| CTRI Number |
CTRI/2024/11/077019 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Anterior cruciate ligament reconstruction surgery outcomes with and without the use of antibiotic solution during graft preparation. |
|
Scientific Title of Study
|
Assessing the outcomes of anterior cruciate ligament reconstruction with or without the use of antibiotic solution in graft preparation: A Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Gourab |
| Designation |
Junior resident |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Department of Orthopaedics, RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7903517289 |
| Fax |
|
| Email |
kgourabchakraborty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Govind Kumar Gupta |
| Designation |
Additional Professor, HOD orthopaedics |
| Affiliation |
Rajendra Institute of Medical Sciences , Ranchi |
| Address |
Department of Orthopaedics , Rajendra Institute of Medical Sciences , Bariatu , Ranchi
Department of Orthopaedics , RIMS , Ranchi , Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Govind Kumar Gupta |
| Designation |
Additional Professor, Head of Department |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Department of Orthopaedics, RIMS Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India. Pincode-834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Orthopaedics , Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, Pin-834009 |
| 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 Kumar Gourab |
Rajendra Institute of Medical Sciences |
Department of Orthopaedics, operation theatre, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND |
7903517289
kgourabchakraborty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC , RIMS , Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline solution (without antibiotics) during ACL graft preparation . |
Graft used in this group is soaked in normal saline solution(without antibiotics) for 10-15 mins. |
| Intervention |
Vancomycin Antibiotic solution during ACL graft preparation. |
Graft is placed in vancomycin solution ( 500 mg of vancomycin powder in 100 mL normal saline) for 10mins to 15 mins during the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Individuals diagnosed with a complete rupture of the ACL who are indicated for surgical reconstruction
b) patients willing to provide informed consent to participate in the study
c) patients with no history of no prior ACL reconstruction surgery
d) patients without significant comorbidities or medical conditions |
|
| ExclusionCriteria |
| Details |
a) patients with concurrent injuries involving multiple major ligaments of the knee
b) patients younger than 18 years or older than 65 years
c) patients with previous history of ACL reconstruction of the same knee
d) patients with active systemic or local infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the infection rates in patients undergoing ACL reconstruction surgery |
Postoperative day(POD)- 2,6,10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To evaluate the incidence of graft failure(graft rupture or re-tear) between the two study groups
b) to explore whether patients characteristics such as age, sex, BMI and previous medical history influence the clinical outcomes and infection rates in both study groups |
1 month and 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
27/11/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Aim of the study is to evaluate and compare the outcomes of ACL reconstruction procedures specifically examining the use of antibiotic solutions during graft preparation. Study population includes patients with ACL tear admitted in orthopaedic department of RIMS Ranchi.Computer generated random numbers will be used for randomisation and simple randomisation will be used to allocate two groups in equal halves. For one group, antibiotic soaked grafts will be used during ACL reconstruction surgery and in other group, no such solution will be used. Follow-up will be done on post operative day- 2,6 and 10 to compare the infection rates between the two groups. Secondary follow-up will be done 1 month and 3 months after surgery to compare graft failure between the two groups. |