| CTRI Number |
CTRI/2026/01/100151 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find any predisposing factors affecting the outcome in patients who underwent surgery for non-uniting scaphoid bone fracture in wrist complicated by decreased vascularity |
|
Scientific Title of Study
|
To evaluate the prognostic factors affecting the functional outcome of patients with scaphoid nonunion with proximal pole avascular necrosis treated with vascularized bone graft |
| 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 Deepak Kumar |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
15, Office of Department of orthopedics, Ground floor, Nehru Hospital, PGIMER 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8307259358 |
| Fax |
|
| Email |
drdeepaknegimt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
15, Office of Department of orthopedics, Ground floor, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8307259358 |
| Fax |
NA |
| Email |
10.250.yogeshkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
15, Office of Department of orthopedics, Ground floor, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8307259358 |
| Fax |
|
| Email |
10.250.yogeshkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER THESIS GRANT |
| Address |
PGIMER, Chandigarh 160012 |
| 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 |
| Dr Yogesh Kumar |
PGIMER, Chandigarh |
15, Office of Department of orthopedics, Ground floor, Nehru Hospital, PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH |
8307259358
10.250.yogeshkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S620||Fracture of navicular [scaphoid] bone of wrist, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients with scaphoid fracture nonunion with avascular necrosis undergoing open reduction and internal fixation along with vascularised bone graft |
|
| ExclusionCriteria |
| Details |
1)Previous scaphoid surgery
2)Active infection or arthritis in wrist
3)Inadequate clinical and radiological details for retrospective cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the prognostic factors affecting functional outcomes of patients with scaphoid nonunion with proximal pole avascular necrosis treated with vascularized bone graft using clinical scores and radiological studies |
at baseline, 2 weeks, 6 weeks, 12 weeks and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess functional outcome with help of Modified mahyo wrist score, Patient rated wrist evaluation, Quick Disabilities of Arm Shoulder & hand score, 12 item short form health survey questonnaire |
at baseline, 12 weeks, 6 months |
| To assess radiographical parameters of fracture union, vascularity of proximal pole and carpal alignment |
|
| To find correlation between vascularity of proximal pole and functional outcomes using contrast enhanced studies |
|
| To determine union rates, time to union and incidence of any complications |
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/01/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - orthopedics trauma journals and PGIMER library
- For how long will this data be available start date provided 15-12-2026 and end date provided 15-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An ambispective observational study to evaluate prognostic factors affecting functional outcomes in patients with scaphoid nonunion with avascular necrosis after open reduction and internal fixation, and vascularized bone graft and the clinical and radiological outcomes, such as functional outcomes using multiple scores( Modified Mayo wrist score, Patient-rated wrist evaluation, QuickDASH score, 12 item short form health survey) and the vascularity status of proximal pole atleast 6 months after mentioned surgery.
The scaphoid is the most common carpal bone to fracture in the wrist, mostly seen in young males after a fall on an outstretched hand which has high tendency to go into non-union and is associated with avascular necrosis of the proximal fragment, affecting wrist functions in young individuals, causing loss of occupation in some cases This project aims to collect more data on scaphoid nonunion with associated avascular necrosis after fixation and vascularised bone grafting, rather than the earlier practice of non-vascularised bone grafting. |