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

Scaphoid Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362240
• Other study ID #: FMASU M D 296/2019
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: December 2, 2021

Study information

• Verified date: May 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Scaphoid Fracture

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University , Faculty of medicine	Al 'Abbasiyah	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion	measuring range of motion and sagittal and coronal plane using goniometer	preoperative
Primary	Range of motion	measuring range of motion and sagittal and coronal plane using goniometer	one year postoperative
Primary	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
Primary	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	operative time	measuring the operative time	Intraoperative
Secondary	Visual analogue scale	Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain	preoperative
Secondary	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
Secondary	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
Secondary	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