UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033224 |
|---|---|
| Receipt number | R000037885 |
| Scientific Title | Clinical Outcomes and Complications of Achilles tendon repair with Percutaneous Achilles Repair System Versus Open Technique of Half-mini-Bunnellmethod for Acute Achilles Tendon Ruptures, a prospective, randomized, controlled trial |
| Date of disclosure of the study information | 2018/07/02 |
| Last modified on | 2024/01/31 12:47:40 |
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Basic information
Public title
Clinical Outcomes and Complications of Achilles tendon repair with Percutaneous Achilles Repair System Versus Open Technique of Half-mini-Bunnellmethod for Acute Achilles Tendon Ruptures, a prospective, randomized, controlled trial
Acronym
Outcomes of percutaneous versus open repair of acute Achilles tendon rupture
Scientific Title
Clinical Outcomes and Complications of Achilles tendon repair with Percutaneous Achilles Repair System Versus Open Technique of Half-mini-Bunnellmethod for Acute Achilles Tendon Ruptures, a prospective, randomized, controlled trial
Scientific Title:Acronym
Outcomes of percutaneous versus open repair of acute Achilles tendon rupture
Region
| Japan |
Condition
Condition
Acute Achilles Tendon Ruptures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the efficacy and safety between both Achilles tendon repairing methods
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the period to achieve single -legged heel raises
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
operative treatment with half-mini-bunnell method for patients suffering from acute Achilles tendon ruptures
Interventions/Control_2
operative treatment using PARS for patients suffering from acute Achilles tendon ruptures
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
| 19 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients suffering from acute Achilles tendon ruptures who select operation and treated operatively within 1 week
Key exclusion criteria
patients who have uncertain cause
patients suffering from both acute Achilles tendon ruptures
patients who have history of steroid injection for Achilles tendon
patients who have bone fracture besides acute Achilles tendon ruptures
patients who have avulsion fracture of calcaneus
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | AIZAWA |
Organization
Teine Keijinkai Hospital
Division name
Orthopedic surgery
Zip code
0068555
Address
12-1-40, Maeda1jo, Teine-ku, Sapporo, Hokkaido, Japan
TEL
0116818111
aizawa-te@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | AIZAWA |
Organization
Teine Keijinkai Hospital
Division name
Orthopedic surgery
Zip code
0068555
Address
12-1-40, Maeda1jo, Teine-ku, Sapporo, Hokkaido, Japan
TEL
0116818111
Homepage URL
aizawa-te@keijinkai.or.jp
Sponsor or person
Institute
Teine Keijinkai 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
Teine Keijinkai Hospital
Address
12-1-40, Maeda1jo, Teine-ku, Sapporo, Hokkaido, Japan
Tel
0116818111
taizawa0527@gmail.com
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
| 2018 | Year | 07 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
