Radius Distal FractureNCT07008430
Angle Specific Torque Profiles After Distal Radius Fracture
An observational study of Radius Distal Fracture, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Distal radius fracture (DRF) is one of the most common upper extremity injuries and can lead to long-term kinesiological and anatomical alterations despite proper surgical fixation and rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radius Distal Fracture
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with distal radius fracture
Who may be able to join
- Patients with distal radius fractures reduced with a volar plate will be included.
Who cannot join
- Patients with bilateral injuries, fractures in bones other than the radius, stabilization methods other than volar plate, and any other neurological or orthopedic condition that may affect the evaluation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University
Izmir, Çiğli, 35620
About this study
Official title: Angle-Specific Torque Profiles of Wrist, Forearm and Elbow Movements After Distal Radius Fracture
Distal radius fracture (DRF) is one of the most common upper extremity injuries and can lead to long-term kinesiological and anatomical alterations despite proper surgical fixation and rehabilitation. This retrospective cohort study aims to analyze the angle-specific torque characteristics of wrist (flexion/extension), forearm (supination/pronation), and elbow (flexion/extension) movements in patients with a history of DRF treated by volar plate fixation.
The study will utilize archived raw data of 37 eligible patients who underwent isokinetic strength testing during the post-rehabilitation period. Data will be extracted from Cybex NORM® and Humac isokinetic dynamometer systems and analyzed using Statistical Parametric Mapping (SPM) with the open-source spm1d package in MATLAB. This analysis will generate 101-point angle-dependent torque curves for each joint movement and will be used to evaluate interlimb asymmetry, angle of peak torque production, and unilateral agonist/antagonist torque ratios.
Read more
Additionally, radiographic images archived during the treatment period will be analyzed to measure radial inclination, palmar tilt, and ulnar variance using the Dresdner scoring system. The torque profiles and radiological parameters will be statistically analyzed with SPSS. Between-limb comparisons and symmetry indices will be calculated using repeated-measures ANOVA, t-tests or non-parametric alternatives, depending on data distribution.
This research is expected to provide new insights into the kinesiological consequences of DRF by presenting detailed angle-specific torque characteristics, going beyond conventional peak torque and range of motion assessments commonly seen in the literature.
- Conditions
- Radius Distal Fracture
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
There will be no intervention. Only archival data will be analyzed
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle Specific Torque Profiles
Raw data files of both the injured and uninjured upper limbs of eligible patients will be obtained from the system records of the isokinetic dynamometer. These raw data will be analyzed using the open-source spm1d package within the MATLAB software (R2021b, The MathWorks Inc., Natick, MA) through statistical parametric mapping (SPM). Accordingly, torque/angle data produced during the full range of motion on the isokinetic dynamometer will be divided into 101 intervals to construct angle-dependent torque profiles (SPM analysis) for each movement.
SPM analysis will be conducted for wrist flexors and extensors, forearm supinators and pronators, and elbow flexors and extensors. Through this analysis, the following parameters will be examined: the angle-dependent torque characteristics of the injured and uninjured limbs, the unilateral angle-dependent agonist/antagonist torque profiles, and the angle at which peak torque occurs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Distal FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış SEVEN, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008430
- Sponsor's protocol ID
- 8
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angle-Specific Torque Profiles of Wrist, Forearm and Elbow Movements After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT07008430
- Acronym / sponsor ID
- 8
- Conditions
- Radius Distal Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Jun 2025 (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.
Distal radius fracture (DRF) is one of the most common upper extremity injuries and can lead to long-term kinesiological and anatomical alterations despite proper surgical fixation and rehabilitation. This retrospective cohort study aims to analyze the angle-specific torque characteristics of wrist (flexion/extension), forearm (supination/pronation), and elbow (flexion/extension) movements in patients with a history of DRF treated by volar plate fixation.
The study will utilize archived raw data of 37 eligible patients who underwent isokinetic strength testing during the post-rehabilitation period. Data will be extracted from Cybex NORM® and Humac isokinetic dynamometer systems and analyzed using Statistical Parametric Mapping (SPM) with the open-source spm1d package in MATLAB. This analysis will generate 101-point angle-dependent torque curves for each joint movement and will be used to evaluate interlimb asymmetry, angle of peak torque production, and unilateral agonist/antagonist torque ratios.
Additionally, radiographic images archived during the treatment period will be analyzed to measure radial inclination, palmar tilt, and ulnar variance using the Dresdner scoring system. The torque profiles and radiological parameters will be statistically analyzed with SPSS. Between-limb comparisons and symmetry indices will be calculated using repeated-measures ANOVA, t-tests or non-parametric alternatives, depending on data distribution.
This research is expected to provide new insights into the kinesiological consequences of DRF by presenting detailed angle-specific torque characteristics, going beyond conventional peak torque and range of motion assessments commonly seen in the literature.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with distal radius fracture
Key inclusion criteria (1 listed)
- Patients with distal radius fractures reduced with a volar plate will be included.
Key exclusion criteria (1 listed)
- Patients with bilateral injuries, fractures in bones other than the radius, stabilization methods other than volar plate, and any other neurological or orthopedic condition that may affect the evaluation will be excluded from the study.
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 |
|---|---|---|
| No Intervention: Observational CohortThere will be no intervention. Only archival data will be analyzed | Other | – |
Primary outcome
Angle Specific Torque Profiles
Time frame: 1 year
Raw data files of both the injured and uninjured upper limbs of eligible patients will be obtained from the system records of the isokinetic dynamometer. These raw data will be analyzed using the open-source spm1d package within the MATLAB software (R2021b, The MathWorks Inc., Natick, MA) through statistical parametric mapping (SPM). Accordingly, torque/angle data produced during the full range of motion on the isokinetic dynamometer will be divided into 101 intervals to construct angle-dependent torque profiles (SPM analysis) for each movement. SPM analysis will be conducted for wrist flexors and extensors, forearm supinators and pronators, and elbow flexors and extensors. Through this analysis, the following parameters will be examined: the angle-dependent torque characteristics of the injured and uninjured limbs, the unilateral angle-dependent agonist/antagonist torque profiles, and the angle at which peak torque occurs.
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 6 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Radius Distal Fracture
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Distal Fracture, run by Gazi University at 1 site in Turkey (Türkiye).
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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Angle Specific Torque Profiles (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.