| CTRI Number |
CTRI/2019/01/016821 [Registered on: 01/01/2019] Trial Registered Prospectively |
| Last Modified On: |
02/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of conventional hand therapy and assistive device in the rehabilitation of flexor tendon injuries |
|
Scientific Title of Study
|
A randomized control trial comparing the functional outcomes in patients with post tendon repair mobilized by conventional hand therapy versus assistive device |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkata Vinay Atluri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Meical college Manipal |
| Address |
Department of Orthopedics
Kasturba medical college
Tiger Cir Rd, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259535379 |
| Fax |
|
| Email |
Vinay10200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwath Acharya |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical college Manipal |
| Address |
Department of Orthopaedics
Kasturba medical college
Tiger Cir Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8217736961 |
| Fax |
|
| Email |
anmacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkata Vinay Atluri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Meical college Manipal |
| Address |
Department of Orthopaedics
Kasturba medical college
Tiger Cir Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7259535379 |
| Fax |
|
| Email |
Vinay10200@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college
Department of Orthopaedics
Tiger Cir Rd, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Orthopaedics |
| Address |
Kasturba Medical College
Department of orthopaedics
Tiger Cir Rd, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Venkata Vinay Atluri |
Kasturba Hopsital |
Department of Orthopaedics
Room No:4
Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7259535379
vinay10200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M663||Spontaneous rupture of flexor tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobilization |
Assistive device
Intervention will be provided for a period of 3 months and 2 sessions daily one in the morning and one in the evening each session will be for a period of 60 minutes |
| Intervention |
Mobilization |
Conventional hand therapy
Intervention will be provided for a period of 3 months and 2 sessions daily one in the morning and one in the evening each session will be for a period of 60 minutes |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Patients with zone II to zone V flexor tendon injuries who have been operated by early primary tendon repair |
|
| ExclusionCriteria |
| Details |
-Patients with associated fractures, nerve and vascular injury along with tendon injuries of the hand which may affect the rehabilitation.
-Patients with tendon injuries of hand with different zones in the same hand
-Patients with combined flexor and extensor tendon injuries of hand.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total active flexion and Total active motion (Strictland criteria and Tang criteria) |
Post operatively at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grip strength and pinch strength |
At 6 months and 12 months post intervention |
| Quick dash score |
Postop at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
07/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised , open labelled, parallel group, active controlled, single centre trail comparing the comparing the functional outcomes in patients with post tendon repair mobilized by conventional hand therapy and assistive device for 1.6 years in 120 patients in one centre in India. The primary outcome measurements will be functional outcomes: TAF and TAM (Strickland criteria and Tang criteria) Post op at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention. The secondary outcomes will be grip strength and pinch strength at 6 months and 12 months post intervention and Quick dash score Post op at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention. |