| CTRI Number |
CTRI/2024/07/071637 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Difference in gait between different types of total knee arthroplasties in osteoarthritic patients |
|
Scientific Title of Study
|
Comparison of gait following Mechanically Aligned and callipered restricted Kinematically Aligned Total Knee Arthroplasty -
A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshitij Gupta |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Orthopaedics
Level-6
All India Institute of Medical Sciences, Rishikesh
Virbhadra Road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
918745851828 |
| Fax |
|
| Email |
kshitizg001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Roop Bhushan Kalia |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Orthopaedics
Level-6
All India Institute of Medical Sciences, Rishikesh
Virbhadra Road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
918518881790 |
| Fax |
|
| Email |
roopkalia2003@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kshitij Gupta |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Orthopaedics
Level-6
All India Institute of Medical Sciences, Rishikesh
Virbhadra Road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
918745851828 |
| Fax |
|
| Email |
kshitizg001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Road Rishikesh
Uttarkhand- 249203 |
|
|
Primary Sponsor
|
| Name |
Dr Kshitij Gupta |
| Address |
Department of Orthopaedics
Level- 6,
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarkhand- 249203 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Roop Bhushan Kalia |
Department of Orthopaedics
Level- 6,
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarkhand- 249203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kshitij Gupta |
All India Institute of Medical Sciences, Rishikesh |
Department of Orthopaedics
Level- 6
AIIMS, Rishikesh Dehradun UTTARANCHAL |
8745851828
kshitizg001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional Ethics Committee |
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 |
Callipered restricted Kinematically aligned Total Knee Arthroplasty |
Callipered Restricted Kinematically aligned Total Knee Arthroplasty performed in both the knees of the patients undergoing simultaneous bilateral total knee arthroplasty |
| Comparator Agent |
Mechanically aligned Total Knee Arthroplasty |
Mechanically aligned Total Knee Arthroplasty performed in both the knees of the patients undergoing simultaneous bilateral total knee arthroplasty |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
• All patients posted for simultaneous single staged B/L TKA
• More than one compartmental primary OA with pain interfering with their ADL
• MPTA between 5-10° varus
• KL Grade 3/4
• ASA grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
• Any patient with previous knee surgery
• Extra-articular knee deformity
• Any spine disorder which may interfere with mobilization
• Revision TKA cases
• Inflammatory Arthritis
• FFD 15° or more degrees
• Clinically uncorrectable Valgus/Varus deformity of 15° or more
• Any previous ligament surgery/reconstruction
• Previous history Septic Arthritis knee
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maximum knee flexion angle during swing phase
Maximum knee adduction moment in overall stance phase |
Pre-operatively and 6 months post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of other temporal, spatial, kinematic and kinetic gait variables |
Pre-operatively and 6 months post-operatively |
| Comparison of Patient reported outcome measures (PROMs) |
Pre-operatively and 6 months post-operatively |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
01/08/2024 |
| 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="1" Months="6" Days="0" |
|
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
|
Osteoarthritis (OA) is a debilitating condition which alters the biomechanics of the gait cycle. End stage patients need to be managed by Total Knee Arthroplasty (TKA) to alleviate pain and improve gait dynamics. There are various types of coronal alignments proposed for TKA- Mechanical alignment (MA-TKA) and restricted kinematic alignment (rKA-TKA) being one of them. While MA-TKA restores the knee into a rectus alignment, rKA-TKA aims to restore the native alignment of the original knee within the acceptable limits. The literature has shown that MA-TKA gives the patient a gait different from the normal gait pattern. The aim of the study is to ascertain if rKA-TKA is able to give better gait dynamics to the patient as compared to MA-TKA. The null hypothesis of the study is that there is no difference in the gait pattern between the two groups of TKA. This is a single centre randomised controlled trial comparing the dynamic gait biomechanics between two different types of Total Knee Arthroplasties- MA-TKA and rKA-TKA. Blinding of the patient and observer will be done. The primary outcome of the study are maximum knee flexion in swing phase and knee adduction moment in stance phase at 6 months post-operative period. The secondary objectives are comparison of other temporal, spatial, kinematic and kinetic gait variables and patient reported outcome measures at 6 months post-operative period. |