NCT03474445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

4.8 years

First QC Date

March 9, 2018

Last Update Submit

April 4, 2022

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Mayo wrist score

    8 weeks, 3 months, 6 months, 12 months

  • Radiological Outcome

    2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months

  • strength measurement

    4 weeks, 8 weeks, 3 months, 6 months, 12 months

  • Volumetric evaluation

    4 weeks, 8 weeks, 3 months, 6 months, 12 months

  • Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH

    4 weeks, 8 weeks, 3 months, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Volar Plate Osteosynthesis Aptus 2.5

Procedure: Volar Plate Osteosynthesis Aptus 2.5

Study Group

ACTIVE COMPARATOR

Volar Plate Osteosynthesis Inteos 2.5

Procedure: Volar Plate Osteosynthesis Inteos 2.5

Interventions

Volar Plate Osteosynthesis Aptus 2.5PROCEDURE

Volar plating of distal radius fracture. Device: Aptus 2.5

Also known as: Henry approach, cutting of pronator quadratus
Control group
Volar Plate Osteosynthesis Inteos 2.5PROCEDURE

Volar plating of distal radius fracture. Device: Inteos 2.5

Also known as: Henry approach, preservation of pronator quadratus
Study Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • " 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

You may not qualify if:

  • " 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Universtiy of Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 37118158DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Thomas Haider, M.D., Ph.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 22, 2018

Study Start

March 1, 2017

Primary Completion

November 30, 2021

Study Completion

February 28, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)