| CTRI Number |
CTRI/2024/02/063386 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Removed Tissues in Total Hip and Knee Replacement Surgeries
|
|
Scientific Title of Study
|
Examination of primary total hip and knee arthroplasty tissues
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arunava Kumar Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Orthopaedics
Room number 4
OPD complex, Kasturba Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8811026188 |
| Fax |
|
| Email |
arunavabhuyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran K V Acharya |
| Designation |
Prof and HOU |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Orthopaedics
Room number 4
OPD complex, Kasturba Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
Kiran.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran K V Acharya |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Orthopaedics
Room number 4
OPD complex, Kasturba Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
Kiran.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal. |
|
|
Primary Sponsor
|
| Name |
Dr Arunava Kumar Bhuyan |
| Address |
Room number 4
Kasturba Hospital OPD Complex
Manipal - 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Shyamsunder Bhat |
Department of Orthopaedics, KMCH MAHE Manipal |
Room no 4, Kasturba Hospital OPD Complex, Manipal
Udupi
KARNATAKA |
9480486075
shyambhat.n@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
No known hip/knee pathology/infection preop apart from diagnosis. |
|
| ExclusionCriteria |
| Details |
Revision arthroplasty surgeries |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Histological and microbiological sample reports routinely sent intraoperatively |
Histological and microbiological sample reports routinely sent intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significance of sending these routine investigations |
End of study |
| If not significant, overall economic burden of the same |
End of study |
|
|
Target Sample Size
|
Total Sample Size="1394"
Sample Size from India="1394"
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)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission shall be taken from Medical Superintendent of KH and Orthopedic Surgeons in the Department of Orthopaedics, KMC Manipal to use the medical records of their patients. All demographic data collected shall be kept anonymous. Samples will be selected from hospital records and selection of samples will be done based on above mentioned inclusion and exclusion criteria. Patient data will be collected from EMR and MRD. Pre-operative tests reports and intra operative histopathological and microbiological test results will be collected. Patient records will be utilized to analyse whether the patient underwent any change in antibiotic therapy based on microbiological reports and the course of the patients follow up and progress will be followed for atleast 1 year through hospital records in EMR to ascertain the outcome of the post operative period and whether the patient developed PJI at any time post op. A negative intraoperative culture report with post operative PJI will be considered as a insignificant result. The total number of insignificant studies will be multiplied by the mean cost of the microbiologcal analysis(over the past 10 years) to obain the approximate financial burden of microbiological analysis to the patients over the past 10 years in Kasturba Hospital. Histological reports will be analysed and grouped whether they were concordant (similar), discordant (different but not warranting change in treatment plan) or discrepant (different and warranting change in treatment plan) as compared to the preoperative clinicoradiological diagnosis of the Orthopedic surgeon. Every concordant match will be considered as a non-significant result and the total non-significant results will be tabulated and multiplied by the mean cost of histological analysis (over the past 10 years) to obtain the approximate financial burden of histological analysis to the patients over the past 10 years in Kasturba Hospital. All these data collected will be tabulated in excel |