Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Scaphoid Fracture
• Intervention / Treatment: Procedure: vascularized bone graft for scaphois 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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ismail, master; Phone Number: 00201025445484; Email: drortho87@yahoo.com
• Study Contact Backup: Name: Tareq elgammal, M.D; Phone Number: 01005229293; Email: tarek.elgammal@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: scaphoid nonunion; pedicled and free ABG for treatment of scaphoid nonunion	Procedure: vascularized bone graft for scaphois nonunion; vascularized bone graft for scaphois nonunion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29	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 .	2 years
Mayo wrist score of 60 - 100 will be satisfactory	The final end results will be assessed according to modified Mayo wrist score of 60 - 100 will be satisfactory . Secondary (subsidiary):	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carpal Alignment Before and After VBG	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	2 years
Scaphoid Height-to-length ratio	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).	2 years
Scapholunate angle	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	2 years
Radio-lunate angle	Radiolunate angle is the angle between the longitudinal axes of radius and lunate in lateral view	2 years
Lateral interscaphoid angle	Normal lateral intrascaphoid angle averages 30 degrees	2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Kotb, M.D, Assiut University

Publications and helpful links

General Publications

• Dias JJ, Brenkel IJ, Finlay DB. Patterns of union in fractures of the waist of the scaphoid. J Bone Joint Surg Br. 1989 Mar;71(2):307-10. doi: 10.1302/0301-620X.71B2.2925752.
• Szabo RM, Manske D. Displaced fractures of the scaphoid. Clin Orthop Relat Res. 1988 May;(230):30-8.
• El-Karef EA. Corrective osteotomy for symptomatic scaphoid malunion. Injury. 2005 Dec;36(12):1440-8. doi: 10.1016/j.injury.2005.09.003. Epub 2005 Oct 27.
• Lynch NM, Linscheid RL. Corrective osteotomy for scaphoid malunion: technique and long-term follow-up evaluation. J Hand Surg Am. 1997 Jan;22(1):35-43. doi: 10.1016/S0363-5023(05)80177-7.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): May 15, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VBGs for scaphoid nonunion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No