Orthopedic DisorderNCT04655768
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
A study testing Palmar Plate Fixation in people with Orthopedic Disorder, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment. A randomized prospective trial is palnned Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Palmar Plate Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2020to 31 Dec 2024
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Radius Fractures C1-C2
- age over 70
Who cannot join
- demetia
- collateral damages
- age < 70
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, Upper Austria, 4020
Stefan M Froschauer, MD, 004373278061020, stefan.froschauer@kepleruniklinikum.at
Stefan M Froschauer, MD
About this study
Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment.
A randomized prospective trial is palnned
Read the detailed description
Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment.
Primary aim is PRWE, secondary ROM as well as power and DASH score.
- Conditions
- Orthopedic Disorder
- Being tested
- Palmar Plate Fixation
- Keywords
- radius fracture, clinical outcome
- Medical subject headings
- Musculoskeletal Diseases, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmar Plate FixationDevice
Patients are treated by surgery (palmar plate)
| Study group | Role | What they receive |
|---|---|---|
| Operative Arm | Active comparator | Radius fractures C1/C2 treated by palmar plate fixation Receives: Device: Palmar Plate Fixation |
| Conservative Arm | No intervention | Radius Fractures C1/C2 treated by cast fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Related Wrist Evaulation
PRWE, ROM investigation
Measured: 12-24 months post intervention
Secondary outcomes (1)
ROM
PRWE, ROM, Investigation
Measured: 12-24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan M Froschauer, MD, Study director, Kepler University Hospital Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655768
- Sponsor's protocol ID
- KUK-UNF-20-001
- Status last verified
- Aug 2022
- First submitted
- 30 Nov 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT04655768
- Acronym / sponsor ID
- KUK-UNF-20-001
- Conditions
- Orthopedic Disorder
- Keywords
- radius fracture, clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Dec 2020 (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.
Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment.
A randomized prospective trial is palnned
Detailed description
Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment.
Primary aim is PRWE, secondary ROM as well as power and DASH score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Arm | Active comparator | Device: Palmar Plate FixationRadius fractures C1/C2 treated by palmar plate fixation |
| Conservative Arm | No intervention | –Radius Fractures C1/C2 treated by cast fixation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Radius Fractures C1-C2
- age over 70
Key exclusion criteria (3 listed)
- demetia
- collateral damages
- age < 70
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 |
|---|---|---|
| Palmar Plate FixationPatients are treated by surgery (palmar plate) | Device | Operative Arm |
Primary outcome
Patient Related Wrist Evaulation
Time frame: 12-24 months post intervention
PRWE, ROM investigation
1 secondary outcome
ROM
Time frame: 12-24 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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.
Stefan M Froschauer, MD study director
Kepler University Hospital Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmar Plate Fixation in people with Orthopedic Disorder, run by Kepler University Hospital 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan M Froschauer, MD (+4373278061020, stefan.froschauer@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Related Wrist Evaulation (time frame: 12-24 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2022.