| CTRI Number |
CTRI/2019/02/017681 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Knee pain due to wear and tear - comparison of two treatment options |
|
Scientific Title of Study
|
Knee Joint Distraction with and without Arthroscopic Debridement in Osteoarthritis of the Knee in the Young – A Prospective Randomized Superiority Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koushik Narayan Subramanyam |
| Designation |
Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No. 142, Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram.
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
|
| Fax |
|
| Email |
drkoushik@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Koushik Narayan Subramanyam |
| Designation |
Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No. 142, Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram.
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
|
| Fax |
|
| Email |
drkoushik@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gupta Dinesh Harigovind |
| Designation |
Junior Resident |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No. 142, Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram.
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
|
| Fax |
|
| Email |
dinesh25gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram |
| Address |
Room No. 142, Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Koushik Narayan Subramanyam |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
Room No 142, Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram
Anantapur
ANDHRA PRADESH |
9491629620
drkoushik@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Scientific Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthroscopic debridement followed by knee joint distraction |
Patients will be taken for arthroscopic debridement and 6 weeks later for Ilizarov assisted knee joint distraction of the knee joint for 5mm which will be maintained for a period of 6 weeks. |
| Comparator Agent |
Knee joint distraction |
Ilizarov assisted knee joint distraction of the knee joint for 5mm which will be maintained for a period of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Kellegren and Lawrence grade 3 and 4
2. Intact knee ligaments by clinical tests
3. At least 120 degrees of knee flexion
4. Body Mass Index less than 35
|
|
| ExclusionCriteria |
| Details |
1. Contraindications to MRI
2. Inflammatory arthritis
3. Post traumatic arthritis
4. Complete absence of joint space on radiographs
5. History of past surgeries in the knee concerned
6. Present or past infection in the knee concerned
7. Any intervention to the knee concerned like injection of steroids
8. Coronal plane deformity (varus / valgus) more than 10 degrees
9. Fixed flexion deformity more than 10 degrees
10. Any evidence of knee instability
11. Primary patellofemoral arthritis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee functional scores |
Pretreatment and 3.6 and 12 months from treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiological parameters (Joint space width) |
Pretreatment and 12 months from intervention |
| MRI parameters (cartilage thickness) |
Pretreatment and 12 months from intervention |
| Quality of life parameters |
Pretreatment and 12 months from intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Once study is complete, we will submit to scientific journals interested in the subject. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Knee joint distraction is coming up as a promising biological method of treatment of osteoarthritis of the knee in the young. Prospective trials on the subject are not many. Further more it is not known if addition of arthroscopic debridement will make the outcome superior. Our prospective trial aims at measuring these parameters. A total of 40 patients will be recruited. 20 of them will be randomly allocated to knee joint distraction alone. The other 20 will be allotted to arthroscopic debridement followed by knee joint distraction. Clinical, radopgraphical, MRI and quality of life parameters will be assessed and compared to see the improvement from baseline parameters and further if addition of arthroscopic debridement makes the outcome superior. Informed consent will be obtained from all the patients involved in the study. |