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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05362240
Collaborator
(none)
34
1
2
38.4
0.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Four corner fusion
  • Procedure: three corner fusion without triquetrum excision
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excisionTwo groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excision
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Dec 2, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Range of motion [preoperative]

      measuring range of motion and sagittal and coronal plane using goniometer

    2. Range of motion [one year postoperative]

      measuring range of motion and sagittal and coronal plane using goniometer

    3. Power grip [preoperative]

      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

    4. Power grip [one year postoperative]

      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

    Secondary Outcome Measures

    1. operative time [Intraoperative]

      measuring the operative time

    2. Visual analogue scale [preoperative]

      Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain

    3. Visual analogue scale [one year postoperative]

      Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain .

    4. Patient satisfaction [preoperative]

      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.

    5. Patient satisfaction [one year postoperative]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University , Faculty of medicine Al 'Abbāsīyah Cairo Egypt 11655

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05362240
    Other Study ID Numbers:
    • FMASU M D 296/2019
    First Posted:
    May 5, 2022
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ain Shams University

    Study Results

    No Results Posted as of May 5, 2022