| CTRI Number |
CTRI/2024/02/062451 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Effect of a Blood Product named Platelet Rich Plasma in Shoulder Tendon Injuries . |
|
Scientific Title of Study
|
A Randomized Controlled Study Evaluating Effect of Platelet-Rich Plasma in Rotator Cuff Injuries. |
| 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 Vinit Rathod |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Orthopaedics Department , Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha , Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7066913921 |
| Fax |
|
| Email |
rathodvinit999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Orthopaedics Department , Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha , Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765404068 |
| Fax |
|
| Email |
drsandeepshrivastava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Orthopaedics Department , Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha , Maharashtra.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765404068 |
| Fax |
|
| Email |
drsandeepshrivastava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics , DMIHER , Sawangi Meghe , Wardha |
|
|
Primary Sponsor
|
| Name |
DMIHER |
| Address |
Datta Meghe Institute of Higher Education and Research , Sawangi ( Meghe ) |
| Type of Sponsor |
Other [DEEMED TO BE UNIVERSITY ] |
|
|
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 Vinit Rathod |
Datta Meghe Institute of Higher Education and Research |
Department of Orthopaedics , Sawangi Meghe , Wardha , Maharashtra
Wardha
MAHARASHTRA |
7066913921
rathodvinit999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthroscopic Rotator cuff repair |
Patients with Diagnosed Rotator cuff tear will be treated with Arthroscopic Rotator Cuff repair and the outcome will be assessed by various subjective and objective scoring systems over a period of 9 months |
| Comparator Agent |
Platelet Rich Plasma infiltration in Arthroscopic Rotator cuff repair |
Patients with Diagnosed Rotator cuff tear will be treated with Platelet Rich Plasma infiltration during Arthroscopic Rotator Cuff repair and the outcome will be assessed by various subjective and objective scoring systems over a period of 9 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years,
Patients of Partial or Complete Rotator Cuff Tear ,
Primary , Degenerative or Traumatic Rotator Cuff Injuries |
|
| ExclusionCriteria |
| Details |
History of shoulder fracture involving humeral head on affected side
Previous Operative Intervention of the Ipsilateral Shoulder
Rotator Cuff Tear associated with other pathologies
Previous infection in the same shoulder
Uncontrolled Diabetes
Patients with Bleeding tendencies and |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study , there might be early relief after PRP infiltration in Arthroscopic Rotator Cuff Repair compared to those treated without PRP infiltration . |
Pre operatively , post operative management day 0 , 3 months post operative management . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MRI assessment of Rotator cuff |
9 months post operative management |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| 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="3"
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
|
Patients with Shoulder Pain will be subjected to Clinical and Radiological evauation .40 Patients with diagnosed Rotator Cuff tear will be taken up for study . They will undergo Arthroscopic Rotator cuff repair with and without PRP infiltration on a random basis .40 patients will be divided into 2 groups Group A : Fibrin Clot Implantation in Shoulder Joint while doing Arthroscopy Group B : Only Arthroscopic Repair done (Control Group). Assessment will be done Pre-operatively , day 0 ; follow up will be taken on 3 months, 6 months and 9 months. |