| CTRI Number |
CTRI/2015/06/005841 [Registered on: 02/06/2015] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Repair and Regeneration of Knee cartilage |
|
Scientific Title of Study
|
Role of Autologous Chondrocyte Implantation in Chondral Defects of Knee Joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bulagonda Eswarappa Pradeep |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Biosciences,
Sri Sathya Sai Institute of Higher Learning,
Vidyagiri, Prasanthinilayam,
Puttaparthi, Andhra Pradesh,
India
Vidyagiri, Prasanthinilayam,
Puttaparthi, Andhra Pradesh,
India
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8008739138 |
| Fax |
08555-286919 |
| Email |
bepradeep@sssihl.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash kanchandani |
| Designation |
Additional Senior Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences, Prasanthigram |
| Address |
Head,
Department of Orthopaedics,
Sri Sathya Sai Institute of Higher Medical Sciences,
Prasanthigram, Andhra Pradesh, India
Sri Sathya Sai Institute of Higher Medical Sciences,
Prasanthigram, Andhra Pradesh, India
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9652392745 |
| Fax |
08555-287544 |
| Email |
drprakashk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash kanchandani |
| Designation |
Additional Senior Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences, Prasanthigram |
| Address |
Head,
Department of Orthopaedics,
Sri Sathya Sai Institute of Higher Medical Sciences,
Prasanthigram, Andhra Pradesh, India
Sri Sathya Sai Institute of Higher Medical Sciences,
Prasanthigram, Andhra Pradesh, India
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9652392745 |
| Fax |
08555-287544 |
| Email |
drprakashk@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Learning, vidyagiri, prasanthi nilayam. 515134, A.P. India |
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Vidyagiri, Prasanthinilayam,
Puttaparthi, Andhra Pradesh,
India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sathya Sai Institute of Higher Medical Sciences prasanthigram |
Prasanthigram
Puttaparthi, Andhra Pradesh,
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bulagonda Eswarappa Pradeep |
Sri Sathya Sai institute of Higher Medical Sciences |
Chondrocyte Cell culture lab,
Department of Orthopaedics,
Sri Sathya Sai Institute of Higher Medical Sciences,
Prasanthigram, Andhra Pradesh, India
Anantapur
ANDHRA PRADESH |
8008739138
08555-286919
bepradeep@sssihl.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S870||Crushing injury of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthroscopy |
Arthroscopic collection of cartilage from the non weight bearing region of the knee |
| Intervention |
Open Surgery |
Surgical implantation of the Invitro cultured Chondrocytes in the osteochondral defect of the knee |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Femoral chondral defects in the age group of 18 to 50. |
|
| ExclusionCriteria |
| Details |
a)Patients below the age of 18 years and above the age of 50 years.
b)Co-morbidities such as inflammatory arthritis and metabolic and endocrinal diseases.
c)Patients unfit for surgical procedures from anaesthesia point of view.
d)Patients with joint deformities in lower extremity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
.Improvement in pain scores
.Improvement in range of motion of knee.
. reaching the pre-injury level of activities.
. prevention of the progression of the chondral defect to Osteoarthritis of knee. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. The patient may be able to participate in active sports and other activities
. the procedure would help in the healing of the cartilage which is almost similar to hyaline cartilage present in non-injured knee. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2015 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study has been terminated due to lack of funding.
Articular (hyaline) cartilage, which is composed mainly of water and a collagenous extracellular matrix, provides a smooth and resilient surface at the ends of bones, allowing virtually frictionless movement within the knee joint. It also acts as a shock absorber, cushioning the bone from forces of more than five times the body’s weight. The cellular component of hyaline cartilage is the chondrocyte, which is responsible for the production and maintenance of the matrix. Cartilage lacks blood and nerve supplies, and it has a limited potential for self-repair. Hence, Autologous Chondrocyte Implantation (ACI) helps in regeneration of the chondral defects.
Cartilage damage in the knee can be caused directly by injury, often as a result of sporting activity, or spontaneously (a condition called osteochondritis dissecans). Loss of cartilage alone is referred to as chondral damage, whereas loss of bone and cartilage is known as osteochondral damage. Symptoms associated with the loss of hyaline cartilage include knee pain, knee swelling, Locking of knee and giving way of the knee joint. Ultimately, mechanical damage to the joint surface can lead progression of the chondral defect and eventually to osteoarthritis, which will warrant a total knee replacement in future. Following ACI procedure, the patient may lead a normal active lifestyle and participate in sporting activities. |