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Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05358015
Enrollment
25
Registered
2022-05-03
Start date
2022-05-15
Completion date
2024-09-01
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scaphoid Fracture

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.

Interventions

PROCEDUREvascularized bone graft for scaphois nonunion

vascularized bone graft for scaphois nonunion

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 292 yearsThe 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 satisfactory2 yearsThe final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory . Secondary (subsidiary):

Secondary

MeasureTime frameDescription
Scapholunate angle2 yearsScapholunate 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
Carpal Alignment Before and After VBG2 yearsthe 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
Lateral interscaphoid angle2 yearsNormal lateral intrascaphoid angle averages 30 degrees
Radio-lunate angle2 yearsRadiolunate angle is the angle between the longitudinal axes of radius and lunate in lateral view
Scaphoid Height-to-length ratio2 yearsThe 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).

Contacts

Primary ContactMohamed Ismail, master
drortho87@yahoo.com00201025445484
Backup ContactTareq elgammal, M.D
tarek.elgammal@aun.edu.eg01005229293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026