UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048111 |
|---|---|
| Receipt number | R000054833 |
| Scientific Title | Megaprosthetic reconstruction of distal femur with short residual proximal femur following resection of bone tumor: a systematic review |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2023/06/20 16:24:36 |
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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
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
shinji104@mail.goo.ne.jp
Sponsor or person
Institute
Nara medical university
Institute
Department
Personal name
Funding Source
Organization
Nara medical university
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 18 | Day |
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
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054833
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