Comparison of Two Volar Plating Systems for Distal Radius Fractures
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
- " Distal radius fracture, Type A2, A3, B1, B2, B3, C1, C2 (according to AO Müller classification3) " Patient age between 18 and 75 years " Closed fracture or I° open fractures (according to Gustilo-Anderson classification6) " Agreement of patient to participate and written informed consent
Exclusion criteria
- " Polytraumatized patients " Severe systemic disorder (ASA 3) " New and/or preexisting fracture/Injury of contralateral forearm " II° and III° open fractures (according to Gustilo-Anderson classification6) " Associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " Non-compliance to postoperative protocol (e.g. physiotherapy) " Delayed definitive surgical treatment of more than 14 days after injury " Change from temporary procedure (e.g. Fixateur externe) " Complex regional pain syndrome (CRPS, M.Sudeck) " Loss to follow-up
Trial design
Primary purpose
Allocation
Interventional model
Masking
106 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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