An interventional study of Volar Plate Osteosynthesis Aptus 2.5 and Volar Plate Osteosynthesis Inteos 2.5 in Distal Radius Fracture, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a prospective single-blinded controlled clinical trial.
This study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures.
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.
329 studies on the registry are indexed under Wrist Fractures; 69 are open to participants now.
This study's enrollment of 106 is above the median of 63 across 267 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
Volar Plate Osteosynthesis Aptus 2.5
Procedure: Volar Plate Osteosynthesis Aptus 2.5
Volar Plate Osteosynthesis Inteos 2.5
Procedure: Volar Plate Osteosynthesis Inteos 2.5
Volar plating of distal radius fracture. Device: Aptus 2.5
Also known as: Henry approach, cutting of pronator quadratus
Volar plating of distal radius fracture. Device: Inteos 2.5
Also known as: Henry approach, preservation of pronator quadratus
Patient rated wrist evaluation
Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
Time frame: 12 months
Mayo wrist score
Function-based evaluation of the wrist, range 0-100, 90-100=very good, 80-89=good, 65-79=satisfying, \<65=poor
Time frame: 8 weeks, 3 months, 6 months, 12 months
Radiological Outcome
x-ray based outcome of plate osteosynthesis (including ap and volar inclination angles, joint congruency, ulna length). Measurements will be performed on digitalised radiographs with IMPAX viewer (Agfa Ges.m.bH)
Time frame: 2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months
strength measurement
dynamometer-based strength evaluation
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Volumetric evaluation
With a standardised device using water displacement wirst swelling will be assessed.
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH
patient-based standardised questionnaire, 30 items, range 0-100, 0=best outcome, 100=worst outcome
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Patient rated wrist evaluation
Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
Time frame: 4 weeks, 8 weeks, 3 months, 6 months
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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