NCT07008430

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

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

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 29, 2025

Last Update Submit

May 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Interventions

There will be no intervention. Only archival data will be analyzed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with distal radius fracture

You may qualify if:

  • Patients with distal radius fractures reduced with a volar plate will be included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

June 6, 2025

Record last verified: 2025-05

Locations