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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
Intervention / Comparator Agent
|
|
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. |