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
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
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
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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