Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

Not Applicable

Not yet recruiting

• Conditions: Scaphoid Fracture
• Interventions: Procedure: vascularized bone graft for scaphois nonunion

• Registration Number: NCT05358015
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-05-03
• Last Update Posted: 2022-05-03
• Study Start: 2022-05-15
• Primary Completion: 2024-05-15
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Exclusion Criteria

• Commuted Other carpus fractures
• Nonunion less than 3 months
• Radio-carpal Arthritis or instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
scaphoid nonunion	vascularized bone graft for scaphois nonunion	pedicled and free ABG for treatment of scaphoid nonunion

Primary Outcome Measures

Name	Time	Method
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29	2 years	The final end results will be assessed according to DASH score , a DASH score ranging from 0 to 29 was thought by most respondents to be the point where patients/clients were 'no longer considering their upper-limb disorder a problem .
Mayo wrist score of 60 - 100 will be satisfactory	2 years	The final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory .; Secondary (subsidiary):

Secondary Outcome Measures

Name	Time	Method
Carpal Alignment Before and After VBG	2 years	the articular surfaces of the proximal and distal carpal rows should form three smooth arcs , the spacing between all carpal bones should be 1-2 mm in antroposterior view and the distal radius, lunate and capitate should be in a straight line in lateral view
Scapholunate angle	2 years	Scapholunate angle is the angle between longitudinal axes of lunate and scaphoid (tangential line from the dorsum of scaphoid) in the lateral radiograph the scapholunate angle should be between 30o and 60o in the neutral position
Scaphoid Height-to-length ratio	2 years	The mean normal H/L ratio in the sagittal plane was 0.61 (range, 0.54-0.69) and in the coronal plane 0.42 (range, 0.36-0.48).
Lateral interscaphoid angle	2 years	Normal lateral intrascaphoid angle averages 30 degrees
Radio-lunate angle	2 years	Radiolunate angle is the angle between the longitudinal axes of radius and lunate in lateral view