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Manual Dexterity in Ulnar Styloid Fracture Patients

Primary Purpose

Ulnar Styloid Fracture, Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hand Therapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Styloid Fracture focused on measuring DISTAL RADIUS FRACTURE, ULNAR STYLOID FRACTURE, MANUAL DEXTERITY

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The criteria for inclusion in this prospective cohort study were; 1) Aged between 18 and 60 years, 2) Diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture, 3) Primarily fixation after injury

Exclusion Criteria:

  • Exclusion criteria were; 1)Radius shaft, ulnar head or ulnar shaft fractures, 2) Pre-existing rheumatological diseases associated with ipsilateral extremity, 3) Comorbid injuries such as tendon or nerve injuries, 4) Coexisting distal radioulnar, radiocarpal or ulnocarpal joint instability problems, 5) Secondarily repair.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    USF Group

    NON-USF Group

    Arm Description

    DRF with ulnar styloid fracture

    DRF without ulnar styloid fracture

    Outcomes

    Primary Outcome Measures

    Pain
    The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity
    Range of motion
    Patients' forearm and wrist joints ROM (pronation, supination, flexion, extension, radial and ulnar deviation) were measured with an universal goniometer
    Grip and Pinch Strength
    The handgrip and pinch strengths were measured according to standard strength measurement method suggested by American Society of Hand Therapists respectively using a hand dynamometer and a pinch meter
    Quick-The Disabilities of the Arm, Shoulder and Hand (Q-DASH)
    It was used to a shortened version of the DASH Outcome Measure. Instead of 30 items, the Quick-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb
    Purdue Pegboard Test
    Four subtests of the Purdue Pegboard Test (1-800-428-7545, Model 32020, Lafayette Instrument Co., IL, USA) (right hand, left hand, both hands and assembly) were performed to measure fine manual dexterity of the hands after DRF
    Jebsen Taylor Hand Function Test
    The seven individual subtests of JTHFT (Sammons Preston Ability One, #8063) including writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects were performed in a standardized procedure

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2020
    Last Updated
    April 20, 2020
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04357470
    Brief Title
    Manual Dexterity in Ulnar Styloid Fracture Patients
    Official Title
    Ulnar Styloid Fracture Accompanying Distal Radius Fracture Does Not Affect Functional Results, But What About Manual Dexterity?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 12, 2016 (Actual)
    Primary Completion Date
    September 14, 2019 (Actual)
    Study Completion Date
    March 20, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Fracture of the distal radius (DRF) is a common musculoskeletal system injury. Fracture of the ulnar styloid frequently accompanies fractures of the distal radius and is seen in 50-65% of these cases. The loss of dexterity is common in many musculoskeletal conditions. The aim of this study was to investigate whether an associated ulnar styloid fracture following a distal radius fracture has any effect on manual dexterity. Patients who diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture and applied to hand rehabilitation unit were included in the study. The patients were divided into two groups according to the ulnar styloid fracture presence. USF Group was DRF with ulnar styloid fracture; NON-USF Group was DRF without ulnar styloid fracture. Pain, range of motion, Quick-DASH, hand grip and pinch strength, Purdue Pegboard Test, Jebsen Taylor Hand Function Test was measured at six month. A total of 125 patients, 68 female (54,4%) and 57 male (45,6%) were included in the study. The mean age of the patients was 47,15±13,41 (18-65) years. 65 of the patients (52%) had isolated fracture of the distal radius fracture (NON-USF group) and 60 patients (48%) had a concurrent ulnar styloid fracture (USF group). There was no significant difference in pain between the groups (p>0,05). Joints range of motion were higher in the NON-USF group than in the USF group. This difference was statistically significant only for flexion and extension (p<0,05). There was no statistically significant difference in Quick-DASH score between groups (p>0,05). The injured hand grip and pinch strength values in NON-USF group were greater than the USF group but the difference was not statistically significant (p>0,05). The manual dexterity and hand function tests showed that there was no statistically significant difference between the groups at six months (p>0,05). There is a consensus that ulnar styloid fracture has no effect on overall hand function. But, there is no study dwelled on the manual dexterity. In this study, the effect of ulnar styloid fracture on hand function is more clearly emphasized. In conclusion, concomitant USF does not lead poorer manual dexterity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulnar Styloid Fracture, Distal Radius Fracture
    Keywords
    DISTAL RADIUS FRACTURE, ULNAR STYLOID FRACTURE, MANUAL DEXTERITY

