Comparison of Two Volar Plating Systems for Distal Radius Fractures
NCT ID: NCT03474445
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
106 participants
INTERVENTIONAL
2017-03-01
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture
NCT01904084
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
NCT01034943
Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
NCT03635060
Volar Plate vs. Conventus DRS Fixation
NCT02390856
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?
NCT06343467
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Envelopes will be prepared containing equal number of cards representing either the conventional or the novel plating syste. On the morning of the surgery a randomly picked envelope decides allocation one of the study groups. Patients will be blinded to treatment until completion of the study. Patients allocated to the control group receive Aptus 2.5® volar plate for distal radius fractures (Medartis AG, Basel, Switzerland), while patients in the study group will receive the plating system INTEOS 2.5® (Hofer GmbH and Co KG, Austria). In the control group, the pronator quadratus muscle will be cut prior mounting of the plate, while in the treatment group the plate will be inserted underneath the pronator quadratus leaving the muscle intact.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
Volar Plate Osteosynthesis Aptus 2.5
Volar Plate Osteosynthesis Aptus 2.5
Volar plating of distal radius fracture. Device: Aptus 2.5
Study Group
Volar Plate Osteosynthesis Inteos 2.5
Volar Plate Osteosynthesis Inteos 2.5
Volar plating of distal radius fracture. Device: Inteos 2.5
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Volar Plate Osteosynthesis Aptus 2.5
Volar plating of distal radius fracture. Device: Aptus 2.5
Volar Plate Osteosynthesis Inteos 2.5
Volar plating of distal radius fracture. Device: Inteos 2.5
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Haider
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Haider, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Universtiy of Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Thalhammer G, Hruby LA, Dangl T, Liebe J, Erhart J, Haider T. Does the pronator-sparing approach improve functional outcome, compared to a standard volar approach, in volar plating of distal radius fractures? A prospective, randomized controlled trial. J Orthop Traumatol. 2023 Apr 28;24(1):16. doi: 10.1186/s10195-023-00700-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2339/2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.