Clinical trial NCT05358015: Vascularized Bone Grafts for Treatment of Scaphoid Nonunion
Official title: Vascularised Bone Grafts for Treatment of Scaphoid Nonunion: a Case Series Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scaphoid Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability of the arm,shoulder and hand ( DASH) score ranging from 0 to 29
timeFrame: 2 years
measure: Mayo wrist score of 60 - 100 will be satisfactory
timeFrame: 2 years
Secondary outcomes:
measure: Carpal Alignment Before and After VBG
timeFrame: 2 years
measure: Scaphoid Height-to-length ratio
timeFrame: 2 years
measure: Scapholunate angle
timeFrame: 2 years
measure: Radio-lunate angle
timeFrame: 2 years
measure: Lateral interscaphoid angle
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Kotb, M.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Szabo RM, Manske D. Displaced fractures of the scaphoid. Clin Orthop Relat Res. 1988 May;(230):30-8.
citation: 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.
citation: 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.