Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics

Scaphoid Fracture Clinical Trial

Official title:

Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892862
• Other study ID #: 2020/779
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At least 23 working male patients between the ages of 20-50 who do not have active additional diseases will be included in the study, and those who have not previously had trauma or surgical intervention on the same extremity, and who do not have vascular and neurological fields, These patients will be followed-up at the itf orthopedic clinic and the medical faculty orthopedics clinic. their patients will be After the preop and postop union is provided to the patients who will be divided into 2 groups of at least 10 people (in the 12th month postop), the wrist motion analysis will be performed with the XSENS MTw Awinda 17 sensor full body motion capture system in the Bahçeşehir University biomechanics laboratory (separate on the healthy side). In addition to the rum, 5 movements such as personal wc cleaning, drinking coffee from the cup will be stimulated by looking at the healthy side.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion

• 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 DEFOMITY and radiocarpal arthrosis on affected wrist

• there must be minimum 1 year maximum 10 year between trauma and surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Scaphoid Fracture

Intervention

Procedure:
• SCAHOID GRAPHONAGE WITH AUTOGRAPH FROM DISTAL RADIUS BY DORSAL APPROACH
ON GENERAL OR LOCAL ANESTESIA PATIENT N SUPINE POSTION EFFECTED WRIST 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.
• SCAHOID GRAPHONAGE WITH AUTOGRAPH FROM DISTAL RADIUS BY VOLAR APPROACH
ON GENERAL OR LOCAL ANESTESIA PATIENT N SUPINE POSTION EFFECTED WRIST ON ARM TABLE . INCISION STARTS 2 CM RADIAL TO SCAPHOID TUBERCULE EXTENTS ITS 3 CM PROXIMAL . AFTER PASING SUBCUTANEOUS TISSUE , FCR AND RADIAL ARTERY ARE IDENTIFIED AND DIVIDED 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 WITH PASSING PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTIMETER 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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	key pinch ,	each patient will do Lateral pinch (key pinch): Place the pinchmeter between the radial side of index finger and thumb, and instruct the client to pinch as hard as possible) , pinchmeter measures in pound( 1 lb=0.45kg)	preoperation , avarage of first year after operation
Other	measurement of range of motions in tasks with xsens motion capture system	we have determined four tasks (drinking coffe,reaching tail bone from front,using phone,reaching backpack from back ) we repeated task 3 times measured wrist range of motions during tasks ,	preoperation , avarage of first year after operation
Other	jamar hand dynomometer	prosedure with both hands which describe in ''Optimal Jamar Dynamometer Handle Position to Assess Maximal Isometric Hand Grip Strength in Epidemiological Studies'' Ulrike Sonja Trampisch, PhD, Julia Franke, PhD, Nina Jedamzik, MSc, Timo Hinrichs, MD, Petra Platen, MD, three times most high value will accept (jamar dynomometer measures in kilogram unit ,	preoperation , avarage of first year after operation
Primary	CHANGES IN WRIST RANGE OF MOTION	measure wrist range of motion with goniometer	preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year
Primary	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	DASH score	Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. The DASH questionnaire is used as an indicator of the impact of an impairment on the level and type of disability we expect decrease after operation	preoperation , avarage of first year after operation
Secondary	HAND MAYO SCORE	Mayo Wrist Score -- OrthoToolKit Scores range from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition. Original Literature: Cooney, W. P., et al. "Difficult wrist fractures.	preoperation , avarage of first year after operation
Secondary	VAS SCORES	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	preoperation , avarage of first year after operation