| CTRI Number |
CTRI/2024/07/070405 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Modified needle technique for the treatment of Dupuytren’s disease and assessing its functional outcome |
|
Scientific Title of Study
|
Functional outcome of modified percutaneous needle aponeurotomy for Dupuytren’s disease |
| 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 Navaneeth P K |
| Designation |
Senior resident |
| Affiliation |
KMC Manipal, MAHE Manipal |
| Address |
Hand surgery department
KMC Manipal
Tiger Circle Road, Madhav Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9048375894 |
| Fax |
|
| Email |
navaneeth.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil K Bhat |
| Designation |
Professor and HOD, Associate Dean |
| Affiliation |
KMC Manipal, MAHE Manipal |
| Address |
Hand surgery department
KMC Manipal
Tiger Circle Road, Madhav Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9008419336 |
| Fax |
|
| Email |
anil.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil K Bhat |
| Designation |
Professor and HOD, Associate Dean |
| Affiliation |
KMC Manipal, MAHE Manipal |
| Address |
Hand surgery department
KMC Manipal
Tiger Circle Road, Madhav Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9008419336 |
| Fax |
|
| Email |
anil.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Navaneeth P K |
| Address |
Room no:509, Amartyasen hostel
KMC Manipal
Tiger Circle Road, Madhav Nagar
Manipal, Karnataka, 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Navaneeth P K |
KMC Manipal, MAHE Manipal |
Kasturba Medical College Manipal
Tiger Circle Road, Madhav Nagar
Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
9048375894
navaneeth.kmcmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M720||Palmar fascial fibromatosis [Dupuytren], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Symptomatic MCP joint contracture with a palpable cord (not beyond stage 2 Tubiana), 2)PIP joint contracture less than 15 degrees, 3)Compliant patient
|
|
| ExclusionCriteria |
| Details |
1)Severe PIP joint contracture, 2)Skin shortage, scarring , tight skin, 3)Aggressive systemic disease, 4)Non-compliant patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quick DASH Score, URAM Scale and range of motion of the affected fingers |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will include a safety assessment, as judged by incidence rate and severity of adverse effects (eg, pain or limited activity) |
1 year |
| Recurrent rate |
1 year |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
01/08/2024 |
| 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="1"
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
|
This prospective observational study aims to assess the functional outcomes of patients with Dupuytren’s contracture treated with modified percutaneous needle aponeurotomy technique. Patients were evaluated according to their demographic characteristics, presence of comorbidities, family history, history of drug use. The primary outcome measures will be postoperative Quick-Disability of Arm Shoulder and Hand Questionnaire (Quick-DASH) and URAM scale at 6 months follow up and Secondary outcomes will include a safety assessment, as judged by incidence rate and severity of adverse effects (eg, pain or limited activity) and recurrent rate. . |