| CTRI Number |
CTRI/2020/03/024328 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
26/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare results of 2 methods of high tibial osteotomies as a treatment modality for osteoarthritis knee |
|
Scientific Title of Study
|
Comparison Between Medial Open Wedge and Lateral Closing Wedge Osteotomies for Medial Compartment Osteoarthritis Knee- A Retrospective Cohort Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiju Majeed |
| Designation |
Additional Professor |
| Affiliation |
Government Medical College,Trivandrum |
| Address |
Department of Orthopaedics, Government Medical College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9495688685 |
| Fax |
|
| Email |
shiju78@live.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nabeel Thaha |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College,Trivandrum |
| Address |
Department of Orthopaedics,Government Medical College,Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9497474872 |
| Fax |
|
| Email |
nabeelthaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nabeel Thaha |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College,Trivandrum |
| Address |
Department of Orthopaedics,Government Medical College,Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9497474872 |
| Fax |
|
| Email |
nabeelthaha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Trivandrum |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiju Majeed |
Government Medical College,Thiruvananthapuram |
Department of Orthopaedics,Medical College P O ,Thiruvananthapuram
Thiruvananthapuram
KERALA |
9495688685
shiju78@live.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institional Etics committee,Government Medical College,Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Tibial Osteotomy |
Lateral Closing wedge in one cohort and Medial Open Wedge in other cohort |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Radiological evidence of medial compartment osteoarthritis (OA) with medial joint pain and varusmalalignment-grade 2 & 3.
2. Age: more than 18 years old
3. Sex: Both male and female
4. Patients who underwent surgery in study
5. Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. OA of the lateral compartment
2. Severe collateral ligament laxity
3. Patients not willing to participate in the study
4. Age above 60 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in Lysholm Knee Score |
One and half months after starting study, i.e, roud january 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correction to 4 degree of valgus |
After one and half months of starting the study,i.e, around january 15 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
study aims to compare the functional outcomes and radiological correction obtained following 2 different methods of high tibial osteotomy for medial compartment osteoarthritis knee. functional outcome is measured as imrovement in lysholm knee score and radiological correction is assesed by calculating hip knee ankle angle of 4 degree valgus correction. sample size of 26 each who had undergone respective surgeries in our department from 2012 to 2016 are studied as 2 separate retrospective cohorts and outcomes compared. ethical committe clearance will be sought. no monetary benefits or funds received for the study |