Arthroscopic Scaphoid Grafting Versus Open Grafting in Scaphoid Non Union

Arthroscopic Scaphoid Bone Graft Combined With Percutaneous Fixation Versus Open Scaphoid Fixation With Non Vascularized Graft in Scaphoid Non-union

the investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient

Study Overview

• Status: Completed
• Conditions: Scaphoid Fracture Non Union
• Intervention / Treatment: Procedure: Arthroscopic grafting and k wires fixation; Procedure: open scaphoid grafting with K wires fixation

Detailed Description

The treatment of scaphoid non union has no gold standard technique so in this study the investigators try to compare the arthroscopic and the open grafting techniques to determine the better technique to achieve union, time to union and the better functional outcomes including wrist range of motion and grip strength as a primary outcome and the secondary outcomes are the operative time, the complications and radiological correction of the hum-back deformity if present.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• scaphoid non-union cases
• 16 years or older
• males or females
• independent from chronicity or non-union location and the investigators defined the non union as failure to reach scaphoid union up to 6 months

Exclusion Criteria:

.Revision scaphoid non-union cases.

• Previously operated wrist for any other pathology
• Avascular necrosis (AVN) confirmed by intraoperative inspection.
• Scaphoid non-union advanced collapse (SNAC) stage 2 and higher.
• Any associated wrist pathology that required separate treatment surgical approach.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arthroscopic A group; arthroscopic bone grafting combined with percutaneous K wires fixation for scaphoid non union patients	Procedure: Arthroscopic grafting and k wires fixation; Arthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation
Experimental: open O group; open volar or dorsal scaphoid grafting with K wires fixation for scaphoid non union patients	Procedure: open scaphoid grafting with K wires fixation; open surgical volar or dorsal scaphoid non union site debridment and application of iliac bone graft and K wires fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
union rate	percentage of patients in each arm that achieve bony union	6 months
time to union	the time that patient take to achieve bony union	6 to 24 weeks
wrist flexion and extension	flexion and extension range of motion	preoperative, at 6 months and at 24 months
wrist radial and ulnar deviation	radial and ulnar deviation range of motion	preoperative, at 6 months and at 24 months
grip strength	the power of hand grip measured by dynamometer	preoperative , at 6 months and at 24 months
The disability of arm, shoulder and hand score (DASH score)	a questionnaire to assess upper limb function from 0 to 100 where the lower the score means better outcome	preoperative , at 6 months and at 24 months
The Mayo modified wrist score	A functional score that depends on the patients function and examination from 0 to 100 and the higher the score the higher the outcome	preoperative, at 6 months and at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications		2 years post operative
Degree of scaphoid hump back deformity correction	Radiological parameter thorough scapholunate angle	post operative after bony union up to 1 year
Operative time	the duration of each operation	intraoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Mohammed El-Mahy, prof., Ain Shams University

Publications and helpful links

General Publications

• Jegal M, Kim JS, Kim JP. Arthroscopic Management of Scaphoid Nonunions. Hand Surg. 2015;20(2):215-21. doi: 10.1142/S0218810415400031.
• Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004 Oct;75(5):618-29. doi: 10.1080/00016470410001529.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FAMSU MD 288/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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