UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057057 |
|---|---|
| Receipt number | R000065217 |
| Scientific Title | A case of using sonography to evaluate the repair process of a tissue defect over time after debridement for postoperative infection of Achilles tendon rupture |
| Date of disclosure of the study information | 2025/02/18 |
| Last modified on | 2025/02/17 20:23:38 |
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Basic information
Public title
A case of using sonography to evaluate the repair process of a tissue defect over time after debridement for postoperative infection of Achilles tendon rupture
Acronym
A case of using sonography to evaluate the repair process of a tissue defect over time after debridement for postoperative infection of Achilles tendon rupture
Scientific Title
A case of using sonography to evaluate the repair process of a tissue defect over time after debridement for postoperative infection of Achilles tendon rupture
Scientific Title:Acronym
A case of using sonography to evaluate the repair process of a tissue defect over time after debridement for postoperative infection of Achilles tendon rupture
Region
| Japan |
Condition
Condition
Postoperative infection of Achilles tendon rupture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment of postoperative infection of the Achilles tendon rupture involves reconstruction or free flaps, but these are often difficult. In recent years, there have been reports of treating infected Achilles tendons with debridement alone, without reconstruction, and the results have been good. Postoperative progress has almost always been monitored using magnetic resonance imaging (MRI), and there have been no reports of chronological observation using sonography. The purpose of this study was to perform debridement in postoperative infection of the Achilles tendon rupture and observe the repair process of the defective tissue over time using sonography.
Basic objectives2
Others
Basic objectives -Others
Comparison of MRI and sonography images of tissue defects after debridement for post-operative Achilles tendon infection at 24 and 48 weeks postoperatively
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sonography images of the Achilles tendon defect at 4, 8, 12 and 16 weeks postoperatively
Key secondary outcomes
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Patients undergoing debridement for infection after Achilles tendon rupture
Key exclusion criteria
Patients who have chosen conservative treatment or surgery other than debridement for infection after Achilles tendon rupture surgery
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Division name
Orthopaedic surgery
Zip code
263-8522
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan.
TEL
+81-43-226-2117
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Division name
Orthopaedic surgery
Zip code
263-8522
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan.
TEL
+81-43-226-2117
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan.
Tel
0432227171
y-satoshi@faculty.chiba-u.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
| 2025 | Year | 02 | Month | 18 | 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
1
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065217
