Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

NCT05358015 | Unknown DMC

• 1 other identifier: VBGs for scaphoid nonunion
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Scaphoid Fracture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Carpal Alignment Before and After VBG

  2 years

• Scaphoid Height-to-length ratio

  2 years

• Scapholunate angle

  2 years

• Radio-lunate angle

  2 years

• Lateral interscaphoid angle

  2 years

Study Arms (1)

scaphoid nonunion

EXPERIMENTAL

pedicled and free ABG for treatment of scaphoid nonunion

Procedure: vascularized bone graft for scaphois nonunion

Interventions

vascularized bone graft for scaphois nonunion PROCEDURE

vascularized bone graft for scaphois nonunion

scaphoid nonunion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 2925752 BACKGROUND

• Szabo RM, Manske D. Displaced fractures of the scaphoid. Clin Orthop Relat Res. 1988 May;(230):30-8.

  PMID: 3284681 BACKGROUND

• 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.

  PMID: 16256995 BACKGROUND

• 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.

  PMID: 9018610 BACKGROUND

Study Officials

• Mohamed Kotb, M.D

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Ismail, master

CONTACT

00201025445484; drortho87@yahoo.com

Tareq elgammal, M.D

CONTACT

01005229293; tarek.elgammal@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: May 15, 2022
• Primary Completion: May 15, 2024
• Study Completion: September 1, 2024
• Last Updated: May 3, 2022

Record last verified: 2022-04