| CTRI Number |
CTRI/2024/07/069954 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of Surgical Management of Intra-articular Fractures of Distal Humerus in Adults
|
|
Scientific Title of Study
|
Functional Outcome of Surgical Management of Intra-articular Fractures of Distal Humerus in Adults
|
| 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 Gurpreet Singh Saluja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinobha Bhave rural hospital sawangi meghe, district Wardha, Department of orthopedic room number 1
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169536875 |
| Fax |
|
| Email |
lifeofgss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar Dhaniwala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinobha Bhave rural hospital sawangi meghe, district Wardha, Department of orthopedic room number 1
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422188450 |
| Fax |
|
| Email |
nsdhaniwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Kumar Dhaniwala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinobha Bhave rural hospital sawangi meghe, district Wardha, Department of orthopedic room number 1
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422188450 |
| Fax |
|
| Email |
nsdhaniwala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinobha Bhave Rural Hospital Sawangi Meghe, District Wardha, Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Acharya Vinobha Bhave Rural Hospital Sawangi Meghe |
| Address |
Acharya Vinobha Bhave Rural Hospital Sawangi Meghe, District Wardha, Maharashtra India 442001 |
| 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 |
| Dr Naresh Kumar Dhaniwala |
Acharya Vinobha Bhave Rural Hospital Sawangi Meghe, District Wardha |
Department of Orthopedic Acharya Vinobha Bhave Rural Hospital Sawangi Meghe, District Wardha
Wardha
MAHARASHTRA |
8169536875
nsdhaniwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Open Reduction Internal Fixation (ORIF) |
The intervention involves surgical management of intra-articular distal humerus fractures using open reduction internal fixation (ORIF) with pre-operative evaluation, trans-olecranon approach, post-operative early mobilization, and periodic follow-ups
FOLLOW UP WILL BE IN 6 WEEKS, 3 MONTHS AND 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The study includes patients who meet specific criteria to ensure the relevance and effectiveness of the intervention. Firstly, all patients with intra-articular fractures of the distal humerus are considered eligible for the study. This inclusion is crucial as it focuses on a particular type of fracture that the intervention aims to treat. Secondly, the study targets adults, specifically those aged more than 18 years, to ensure that the results are applicable to the adult population who typically undergo this type of surgery. Lastly, only those patients who provide informed consent for the surgical procedure are included, ensuring that participants are willing and informed about the surgical intervention and its implications. |
|
| ExclusionCriteria |
| Details |
To ensure safety and validity, patients unfit for surgery, with extreme osteoporosis, open fractures, or pathological fractures are excluded to avoid complications, negative impacts on outcomes, and confounding results. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the functional assessment of the distal humerus following surgical management. |
6 WEEKS , 3 MONTHS AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain levels, complications, and overall patient satisfaction post-surgery. |
6 weeks: Evaluate pain levels and early complications.
3 months: Monitor ongoing recovery, pain levels, and any intermediate complications.
6 months: Assess long-term pain management, complications, and patient satisfaction with the surgical outcome. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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 Yet Recruiting |
| 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 case series study aims to assess the functional outcomes of surgical management for intra-articular fractures of the distal humerus in adults. Conducted at Acharya Vinobha Bhave Rural Hospital Sawangi (Meghe) Wardha, the study will include 30 patients aged over 18 years who have sustained these fractures and consented to surgery. Exclusion criteria ensure patient safety by omitting individuals unfit for surgery, those with extreme osteoporosis, open fractures, or pathological fractures. The intervention involves open reduction internal fixation (ORIF), with pre-operative evaluation, trans-olecranon approach during surgery, and post-operative early mobilization. The primary outcomes will be measured using MAYO and DASH scoring at 6 weeks, 3 months, and 6 months to evaluate pain, fracture union, and functional outcomes. Secondary outcomes include assessing pain levels, complications, and overall patient satisfaction at these time points. The study will utilize statistical methods to confirm the significance of the results, contributing valuable insights into the efficacy of ORIF for distal humerus fractures. |