Vascularized Bone Grafts for Treatment of Scaphoid Nonunion

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05358015
Collaborator
(none)
25
1
27.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: vascularized bone graft for scaphois nonunion
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study
Anticipated Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
May 15, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 .

  2. 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

  1. 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

  2. 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).

  3. 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

  4. Radio-lunate angle [2 years]

    Radiolunate angle is the angle between the longitudinal axes of radius and lunate in lateral view

  5. Lateral interscaphoid angle [2 years]

    Normal lateral intrascaphoid angle averages 30 degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Mostafa abdelhady Ismail, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05358015
Other Study ID Numbers:
  • VBGs for scaphoid nonunion
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 3, 2022