| CTRI Number |
CTRI/2020/12/030130 [Registered on: 30/12/2020] Trial Registered Prospectively |
| Last Modified On: |
14/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [WEIGHT BEARING] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the difference between weight bearing immediately 1 day after surgery versus weight bearing 12 weeks after surgery with plate/screw fixation of lower part of knee fractures, which encroach into the knee joint. |
|
Scientific Title of Study
|
To Study the effect of early versus late weight bearing after osteosynthesis of proximal tibia fractures. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Udit Jayant |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Orthopaedics, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
78, Sector 11a , Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7904466985 |
| Fax |
|
| Email |
druditjayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Chouhan |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
| Address |
Department of Orthopaedics, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
213, Sector 11, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008154 |
| Fax |
|
| Email |
drdevnim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Chouhan |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
| Address |
Department of Orthopaedics, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
213, Sector 11, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8360057338 |
| Fax |
|
| Email |
drdevnim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research PGIMER Chandigarh |
| Address |
Sector 12, Chandigarh. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Disaster Ward(Level 1), Advanced Trauma Centre.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
22 Operation Theatre (level 2), Nehru Hospital.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Advanced trauma centre Out Patient Department (Level 2), Advanced Trauma Centre.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Orthopaedics general ward (Level 5), Advanced Trauma Centre.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Emergency 22 Orthopaedics ward (level 2), Nehru Hospital.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Advanced Trauma Centre Operation Theatre (level 2), Advanced Trauma Centre.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
| Dr Udit Jayant |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |
Department of Physiotherapy and Medical Rehabilitation, Room 1025, Block 1b(level 1) , New Out Patient Department.
Chandigarh
CHANDIGARH |
917904466985
druditjayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER), CHANDIGARH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S821||Fracture of upper end of tibia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plate/Screw fixation and non weight bearing. |
All the patients planned for osteosynthesis will be randomly allocated into either of the two different rehabilitation protocols.
1. Group I, Non weight bearing protocol (Comparator) will consist of those patients that will either be non weight bearing or toe touch weight bearing (the foot or toes may touch the floor to maintain balance, but not support any weight) for the first 12 post operative weeks, as per AO (Arbeitsgemeinschaft für Osteosynthesefragen) Guidelines.
The above patients will be clinically evaluated during their follow up on 15th day, 1st month,45th day,2nd month, 3rd month and 6th month postoperatively. Functional outcome will be evaluated at minimum of 6 months postoperative follow up using clinical, radiological methods, gait evaluation and synovial fluid analysis. |
| Intervention |
Plate/Screw fixation and non weight bearing. |
All the patients planned for osteosynthesis will be randomly allocated into either of the two different rehabilitation protocols.
Group II – Early/Permissive weight bearing protocol (Intervention) will consist of patients who will be instructed to weight bear fully (as tolerated) immediately the day after surgery (post operative day 1 onwards).
The above patients will be clinically evaluated during their follow up on 15th day, 1st month,45th day, 2nd month, 3rd month and 6th month postoperatively.
Functional outcome will be evaluated at minimum of 6 months postoperative follow up using Clinical, Radiological methods, gait evaluation and synovial fluid analysis. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Closed Intra-articular proximal tibia fractures in skeletally mature patients, requiring osteosynthesis. |
|
| ExclusionCriteria |
| Details |
1. Intra-articular fracture not requiring osteosynthesis,
2. Intra-articular eminence fracture,
3. Open fractures,
4. Associated other lower limb fracture,
5. Foot deformities,
6. Limb length discrepancy >2cm,
7. Pathological fracture,
8. Skeletally immature patient,
9 Neurological injury,
10. Vascular injury,
11. Late presentation after >3weeks,
12. Previous surgery of the knee,
13. Previous septic episode,
14. Post-traumatic deformity,
15. Inflammatory arthritis,
16. Pre-existing degenerative Osteoarthritis,
17. Neuromuscular disorder involving either of lower limb. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To identify difference in gait patterns among patients with early weight bearing protocol and late weight bearing protocol by measuring lower limb symmetry indices after osteosynthesis of proximal tibia fractures.
2. To study the effect of early weight bearing protocol and late weight bearing protocol in patients after osteosynthesis of proximal tibia fracture on synovial fluid biomarkers. |
Lower limb symmetry indices and synovial fluid biomarkers to be assessed at 6 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the difference between early and late weight bearing protocol after osteosynthesis of proximal tibia fractures on
functional and radiological outcome. |
15th day, 1st month, 45th day, 2nd month, 3rd month and 6th month postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/01/2021 |
| 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="2"
Months="0"
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)?
Response - NO
|
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Brief Summary
|
BRIEF SUMMARY- Tibia plateau fractures (TPFs) are result commonly from motor vehicle accidents or fall from height .The incidence of patients with tibia plateau fractures is approximately 13.3 per 100,000 and it represents approximately 1.2% of all fractures in adults, most commonly seen in the age group of 40-60 in both the sexes. Among lower limb fractures, Tibia plateau fractures account for 2% of lower limb fractures with incidence ranging from 116/100,000 to 427/100,000. Tibia plateau fracture is a high velocity injury and often associated with high risk of complications; because of extensive soft-tissue damage swelling, compartment syndrome, neurovascular injuries, surgical site infection and deep vein thrombosis. Secondary complications in long term outcome are not rare to see, manifesting as knee instability or stiffness, angular deformities, mal-union and post-traumatic osteoarthritis. . Apart from surgical hurdles and challenges, tibia plateau fractures have significant negative impact on daily activities of patients and their economic prosperity. They are associated with disruption of physical and functional integrity of knee joint and the mental menace of being in pain and confined to bed. Since emergence of advanced imaging, implants and surgical principles and approaches, the functional outcome has improved long way. But the post operative recovery after such fracture rehabilitation after osteosynthesis is a long, tedious task for patient which involves refraining from weight- bearing for long-duration as advocated by AO guideline. . The fear of early weight bearing is associated with loss of the reduction, however the same is obviated by recent research such as that of Williamson et al. Our concern about the early weight bearing protocol is that it may lead to subjective improvement in the gait without any objective improvement in the gait parameter and on the contrary aggressive protocol may adversely affect the cartilage response at stage of healing. Same we wish to prove and disprove with our proposed study/research protocol.
NULL HYPOTHESIS: There is no difference between Early-weight bearing protocol and Non-weight bearing protocol on the outcome after osteosynthesis of proximal tibia fractures. |