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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
TCTR20210215004 |
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Date of registration:
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15/02/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of bone union on Computed tomography after open-wedge high tibial osteotomy with Beta-Tricalcium phosphate bone chips versus without any gap filling : a prospective, randomized control Trials
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Scientific title:
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Comparison of bone union on Computed tomography after open-wedge high tibial osteotomy with Beta-Tricalcium phosphate bone chips versus without any gap filling : a prospective, randomized control Trials |
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Date of first enrolment:
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08/04/2021 |
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Target sample size:
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50 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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www.thaiclinicaltrials.org/show/TCTR20210215004 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Wirat
Khongchareonsombut |
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Address:
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190 Silom road
10500
Bangkok
Thailand |
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Telephone:
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0813410854 |
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Email:
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v.lertpanasan@gmail.com |
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Affiliation:
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Lerdsin hospital |
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Name:
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Virakorn
Lertpanasan |
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Address:
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245/29 Moo.9 Central pattaya road, Nong prue, Banglamung
20150
Chonburi
Thailand |
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Telephone:
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0816832494 |
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Email:
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v.lertpanasan@gmail.com |
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Affiliation:
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Lerdsin hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age over 50 years
Isolated medial compartment knee OA with a varus malalignment as Kellgren-Lawrence grade 3-4
Exclusion criteria: History of infection around the surgical knee
History of systemic disease such as Rheumatoid arthritis, Chondrocalcinosis, Coagulopathy
Flexion contracture of surgical knee over 15 degrees
Age minimum:
50 Years
Age maximum:
99 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Artificial bone graft in HTO
Bone healing
Bone union
Bone graft
TCP
High tibial osteotomy
HTO
Computed tomography
CT
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Bone healing
Bone union
Bone graft
TCP
High tibial osteotomy
HTO
Computed tomography
CT
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Primary Outcome(s)
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Bone union 4 weeks CT scan
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Secondary Outcome(s)
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Pain score Post-op, 4 wk, 2 mo, 4 mo, 6 mo VAS score, WOMAC score, KOOS score,Mechanical axis change Post-op, 4 wk, 2 mo, 4 mo, 6 mo Film X-Ray,Complication (Allergic reaction, wound infection) Post-op, 4 wk, 2 mo, 4 mo, 6 mo Treatment of complication
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Lerdsin hospital
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Ethics review
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Status: Request not yet submitted
Approval date:
Contact:
lerdsin_hospital@hotmail.com
lerdsin_hospital@hotmail.com
023539800 Ext.
lerdsin_hospital@hotmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/04/2023 |
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URL:
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