| CTRI Number |
CTRI/2022/06/043041 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
03/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between Arthroscopic bone grafting to nonvascularized bone grafting for nonunion of the scaphoid fracture |
|
Scientific Title of Study
|
Comparative study between Arthroscopic bone grafting to nonvascularized bone grafting for nonunion of the scaphoid fracture: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed Tahir Ansari |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr. Mohammed Tahir Ansari
Room no 5040,5th floor Department Of Orthopedics
AIIMS, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9868945342 |
| Fax |
|
| Email |
drtahir.ansari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Maldar |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Ward block, AB1 ward
Department Of Orthopedics
AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9481702258 |
| Fax |
|
| Email |
vivekmaldar1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Maldar |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Ward block, AB1 ward,
Department Of Orthopedics,
AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9481702258 |
| Fax |
|
| Email |
vivekmaldar1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Department Of Orthopedics AIIMS New Delhi |
| Address |
All India Institute Of Medical Sciences,
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Vivek Maldar |
Department of Orthopedics, AIIMS New Delhi |
Ward block, first floor,AB1 ward
AIIMS, New Delhi 110029
New Delhi
DELHI |
9481702258
vivekmaldar1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS NEW DELHI |
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 |
ARTHROSCOPIC BONE GRAFTING IN NON UNION FRACTURE OF SCAPHOID |
ARTHROSCOPIC BONE GRAFTING USING DISTAL END RADIUS IN NON UNION OF SCAPHOID FRACTURE CARRIED OUT IN A SINGLE SETTING OF SURGERY AND FOLLOWING UP FOR 6 MONTHS |
| Comparator Agent |
NONVASCULARIZED BONE GRAFTING IN NONUNION OF SCAPHOID FRACTURE |
NONVASCULARIZED BONE GRAFTING USING ILIAC CREST IN NONUNION OF SCAPHOID FRACTURE CARRIED OUT IN A SINGLE SETTING OF SURGERY AND FOLLOWING UP FOR 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic scaphoid nonunion (showing nonunion after > 3 months of trauma irrespective of the treatment received)
2. Failed prior treatment (irrespective of treatment received)
|
|
| ExclusionCriteria |
| Details |
1. Acute fractures.
2. Compound fractures.
3. Avascular proximal fragment.
4. Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for the union of the bone in nonunion scaphoid fracture |
Fracture union will be assessed on the 4th, 8th, 12th week, and on 6th-month in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To find out the incidence of fracture union following arthroscopic bone grafting in nonunion of fracture of the scaphoid
2) To find out the incidence of fracture union following nonvascularized iliac bone grafting in nonunion of fracture of the scaphoid
3) To compare the results in terms of union rate, radiological parameters, clinical parameters, and complications of two modalities of treatment of nonunion of fracture of the scaphoid
|
Fracture union and other parameters will be assessed at 4th,8th, 12th week and 6 months of intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study hypothesis: Arthroscopic bone grafting in non-union of scaphoid fracture will lead to early union compared to nonvascularized iliac bone grafting in non-union of the scaphoid fracture.
The carpal scaphoid is the commonest of carpal bones to be fractured and accounts for more than 60% of all carpal fractures presented. Its small size and orientation make it difficult to image, and hence a fracture may be missed. Wrist osteoarthritis invariably occurs if a scaphoid fracture does not unite. Furthermore, as this fracture mostly occurs in young men, the socioeconomic consequences are considerable.
Thus in scaphoid fractures with nonunion, the timely restoration of scaphoid architecture is most important to prevent the progression of carpal collapse, the occurrence of wrist arthritis, and motion deficits, thus in our study we are going to compare the timeline for union in these two standard procedures i.e arthroscopic bone grafting to nonvascularized iliac bone grafting in nonunion scaphoid fractures, where it is anticipated that arthroscopic bone grafting comes out to be having the earliest time for union |