Arthroscopic Scaphoid Grafting Versus Open Grafting in Scaphoid Non Union

NCT ID: NCT07320404

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2023-03-10

Brief Summary

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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

Detailed Description

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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.

Conditions

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Scaphoid Fracture Non Union

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups one with the arthroscopic grafting combined with percutaneous fixation, the second with opend grafting and fixation by K wires.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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arthroscopic A group

arthroscopic bone grafting combined with percutaneous K wires fixation for scaphoid non union patients

Group Type EXPERIMENTAL

Arthroscopic grafting and k wires fixation

Intervention Type PROCEDURE

Arthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation

open O group

open volar or dorsal scaphoid grafting with K wires fixation for scaphoid non union patients

Group Type EXPERIMENTAL

open scaphoid grafting with K wires fixation

Intervention Type PROCEDURE

open surgical volar or dorsal scaphoid non union site debridment and application of iliac bone graft and K wires fixation

Interventions

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Arthroscopic grafting and k wires fixation

Arthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammed El-Mahy, prof.

Role: STUDY_CHAIR

Ain Shams University

Locations

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Faculty of medicine, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Jegal M, Kim JS, Kim JP. Arthroscopic Management of Scaphoid Nonunions. Hand Surg. 2015;20(2):215-21. doi: 10.1142/S0218810415400031.

Reference Type BACKGROUND
PMID: 26051763 (View on PubMed)

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.

Reference Type RESULT
PMID: 15513497 (View on PubMed)

Other Identifiers

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FAMSU MD 288/2019

Identifier Type: -

Identifier Source: org_study_id

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