UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057237 |
|---|---|
| Receipt number | R000065425 |
| Scientific Title | Quadriceps tendon and hamstrings as graft materials for anterior cruciate ligament reconstruction: a randomized control trial |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/07 17:14:13 |
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Basic information
Public title
Extensor and flexor tendons as graft materials for anterior cruciate ligament reconstruction: a comparative study
Acronym
Graft materials for anterior cruciate ligament reconstruction: a comparative study
Scientific Title
Quadriceps tendon and hamstrings as graft materials for anterior cruciate ligament reconstruction: a randomized control trial
Scientific Title:Acronym
Graft materials for anterior cruciate ligament reconstruction: a comparative study
Region
| Japan |
Condition
Condition
anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of outcomes after anterior cruciate reconstruction between using quadriceps tendon and hamstrings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KOOS score, operative time, surgical findings, blood examination findings, amount of bleeding, hospitalization period, muscle power, range of motion, anterior instability of the knee, JOA score, Knee Society Score, physical outcomes, imaging findings
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
quadriceps tendon group
Interventions/Control_2
knee flexor tendon group
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
| 16 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have arthroscopic anterior cruciate ligament reconstruction in Saitama Medical Center, Saitama Medical University.
Key exclusion criteria
1) Those who could not obtain or withdrew written consent
2) Those with a history of meniscus injury (excluding those associated with anterior cruciate ligament injury), fracture, knee osteoarthritis, or previous surgery
3) Cases of re-rupture of the anterior cruciate ligament
4) Cases of combined ligament injury besides medial collateral ligament injury that does not require surgery
5) Those with anterior cruciate ligament injury for > 2 years
6) Those with a history of ligament injury in the contralateral knee
7) Those with walking difficulties before an injury
8) Those with a desired graft tendon to be used
9) Those for whom the surgeon judges it appropriate to use a specific graft tendon
10) Those aged < 16 years or > 59 years
11) Those who the principal investigator judges to be inappropriate for other reasons
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | NAKAMURA |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Orthopaedics,
Zip code
3508550
Address
1981 Kamoda, Kawagoeshi, Saitama, Japan
TEL
0492283627
hnak@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | NAKAMURA |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Orthopaedics
Zip code
3508550
Address
1981 Kamoda, Kawagoeshi, Saitama, Japan
TEL
0492283627
Homepage URL
hnakamura-tky@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical 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
IRB in Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoeshi, Saitama, Japan
Tel
0492283902
smcrinri@saitama-med.ac.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 | 04 | Month | 01 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2035 | Year | 03 | 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
| 2025 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065425
