NCT05362240

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

May 2, 2022

Last Update Submit

May 4, 2022

Conditions

Keywords

SNAC wristFour-corner fusionThree corner fusion

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • operative time

    Intraoperative

  • Visual analogue scale

    preoperative

  • Visual analogue scale

    one year postoperative

  • Patient satisfaction

    preoperative

  • Patient satisfaction

    one year postoperative

Study Arms (2)

Four corner fusion

EXPERIMENTAL

Scaphoid excision and fusion between lunate , capitate , hamate and triquetrum using k.wires

Procedure: Four corner fusion

Three corner fusion without triquetrum excision

EXPERIMENTAL

Scaphoid excision with fusion between lunate , capitate and hamate with preservation of triquetrum

Procedure: three corner fusion without triquetrum excision

Interventions

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

Also known as: four corner arthrodesis
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 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.

Three corner fusion without triquetrum excision

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • SNAC wrist G II , III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University , Faculty of medicine

Al ‘Abbāsīyah, Cairo Governorate, 11655, Egypt

Location

Related 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.

    PMID: 19592604BACKGROUND
  • 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.

    PMID: 19258133BACKGROUND
  • 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.

    PMID: 26409577BACKGROUND

Study Officials

  • Mohamed M Elmahy, Professor

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excision
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

September 20, 2018

Primary Completion

October 30, 2021

Study Completion

December 2, 2021

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations