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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Volar Plate Osteosynthesis Aptus 2.5 |
|
| Study Group | Active Comparator | Volar Plate Osteosynthesis Inteos 2.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volar Plate Osteosynthesis Aptus 2.5 | Procedure | Volar plating of distal radius fracture. Device: Aptus 2.5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient rated wrist evaluation | Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo wrist score | Function-based evaluation of the wrist, range 0-100, 90-100=very good, 80-89=good, 65-79=satisfying, <65=poor | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Haider, M.D., Ph.D. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Universtiy of Vienna | Vienna | A-1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37118158 | Derived | 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. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Volar Plate Osteosynthesis Inteos 2.5 | Procedure | Volar plating of distal radius fracture. Device: Inteos 2.5 |
|
|
| 2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months |
| strength measurement | dynamometer-based strength evaluation | 4 weeks, 8 weeks, 3 months, 6 months, 12 months |
| Volumetric evaluation | With a standardised device using water displacement wirst swelling will be assessed. | 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 | 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 | 4 weeks, 8 weeks, 3 months, 6 months |