Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in SNAC Wrist

Functional Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in Scaphoid Non Union Advanced Collapse (SNAC) Wrist Grade II and III : a Prospective Randomized Controlled Trial

The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique

Study Overview

• Status: Completed
• Conditions: Scaphoid Fracture
• Intervention / Treatment: Procedure: Four corner fusion; Procedure: three corner fusion without triquetrum excision

Detailed Description

There is a controversy regarding the suitable limited wrist arthrodesis technique for SNAC wrist grade II and III . For several decades , scaphoid excision and four corner fusion (between lunate , capitate , hamate and triquetrum) was the gold standard with good functional outcomes . Later on , a more limited fusion technique was described , three corner fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to improve ulnar deviation range . On the other hand , biomechanical studies mentioned that the triquetrum had a certain proprioceptive function that could be affected when it was included in the fusion process .Furthermore , if the triquetrum was excised the radiolunate contact pressure would increase with higher risk of development of arthritis. The aim of the study to compare the conventional four corner fusion with three corner fusion with triquetrum excision

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Al 'Abbāsīyah, Cairo, Egypt, 11655
      • Ain Shams University , Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• SNAC wrist G II , III

Exclusion Criteria:

• cases with radiolunate arthritis
• Scapholunate advanced collapse
• Grade 1 Scaphoid non union advanced collapse
• Kienbock disease
• Skeletally immature patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Four corner fusion; Scaphoid excision and fusion between lunate , capitate , hamate and triquetrum using k.wires	Procedure: Four corner fusion; First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denuded the articulating surfaces between lunate , capitate , hamate and triquetrum . Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones; Other Names: four corner arthrodesis
Experimental: Three corner fusion without triquetrum excision; Scaphoid excision with fusion between lunate , capitate and hamate with preservation of triquetrum	Procedure: three corner fusion without triquetrum excision; First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denude the articulating surfaces between lunate , capitate , hamate and don not include triquetrum. Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	measuring range of motion and sagittal and coronal plane using goniometer	preoperative
Range of motion	measuring range of motion and sagittal and coronal plane using goniometer	one year postoperative
Power grip	Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side	preoperative
Power grip	Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side	one year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	measuring the operative time	Intraoperative
Visual analogue scale	Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain	preoperative
Visual analogue scale	Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain .	one year postoperative
Patient satisfaction	Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities.	preoperative
Patient satisfaction	Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities.	one year postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Mohamed M Elmahy, Professor, Ain Shams University

Publications and helpful links

General Publications

• Bain GI, Sood A, Ashwood N, Turner PC, Fogg QA. Effect of scaphoid and triquetrum excision after limited stabilisation on cadaver wrist movement. J Hand Surg Eur Vol. 2009 Oct;34(5):614-7. doi: 10.1177/1753193408094923. Epub 2009 Jul 10.
• Scobercea RG, Budoff JE, Hipp JA. Biomechanical effect of triquetral and scaphoid excision on simulated midcarpal arthrodesis in cadavers. J Hand Surg Am. 2009 Mar;34(3):381-6. doi: 10.1016/j.jhsa.2008.11.027.
• Delattre O, Goulon G, Vogels J, Wavreille G, Lasnier A. Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. J Hand Surg Am. 2015 Nov;40(11):2176-82. doi: 10.1016/j.jhsa.2015.07.032. Epub 2015 Sep 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: SNAC wrist; Four-corner fusion; Three corner fusion
• Other Study ID Numbers: FMASU M D 296/2019

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