NCT04357470

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

Keywords

DISTAL RADIUS FRACTUREULNAR STYLOID FRACTUREMANUAL DEXTERITY

Outcome Measures

Primary Outcomes (6)

  • Pain

    The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity

    six month

  • Range of motion

    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

    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)

    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

    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

    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

Study Arms (2)

USF Group

ACTIVE COMPARATOR

DRF with ulnar styloid fracture

Other: Hand Therapy

NON-USF Group

ACTIVE COMPARATOR

DRF without ulnar styloid fracture

Other: Hand Therapy

Interventions

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.

Also known as: Rehabilitation
NON-USF GroupUSF Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29576925BACKGROUND
  • 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.

    PMID: 28882374BACKGROUND
  • 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.

    PMID: 31956020BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • HANDE USTA, MSC

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Research Assistant

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

October 12, 2016

Primary Completion

September 14, 2019

Study Completion

March 20, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share