Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2024-09-01

Brief Summary

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To assess the effect of vascularized bone grafting on the functional, clinical and radiological outcomes of the scaphoid nonunion

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Detailed Description

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The scaphoid is the most commonly fractured carpal bone accounting for 60% of fractures. A number of case series have identified a 10%-15% nonunion rate. Scaphoid nonunion refers to a spectrum of failed healing, each of which requires a tailored approach.

Subsequent to non-union, degenerative changes with the formation of cysts, bony resorption with loss of bone stock and the development of apex dorsal angulation or the humpback deformity may occur leading to scaphoid non-union advanced collapse (SNAC) of the wrist and the formation of a proximal pole which extends with the lunate.

This has serious functional implications for the patient in terms of wrist range of movement, grip strength and general activities of daily living . The management of nonunion has remained controversial since the last century.

Bone grafting has been performed since the late 1920s with positive results. The importance of vascularity was enforced by finding that in the presence of avascular necrosis ( AVN ), conventional non vascularized bone grafts ( NVBGs) could only achieve a 47% union rate . However, in the absence of AVN, these NVBGs could achieve union rates of 94% .

There was growing consensus that new techniques were required to address the shortfall, and accordingly, vascularized bone grafting (VBG) techniques stemmed from this. It was widely believed that providing adequate blood flow would help treat cases of non-union . Several studies demonstrate that VBGs accelerated bone healing by preserving osteocytes and preventing the slower creeping substitution and were able to increase blood flow and superior mechanical properties in VBGs as opposed to NVBGs . VBGs could be further classified into pedicled or free VBGs. Pedicled VBGs involve isolating a segment of bone local to the defect and maintaining the blood supply to this segment of donor bone which is then fixed into the recipient site. This requires a good stock of donor bone in close proximity to the defect. Free VBGs involve detaching a segment of bone with its vascular bundle from a donor site and anastomosing this to recipient vessels with the fixation of the donor bone to recipient bone.This study hypothesis that VBGs should be used in all cases of humpback deformity , proximal pole fracture , AVN and cystic degeneration from the start.

Conditions

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Scaphoid Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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scaphoid nonunion

pedicled and free ABG for treatment of scaphoid nonunion

Group Type EXPERIMENTAL

vascularized bone graft for scaphois nonunion

Intervention Type PROCEDURE

vascularized bone graft for scaphois nonunion

Interventions

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vascularized bone graft for scaphois nonunion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All Patients will be included if they met the following criteria:

* Age: all patient more than 18 years up to 55 years
* Fracture: nonunion and a vascular necrosis proved by MRI (Herbert stage I or II) , humpback deformity, Proximal pole fracture, cystic degeneration, failed previous surgery (K wire, Herbert, plate distal radius)
* Pain: persistent disabling pain and tenderness at wrist joint due to scaphoid nonunion.

patient: both sex will included, both handiness, good bone quality.