| CTRI Number |
CTRI/2024/09/074287 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Effect of Proximal Fibular Osteotomy in Osteoarthritis of Knee |
|
Scientific Title of Study
|
A Comparative study of Conservative treatment versus Proximal Fibular Osteotomy in Early Osteoarthritis of Knee |
| 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 PANDYA JAY MUKESHBHAI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Department of Orthopaedics, AVBRH Wardha |
| Address |
Department of orthopaedics, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha - 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8200630651 |
| Fax |
|
| Email |
pandyajay2361997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nareshkumar Satyanarayan Dhaniwala |
| Designation |
Professor |
| Affiliation |
Dr Nareshkumar Dhaniwala, Professor, Department of Orthopaedics, AVBRH Wardha |
| Address |
Department of Orthopaedics, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha - 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422188450 |
| Fax |
|
| Email |
nsdhaniwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PANDYA JAY MUKESHBHAI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Department of Orthopaedics, AVBRH Wardha |
| Address |
Department of orthopaedics, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha - 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8200630651 |
| Fax |
|
| Email |
pandyajay2361997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
| Address |
Sawangi (Meghe), Wardha - 442107, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 PANDYA JAY MUKESHBHAI |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Department of orthopaedics, JNMC, Sawangi (Meghe), Wardha - 442107, Maharashtra, India
Wardha
MAHARASHTRA |
8200630651
pandyajay2361997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Datta Meghe Institute of Higher Education and Research Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M15-M19||Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Medications and Physiotherapy |
Tab Aceclofenac 100mg with Paracetamol 325mg for 3 days followed by Tab Paracetamol 650mg 8 hourly for 5 days and then sos
Tab Calcium 500mg twice daily for 6 weeks
Sachet Vitamin D3 6lakh IU Once a week for 8 weeks
Hot Fomentation
Knee Bending Exercises
Quadriceps Strengthening Exercises
Lateral Wedge in the shoe and Heel
Lifestyle modifications |
| Intervention |
Proximal Fiblar Osteotomy |
A segment of 2cm of fibula will be removed between 8 to 12 cm away from head of fibula on the affected side under spinal anaesthesia and patient will be mobilized from the day after surgery |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between Age 40 years to 70years
Patients of Early Primary Osteoarthritis (Kellgren and Lawrence Grade 1,2,3) of Knee with Genu Varus Deformity
Patients who are willing to take part in study after informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with Secondary Osteoarthritis of Knee
Patients with Advanced Osteoarthritis (Kellgren and Lawrence Grade 4) of Knee
Patients with Severe Co-morbidities
Patients Unwilling for the Study
Patients having Infective, Inflammatory and Post Traumatic Arthritis of Knee
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Do a Comparative Study of Conservative Treatment versus Proximal Fibular Osteotomy in Early Osteoarthritis of Knee |
3 months, 6 months, 9 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Do a Comparative Study of Conservative Treatment versus Proximal Fibular Osteotomy in Early Osteoarthritis of Knee |
3 months
6 months
9 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pandyajay2361997@gmail.com].
- For how long will this data be available start date provided 08-03-2023 and end date provided 01-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoarthritis is a prevalent and debilitating ailment worldwide, of which knee osteoarthritis constitutes a significant percentage and presents with symptoms that impair quality of life,including pain, stiffness, dysfunction and even deformity. In this study, Patients of early osteoarthritis will be divided in the 2 groups. One group will be given conservative management in the form of oral medications, physiotherapy and lifestyle modifications, Second group will recieve operative management in the form of proximal fibular osteotomy. Results of both the managements will be compared in the form of reduction of pain, improved knee joint range of movement and radiological evaluation. |