| CTRI Number |
CTRI/2021/02/031310 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Local Use of Antibiotic Powder during total knee replacement |
|
Scientific Title of Study
|
Effect of intrawound vancomycin in prevention of surgical site infection/periprosthetic joint infection after primary total knee arthroplasty: prospective RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Apte |
| Designation |
Research Fellow |
| Affiliation |
Sunshine Hospitals |
| Address |
Department of Orthopaedic Surgery, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana 500035
Department of Orthopaedic Surgery, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana 500035
Hyderabad
TELANGANA
500035
India |
| Phone |
9652111991 |
| Fax |
|
| Email |
dradityaapte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praharsha Mulpur |
| Designation |
Senior Registrar |
| Affiliation |
Sunshine Hospitals |
| Address |
Department of Orthopaedic Surgery, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana
PG Road, opposite Parsi Dharamsala, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad, Telangana 500003
Hyderabad
TELANGANA
500035
India |
| Phone |
9652111991 |
| Fax |
|
| Email |
praharshamulpur9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praharsha Mulpur |
| Designation |
Senior Registrar |
| Affiliation |
Sunshine Hospitals |
| Address |
Department of Orthopaedic Surgery, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana
PG Road, opposite Parsi Dharamsala, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad, Telangana 500003
Hyderabad
TELANGANA
500035
India |
| Phone |
09652111991 |
| Fax |
|
| Email |
praharshamulpur9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedic Surgery, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana 500035 |
|
|
Primary Sponsor
|
| Name |
Sunshine Hospital |
| Address |
PG Road, opposite Parsi Dharamsala, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad, Telangana 500003 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Praharsha Mulpur |
Sunshine Hospitals, Gachibowli |
Department of orthopaedic surgery, Room 133, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana 500035
Hyderabad
TELANGANA |
09652111991
praharshamulpur9@gmail.com |
| Aditya Apte |
Sunshine Hospitals, Secunderabad |
Department of orthopaedics, Room No. 6, Sunshine Hospitals, PG Road, opposite Parsi Dharamsala, Paradise, Sappu Bagh Apaprtment, Jogani, Ramgopalpet, Secunderabad, Telangana 500003
Hyderabad
TELANGANA |
8452045278
dradityaapte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sunshine Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra-wound Vancomycin Group |
Patients in this group will undergo primary total knee replacement and will receive
1. Pre-op standard antibiotic (Single-dose pre-operative Intravenous Cefuroxime 1.5g, Single-dose post-operative Intravenous Cefuroxime 1.5g)
+ 2. Intra-articular Vancomycin (STAT DOSE, Dose: 2g, Route: Local application of vancomycin powder, before arthrotomy closure and closure of the knee joint |
| Comparator Agent |
Standard Antibiotic Group: Single Dose pre-operative IV Cefuroxime |
Primary total knee arthroplasty with standard single dose of pre-operative antibiotic (Route-Intravenous, Cefuroxime 1.5g) only, with one single post-operative dose of intravenous cefuroxime 1.5g before discharge. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing primary total knee arthroplasty for osteoarthritis of the knee joint |
|
| ExclusionCriteria |
| Details |
Inflammatory arthritis
Post-traumatic arthritis
Previous knee surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute infection rate: Incidence of Surgical Site Infections (SSI) or Periprosthetic Joint Infection (PJI) |
Assessment and documentation of surgical site infection (SSI) or Peri-prosthetic Joint Infection (PJI) at 2 weeks, 4 weeks, 3 months, 6 months, 1 year after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Long term Infection rate |
1 year |
| Functional outcomes using WOMAC score |
3 months, 6 months, 1 year |
| Functional outcome assessed by Oxford Knee Score (OKS) |
3 months, 6 months, 1 year |
| Functional outcomes assessment by Patient reported outcome measure (PROM) by Forgotten Joint Score (FJS) |
3 months, 6 months, 1 year |
| Quality of Life Indicator (EQ-5D) |
3 months, 6 months, 1 year |
| Correlation of patient factors with infection rates |
6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
01/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infection is a dreaded complication of total joint replacement surgery.
Antibiotic protocols vary widely across institutions and countries in the prevention of peri-prosthetic joint infections after total knee replacement surgery.
Several studies in the western literature have shown intra-wound/ intra-articular antibiotic powder to reduce the infection rates after primary total knee arthroplasty. However, there are no randomised control trials on this subject. Most studies are inadequately powered, or retrospective analyses.
Intra-articular vancomycin has been proven to be safe without systemic effects of toxicity.
Primary purpose: The aim of this study is to evaluate efficacy of Local intra-articular/intra-wound vancomycin powder on infection rates after primary total knee arthroplasty.
Null Hypothesis: There is no difference in infection rates after primary total knee arthroplasty between patients receiving standard intravenous single dose antibiotic (IV Cefuroxime 1.5g) versus those receiving ccefuroxime + intra-articular vancomycin powder before closure of joint.
The primary outcome is to assess acute infection rate at 3 months (Early infections) after primary TKR. |