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CTRI Number  CTRI/2019/07/020426 [Registered on: 29/07/2019] Trial Registered Prospectively
Last Modified On: 29/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see role of knee barce after anterior cruciate ligament surgery 
Scientific Title of Study   Comparison of Functional Outcome with Knee Brace and without Knee Brace Physiotherapy After Anterior Cruciate Ligament Reconstruction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ravi Gupta 
Designation  Professor 
Affiliation   
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121502  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ravi Gupta 
Designation  Professor 
Affiliation   
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121502  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keshav Jindal 
Designation  Postgraduate Resident 
Affiliation   
Address  Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  881409429  
Fax    
Email  drkeshavjindal@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College And Hospital, Chandigarh 
 
Primary Sponsor  
Name  Government Medical College And Hospital 
Address  Sector 32B chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Keshav Jindal  Government Medical College and Hospital, Chandigarh  Room No. 3108 Orthopaedic Surgery OPD B Block, Gmch 32, Chandigarh
Chandigarh
CHANDIGARH 
08814094929

drkeshavjindal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. ACL injury during sports activity.
2. Age between 18-40 years.
3. All sexes. 
 
ExclusionCriteria 
Details  1. Previously operated upon the same knee.
2. Previous infective pathology of the same knee.
3. Any other ligament injury in ipsilateral/ contralateral knee presently or in the past.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of knee bracing and non-knee bracing during post-operative
rehabilitation on functional outcome in patients undergoing ACL reconstruction. 
1 year and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To see the functional outcome in the respect of return to sports, mechanical stability and Lysholm score  1 year 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/07/2019 
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)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The anterior cruciate ligament  (ACL) helps in controlling motion at the knee joint in the transverse plane. It provides passive stability to the joint by guiding it during internal and external rotation and also during abduction and adduction movements. In sports activities, injury to ACL is common. ACL injury can occur in various ways like  changing direction rapidly, stopping suddenly, landing from a jump incorrectly, slowing down while running or direct contact such as a football tackle. Healing of ACL does not occur on its own, therefore many methods have been designed to treat the ACL-injured knee. The current gold standard treatment for a skeletally mature patient is an ACL reconstruction with a tendon graft. Common grafts that can be used for ACL reconstruction are patellar tendon, hamstring tendon, and quadriceps tendons. Rehabilitation following Anterior Cruciate Ligament Reconstruction (ACLR) is an important  part of a full recovery. There are 3  phases of graft healing-  Early  graft  healing  phase (0–4 weeks)  in  which  there  is  graft  necrosis,  hypocellularity  and  overall  collagen  structure  is maintained.  Proliferative  phase (4–12 weeks)  in which there is cellular repopulation and  revascularization. Ligamentization phase (12 weeks–≥1 year) -Graft approaches normal ACL in this phase. The primary aim is to withstand first 6-9 weeks with a graft that remains intact and tight with near full knee extension and minimum swelling. Following ACL surgery, many different rehabilitation options have been explored but no clear consensus on the best rehabilitation strategy has been reached. Some surgeons recommended immobilization for 6-8 weeks with brace and subsequent use of crutches for next 3-4 month. Some surgeons advised against the use of quadriceps immediately in the post-operative period to  protect  the  reconstructed  knee.Shelbourne  and  Nitz  gave  the  system  of  aggressive accelerated  rehabilitation. They  concluded  that  patients  who  were  managed  with  this aggressive rehabilitation protocol had better functional outcome. After the work of Shelbourne and  Nitz,  rehabilitation  protocols  focused  more  on  immediate  post-operative  mobilization, muscle strengthening, full weight bearing and full passive extension. The  application  of  post-operative  bracing  of  the  knee  after  ACL reconstruction is a controversial topic. Palm et al concluded that patients who were given brace post operatively experienced better postural control/stability as compared to patients who were not given knee brace. It  has  also  been  observed  that  knee  brace  reduces  pain  and  early  post-operative complications and offer increased protection to implanted graft. On the contrary, it has been observed that knee bracing causes joint stiffness, collagen degeneration and also cause muscle atrophy. The  other  disadvantages  of  brace  include  decrease  in  patient’s  perception  of  maximal performance, increase in fatigability during exercise and daily activities, discomfort and additional cost . Recently there are reports that have shown that non bracing has similar functional outcome after ACL reconstruction as compared to bracing. Due to scant literature of high-level evidence comparison studies, the issue of use /non-use of brace is still unresolved. Further, there is no study from India which has compared the use of bracing with non-bracing. The purpose of this study is to evaluate the effects of bracing during post-operative rehabilitation on functional outcome in patients undergoing ACL reconstruction.
 
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