone tumor
Classification by specialty	Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the risk of postoperative function and complications in patients with short residual proximal femur after resection of a distal femoral bone tumor, we performed a systematic review of studies reporting functional results and complications in patients with short residual proximal femur after reconstruction of a distal femoral bone tumor with custom-made megaprosthesis, APC and CPS implant.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mechanical survival where the endpoint was set to implant removal for any reason
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Only studies reporting functional results and complications regarding megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor were included.
Key exclusion criteria	(1) Studies in which reconstruction was performed in patients without short residual proximal femurs were excluded. Studies that performed reconstruction in patients with short residual proximal femurs and did not specify both functional results and complications were also excluded. (2) Only English- and Japanese-language literature was included, with no restriction on the year of publication.
Target sample size

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Tsukamoto
Organization	Nara medical university
Division name	Department of Orthopaedic Surgery
Zip code	634-8521
Address	840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL	0744223051
Email	shinji104@mail.goo.ne.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Tsukamoto
Organization	Nara Medical University
Division name	Department of Orthopaedic Surgery
Zip code	634-8521
Address	840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL	0744223051
Homepage URL
Email	shinji104@mail.goo.ne.jp

Sponsor
Institute	Nara medical university
Institute
Department

Funding Source
Organization	Nara medical university
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University
Address	840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan
Tel	0744223051
Email	shinji104@mail.goo.ne.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	2022 Year 06 Month 20 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	Preinitiation
Date of protocol fixation	2022 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 20 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Data collection and presentation Two authors (ST and TM) independently selected the studies and extracted the data. In case of any disagreement, agreement was reached between the two or the third author was consulted. The following data were collected using the data collection sheet. (1) Basic data: author, year of publication, journal name, type of study, number of patients, age of patients, histology of tumor (2) Surgical indication, method of reconstruction, cement fixation, porous coating, time to full weight bearing, stem length of prosthesis, adjuvant chemotherapy, adjuvant radiotherapy, nonunion, aseptic loosening, implant breakage, fracture, infection, mechanical survival where the endpoint was set to implant removal for any reason, oncological outcome, Musculoskeletal Tumor Society (MSTS) score [19], postoperative follow-up period. Data summary Data extracted from the collected study data are summarized in Table 1 and 2. Table 3 summarized the time to full weight bearing, nonunion, aseptic loosening, implant breakage, fracture, infection, mechanical survival, MSTS score [19], and postoperative follow-up period for each reconstruction method (custom-made megaprosthesis, APC, and CPS implant). Because all the studies included in this review were non-randomized, data pooling (meta-analysis) was not appropriate, and thus, not performed. Assessment of methodological quality Two authors (ST and TM) independently assessed the quality of the included studies. When there was disagreement, agreement was reached between the two authors or by consulting a third author. Articles included in the final analysis were independently assessed according to the Risk of Bias Assessment tool for Non-randomized Studies (RoBANS tool) for assessing the quality of non-randomized studies in meta-studies [20].

Management information
Registered date	2022 Year 06 Month 20 Day
Last modified on	2022 Year 06 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054833

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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