NCT04892862

Brief Summary

Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

March 23, 2021

Last Update Submit

August 23, 2022

Conditions

Scaphoid Fracture

Outcome Measures

Primary Outcomes (2)

  • CHANGES İN WRİST RANGE OF MOTİON

    measure wrist range of motion with goniometer

    preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year

  • assess bone union

    assesing union on wrist antero-posterior/ lateral x-rays, by identification of trabeculae crossing the fracture line or sclerosis at the fracture line

    3 weeks to 3 months post-op

Secondary Outcomes (3)

  • DASH score

    preoperation , avarage of first year after operation

  • HAND MAYO SCORE

    preoperation , avarage of first year after operation

  • VAS SCORES

    preoperation , avarage of first year after operation

Other Outcomes (3)

  • key pinch ,

    preoperation , avarage of first year after operation

  • measurement of range of motions in tasks with xsens motion capture system

    preoperation , avarage of first year after operation

  • jamar hand dynomometer

    preoperation , avarage of first year after operation

Study Arms (2)

dorsal surgical approach

ACTIVE COMPARATOR

dorsal surgical approach

Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH

volar surgical approach

ACTIVE COMPARATOR

volar surgical approach

Procedure: SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH

Interventions

SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACHPROCEDURE

ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . LISTER TUBERCULA WITH 3 CM PROXIMAL AND 3 CM DISTAL IN INCISION MADE UNDER THE SKIN. 2,3 EXTENSOR COMPARTMENTS RADIAL 4. THE EXTENSON COMPARTMENT IS EARTHED TO ULNAR A AND THE WRIST JOINT CAPSULE IS REACHED. THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision ON DISTAL UNDER RADIUS metaphyseal area of 2CM. 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.

dorsal surgical approach
SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACHPROCEDURE

ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . İNCİSİON STARTS 2 CM RADİAL TO SCAPHOİD TUBERCULE EXTENTS ITS 3 CM PROXİMAL . AFTER PASİNG SUBCUTANEOUS TİSSUE , FCR AND RADİAL ARTERY ARE İDENTİFİED AND DİVİDED SEPERATLY THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision WİTH PASSİNG PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTİMETER OF RADIUS metaphyseal area . 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.

volar surgical approach

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healty male
  • without any chronic systemic dissease
  • must not have drug addiction
  • must not have surgical prosedure on affected upper extremity before
  • patient shouldnt have VISI DISI DEFOMİTY and radiocarpal arthrosis on affected wrist
  • there must be minimum 1 year maximum 10 year between trauma and surgery

You may not qualify if:

  • Criteria:having vascular and neurological spaces in the same extremity without previous trauma or surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: PROSPECTIVE CLİNİCAL TRİAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

May 19, 2021

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)