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CTRI Number  CTRI/2020/12/030036 [Registered on: 24/12/2020] Trial Registered Prospectively
Last Modified On: 23/12/2020
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 walking immediately 1 day after surgery versus walking 12 weeks after plate/screw fixation of lower part of knee fractures. 
Scientific Title of Study   To study the effect of early versus late weight bearing after osteosynthesis of proximal tibia fractures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
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- 160012, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008154  
Fax    
Email  drdevnim@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- 160012, India


CHANDIGARH
160012
India 
Phone  7087008154  
Fax    
Email  drdevnim@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Udit Jayant 
Designation  Junior Resident 
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.

Chandigarh
CHANDIGARH
160012
India 
Phone  7904466985  
Fax    
Email  druditjayant@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  Post Graduate Institute of Medical Education and Research PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
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.  Advanced Trauma Centre Operation Theatre (level 3), Advanced Trauma Centre. Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 		 7904466985

druditjayant@gmail.com 
Dr Udit Jayant  Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.  Main Theatre (level 4), Nehru Hospital. Chandigarh
Chandigarh
CHANDIGARH 		 7904466985

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
CHANDIGARH 		 7904466985

druditjyant@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
CHANDIGARH 		 7904466985

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
CHANDIGARH 		 7904466985

druditjayant@gmail.com 
Dr Udit Jayant  Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.  Disaster Ward(Level 1), Advanced Trauma Centre. Chandigarh
Chandigarh
CHANDIGARH 		 7904466985

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
CHANDIGARH 		 7904466985

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
CHANDIGARH 		 7904466985

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, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S821||Fracture of upper end of tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Screw/plate internal fixation of tibia plateau fracture and early weight bearing as tolerated, from post operative day-1 onwards.  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. 
Comparator Agent  Screw/plate internal fixation of tibia plateau fracture and late weight bearing till 12 weeks post operatively.  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. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Skeletally mature, closed, intra-articular tibia plateau fracture without distal neurovascular deficit. 
 
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. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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. 		 Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively. 
 
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. 		 Functional outcome at 6 months. Radiological outcome immediately after surgery and at 6 months post-operatively. 
 
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   N/A 
Date of First Enrollment (India)   01/01/2021 
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="1"
Months="6"
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
Brief Summary  

Proximal tibia fractures are one of the commonest bony injuries associated with post- traumatic osteoarthritis. Past few decades have witnessed advances in imaging modalities, surgical concepts, planning and biomechanically better implants, and so is the shift in the post-operative rehabilitation protocols, from late to early-weight bearing. While latest studies indicate no difference between the two regimens, the objectivity in the final functional outcome is still elusive.

 
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