| CTRI Number |
CTRI/2024/05/067049 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring Platelet-Rich Plasma Therapy for Orthopedic Conditions: A Comprehensive Analysis |
|
Scientific Title of Study
|
A Study Evaluating Platelet-Rich Plasma in Orthopedics Disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Shrivastava |
| Designation |
Director Professor |
| Affiliation |
|
| Address |
Department of Orthopaedics Acharya Vinoba Bhave Rural Hospital Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404068 |
| Fax |
|
| Email |
ceohospitals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital Sawangi wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Shrivastava |
| Address |
DMIHER JNMC Campus Sawangi Wardha |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aditya Pundkar |
DMIHER JNMC Campus Sawangi Wardha |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Shrivastava |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopaedics Datta Megha Institute of Higher Education and Research Center Sawangi Wardha
Wardha
MAHARASHTRA |
09765404068
ceohospitals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Platelet-rich plasma infiltration |
Through Direct or Indirect delivery/application of PRP ( both fluid /gels) under Ultrasound/IITV |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Fractures and its Impairments
Wounds & Suturing.
Tendinopathies and tendon injuries
Bone defects
Osteoarthritis
Osteomyelitis
Regeneration of acute and chronic Ischemia of the Limb including progressive necrosis or Gangrenes
|
|
| ExclusionCriteria |
| Details |
High Risk Patients with low Haemoglobin, bleeding disorders, abnormal haematocrit counts particularly subnormal platelet count |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test the long-term Safety and Efficacy of PRP in Orthopaedic Practice, developing it as a therapeutic intervention |
10 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of Orthopaedic disorders |
10 years |
|
|
Target Sample Size
|
Total Sample Size="1250"
Sample Size from India="1250"
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 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="10"
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
|
To study the role of PRP in terms of
long-term safety and efficacy in the following orthopedic disorders:
A.
Traumatic: Fracture Impairments, Wound &
Skin Healing, and Tendon Healing.
B.
Non-traumatic: Osteomyelitis, bone defects,
tendinopathies and Osteoarthritis.
C.
Regeneration of Skin, Muscles, Cartlidge, Tendons and Bone in
Ischemic conditions.
|