Scaphoid Fracture Clinical Trial
Official title:
Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics
NCT number | NCT04892862 |
Other study ID # | 2020/779 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | July 1, 2022 |
Verified date | August 2022 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
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 |
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