Ulnar Styloid FractureNCT04357470
Manual Dexterity in Ulnar Styloid Fracture Patients
A study testing Hand Therapy in people with Ulnar Styloid Fracture and Distal Radius Fracture, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulnar Styloid Fracture, Distal Radius Fracture
- What is being tested?
- Hand Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2016to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Ulnar Styloid Fracture, Distal Radius Fracture
- Being tested
- Hand Therapy
- Keywords
- DISTAL RADIUS FRACTURE, ULNAR STYLOID FRACTURE, MANUAL DEXTERITY
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand TherapyOther
Also called Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| USF Group | Active comparator | DRF with ulnar styloid fracture Receives: Other: Hand Therapy |
| NON-USF Group | Active comparator | DRF without ulnar styloid fracture Receives: Other: Hand Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start12 Oct 2016
- Primary completion14 Sep 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulnar Styloid FractureStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
- Investigators
- HANDE USTA, MSC, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357470
- Sponsor's protocol ID
- 60116787020/62810
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29576925Yuan 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.
PubMed 28882374Yong 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.
PubMed 31956020
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulnar Styloid Fracture Accompanying Distal Radius Fracture Does Not Affect Functional Results, But What About Manual Dexterity?
- ClinicalTrials.gov ID
- NCT04357470
- Acronym / sponsor ID
- 60116787020/62810
- Conditions
- Ulnar Styloid Fracture, Distal Radius Fracture
- Keywords
- DISTAL RADIUS FRACTURE, ULNAR STYLOID FRACTURE, MANUAL DEXTERITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 14 Sep 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| USF Group | Active comparator | Other: Hand TherapyDRF with ulnar styloid fracture |
| NON-USF Group | Active comparator | Other: Hand TherapyDRF without ulnar styloid fracture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand TherapyAlso: RehabilitationThe 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 | NON-USF Group, USF Group |
Primary outcome
Pain
Time frame: six month
The severity of pain was assessed with a visual analogue scale (VAS) in sleep, rest, and activity
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Background: PubMed 29576925Almedghio 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.
- Background: PubMed 28882374Yuan 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.
- Background: PubMed 31956020Yong 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HANDE USTA, MSC principal investigator
Research Assistant
Questions about this trial
What is this clinical trial studying?
A study testing Hand Therapy in people with Ulnar Styloid Fracture and Distal Radius Fracture, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: six month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.