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who diagnosed diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture and applied to hand rehabilitation unit were included in the study. The patients were divided into two groups according to the ulnar styloid fracture presence. USF Group was DRF with ulnar styloid fracture; NON-USF Group was DRF without ulnar styloid fracture.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    USF Group
    Arm Type
    Active Comparator
    Arm Description
    DRF with ulnar styloid fracture
    Arm Title
    NON-USF Group
    Arm Type
    Active Comparator
    Arm Description
    DRF without ulnar styloid fracture
    Intervention Type
    Other
    Intervention Name(s)
    Hand Therapy
    Other Intervention Name(s)
    Rehabilitation
    Intervention Description
    The patients were admitted to 12-weeks rehabilitation program and were called up once a week for follow-up appointments. Hand therapy continued as home program between 12th week and 6th month.
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity
    Time Frame
    six month
    Title
    Range of motion
    Description
    Patients' forearm and wrist joints ROM (pronation, supination, flexion, extension, radial and ulnar deviation) were measured with an universal goniometer
    Time Frame
    six month
    Title
    Grip and Pinch Strength
    Description
    The handgrip and pinch strengths were measured according to standard strength measurement method suggested by American Society of Hand Therapists respectively using a hand dynamometer and a pinch meter
    Time Frame
    six month
    Title
    Quick-The Disabilities of the Arm, Shoulder and Hand (Q-DASH)
    Description
    It was used to a shortened version of the DASH Outcome Measure. Instead of 30 items, the Quick-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb
    Time Frame
    six month
    Title
    Purdue Pegboard Test
    Description
    Four subtests of the Purdue Pegboard Test (1-800-428-7545, Model 32020, Lafayette Instrument Co., IL, USA) (right hand, left hand, both hands and assembly) were performed to measure fine manual dexterity of the hands after DRF
    Time Frame
    six month
    Title
    Jebsen Taylor Hand Function Test
    Description
    The seven individual subtests of JTHFT (Sammons Preston Ability One, #8063) including writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects were performed in a standardized procedure
    Time Frame
    six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The criteria for inclusion in this prospective cohort study were; 1) Aged between 18 and 60 years, 2) Diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture, 3) Primarily fixation after injury Exclusion Criteria: Exclusion criteria were; 1)Radius shaft, ulnar head or ulnar shaft fractures, 2) Pre-existing rheumatological diseases associated with ipsilateral extremity, 3) Comorbid injuries such as tendon or nerve injuries, 4) Coexisting distal radioulnar, radiocarpal or ulnocarpal joint instability problems, 5) Secondarily repair.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HANDE USTA, MSC
    Organizational Affiliation
    Research Assistant
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29576925
    Citation
    Almedghio S, Arshad MS, Almari F, Chakrabarti I. Effects of Ulnar Styloid Fractures on Unstable Distal Radius Fracture Outcomes: A Systematic Review of Comparative Studies. J Wrist Surg. 2018 Apr;7(2):172-181. doi: 10.1055/s-0037-1607214. Epub 2017 Oct 11.
    Results Reference
    background
    PubMed Identifier
    28882374
    Citation
    Yuan C, Zhang H, Liu H, Gu J. Does concomitant ulnar styloid fracture and distal radius fracture portend poorer outcomes? A meta-analysis of comparative studies. Injury. 2017 Nov;48(11):2575-2581. doi: 10.1016/j.injury.2017.08.061. Epub 2017 Aug 31.
    Results Reference
    background
    PubMed Identifier
    31956020
    Citation
    Yong J, MacDermid JC, Packham T. Defining dexterity-Untangling the discourse in clinical practice. J Hand Ther. 2020 Oct-Dec;33(4):517-519. doi: 10.1016/j.jht.2019.11.001. Epub 2020 Jan 16. No abstract available.
    Results Reference
    background

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    Manual Dexterity in Ulnar Styloid Fracture Patients

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