| CTRI Number |
CTRI/2024/09/073698 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Alignment of the lower limb after TKA with standard 5 degree valgus cut |
|
Scientific Title of Study
|
Radiological evaluation of pre and post operative alignment of lower limb with fixed 5 degree valgus cut in TKR for varus knee and its functional outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC2:35/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Umair Akram |
| Designation |
Junior Resident ,Department of Orthopaedics, Kasturba Medical College,Manipal |
| Affiliation |
Department of Orthopaedics,Kasturba Medical College,Manipal |
| Address |
Room 4,Orthopaedics OPD,Department of Orthopaedics,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9873226126 |
| Fax |
|
| Email |
umair.akram17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharath K Rao |
| Designation |
Professor,Department of Orthopaedics,Kasturba Medical College,Manipal |
| Affiliation |
Department of Orthopaedics,Kasturba Medical College,Manipal |
| Address |
Room 4,Orthopaedics OPD,Department of Orthopaedics,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845177418 |
| Fax |
|
| Email |
Sk.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Vijayan |
| Designation |
Additional Professor,Department of Orthopaedics,Kasturba Medical College,Manipal |
| Affiliation |
Department of Orthopaedics,Kasturba Medical College,Manipal |
| Address |
Room 4,Department of Orthopaedics,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449615291 |
| Fax |
|
| Email |
sandeep.vijayan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,Kasturba Medical College,Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Mohammad Umair Akram |
| Address |
Room 4,Department of Orthopaedics,Kasturba Medical College,Manipal 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mohammad Umair Akram |
Kasturba Medical College |
Department of Orthopaedics,Kasturba Medical College,Manipal 576104
Udupi
KARNATAKA |
9873226126
umair.akram17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with primary osteoarthritis.
2)Patients with only varus deformity at the knee joint.
3)Patients with less than 15 degree fixed flexion deformity .
4)Patients with minimum follow up of 1year post procedure |
|
| ExclusionCriteria |
| Details |
1)Patients with valgus deformity.
2)Patients who have undergone ipsilateral lower limb surgeries.
3)Patients with neurological disturbances.
4)Patients having secondary osteoathritis.
5)Patients who do not have post operative long leg views. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of correction |
Minimum 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement |
Minimum 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/09/2024 |
| 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="11"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective longitudinal study of patients having varus knee suffering from osteoarthritis in India in which fixed 5 degree valgus cut is given to patients undergoing Total Knee Replacement and over a minimum of 1year period of follow up the degree of correction will be assessed radiologically and the functional outcomes will also be assessed using scoring systems. |