- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04357470
Manual Dexterity in Ulnar Styloid Fracture Patients
Ulnar Styloid Fracture Accompanying Distal Radius Fracture Does Not Affect Functional Results, But What About Manual Dexterity?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: USF Group
DRF with ulnar styloid fracture
|
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.
Other Names:
|
Active Comparator: NON-USF Group
DRF without ulnar styloid fracture
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: six month
|
The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity
|
six month
|
Range of motion
Time Frame: six month
|
Patients' forearm and wrist joints ROM (pronation, supination, flexion, extension, radial and ulnar deviation) were measured with an universal goniometer
|
six month
|
Grip and Pinch Strength
Time Frame: six month
|
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
|
six month
|
Quick-The Disabilities of the Arm, Shoulder and Hand (Q-DASH)
Time Frame: six month
|
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
|
six month
|
Purdue Pegboard Test
Time Frame: six month
|
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
|
six month
|
Jebsen Taylor Hand Function Test
Time Frame: six month
|
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
|
six month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HANDE USTA, MSC, Research Assistant
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787020/62810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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