Distal Radius FractureNCT03474445
Comparison of Two Volar Plating Systems for Distal Radius Fractures
A study testing Volar Plate Osteosynthesis Aptus 2.5 and Volar Plate Osteosynthesis Inteos 2.5 in people with Distal Radius Fracture, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Volar Plate Osteosynthesis Aptus 2.5 and Volar Plate Osteosynthesis Inteos 2.5
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- " 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
Who cannot join
- " 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Volar Plate Osteosynthesis Aptus 2.5, Volar Plate Osteosynthesis Inteos 2.5
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar Plate Osteosynthesis Aptus 2.5Procedure or surgery
Also called Henry approach, cutting of pronator quadratus
Volar plating of distal radius fracture. Device: Aptus 2.5
Volar Plate Osteosynthesis Inteos 2.5Procedure or surgery
Also called Henry approach, preservation of pronator quadratus
Volar plating of distal radius fracture. Device: Inteos 2.5
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Volar Plate Osteosynthesis Aptus 2.5 Receives: Procedure: Volar Plate Osteosynthesis Aptus 2.5 |
| Study Group | Active comparator | Volar Plate Osteosynthesis Inteos 2.5 Receives: Procedure: Volar Plate Osteosynthesis Inteos 2.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated wrist evaluation
Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
Measured: 12 months
Secondary outcomes (6)
Mayo wrist score
Function-based evaluation of the wrist, range 0-100, 90-100=very good, 80-89=good, 65-79=satisfying, <65=poor
Measured: 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)
Measured: 2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months
strength measurement
dynamometer-based strength evaluation
Measured: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Volumetric evaluation
With a standardised device using water displacement wirst swelling will be assessed.
Measured: 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
Measured: 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
Measured: 4 weeks, 8 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Mar 2017
- Primary completion30 Nov 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Haider, Medical University of Vienna
- Investigators
- Thomas Haider, M.D., Ph.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474445
- Sponsor's protocol ID
- 2339/2016
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37118158
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03474445
- Acronym / sponsor ID
- 2339/2016
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Volar Plate Osteosynthesis Aptus 2.5Volar Plate Osteosynthesis Aptus 2.5 |
| Study Group | Active comparator | Procedure: Volar Plate Osteosynthesis Inteos 2.5Volar Plate Osteosynthesis Inteos 2.5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- " 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
Key exclusion criteria (1 listed)
- " 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volar Plate Osteosynthesis Aptus 2.5Also: Henry approach, cutting of pronator quadratusVolar plating of distal radius fracture. Device: Aptus 2.5 | Procedure or surgery | Control group |
| Volar Plate Osteosynthesis Inteos 2.5Also: Henry approach, preservation of pronator quadratusVolar plating of distal radius fracture. Device: Inteos 2.5 | Procedure or surgery | Study Group |
Primary outcome
Patient rated wrist evaluation
Time frame: 12 months
Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
6 secondary outcomes
Mayo wrist score
Time frame: 8 weeks, 3 months, 6 months, 12 months
Radiological Outcome
Time frame: 2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months
strength measurement
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Volumetric evaluation
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH
Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Patient rated wrist evaluation
Time frame: 4 weeks, 8 weeks, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 37118158Thalhammer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Haider, M.D., Ph.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar Plate Osteosynthesis Aptus 2.5 and Volar Plate Osteosynthesis Inteos 2.5 in people with Distal Radius Fracture, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rated wrist evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03474445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.