Clinical trial NCT03474445: Comparison of Two Volar Plating Systems for Distal Radius Fractures
Official title: Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient rated wrist evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Mayo wrist score
timeFrame: 8 weeks, 3 months, 6 months, 12 months
measure: Radiological Outcome
timeFrame: 2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months
measure: strength measurement
timeFrame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
measure: Volumetric evaluation
timeFrame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
measure: Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH
timeFrame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
measure: Patient rated wrist evaluation
timeFrame: 4 weeks, 8 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical Universtiy of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Haider, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: