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Clinical Trials/CTRI/2022/06/043041
CTRI/2022/06/043041Not yet recruitingNot Applicable

Comparative study between Arthroscopic bone grafting to nonvascularized bone grafting for nonunion of the scaphoid fracture: A Randomized Control Trial

Department Of Orthopedics AIIMS New Delhi1 site in 1 country30 target enrollmentStarted: October 6, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Time taken for the union of the bone in nonunion scaphoid fracture

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Chronic scaphoid nonunion (showing nonunion after > 3 months of trauma irrespective of the treatment received) 2.Failed prior treatment (irrespective of treatment received).

Exclusion Criteria

  • 1.Acute fractures.
  • 2.Compound fractures.
  • 3.Avascular proximal fragment.
  • 4.Patients not willing to participate in the study.

Outcomes

Primary Outcomes

Time taken for the union of the bone in nonunion scaphoid fracture

Time Frame: Fracture union will be assessed on the 4th, 8th, 12th week, and on 6th-month in the postoperative period

Secondary Outcomes

  • 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)

Investigators

Sponsor
Department Of Orthopedics AIIMS New Delhi
Sponsor Class
Research institution and hospital

Study Sites (1)

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