Radius Distal FractureNCT03716661
Operative vs. Conservative Treatment of Distal Radius Fractures
A study testing ORIF in people with Radius Distal Fracture and Distal Radius Fracture, run by University of Aarhus at 1 site in Denmark.
Trial summary
Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Radius Distal Fracture, Distal Radius Fracture, Radius Fracture Distal
- What is being tested?
- ORIF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2018to 1 Apr 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Danish National Guidelines for operative treatment of distal radius fractures
Who cannot join
- Patients treated with plaster in Arm1/control group who unexpectedly requires surgery
Trial locations and contacts
1 site in 1 country.
About this study
Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.
- Being tested
- ORIF
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIFProcedure or surgery
Open Reduction Internal Fixation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines. |
| Conservative | No intervention | Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 2: Patients randomized to conservative plaster treatment |
| Operative | Other | Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines.
Arm 3: Patients randomized to operative treatment (ORIF) Receives: Procedure: ORIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related complications at baseline
Measured: Baseline
Change in number of participants with treatment-related complications from baseline at week 2
Measured: Week 2
Change in number of participants with treatment-related complications from baseline at week 5
Measured: Week 5
Change in number of participants with treatment-related complications from baseline at month 6
Measured: Month 6
Change in number of participants with treatment-related complications from baseline at 1 year
Measured: 1 Year
Range of motion of the wrist at week 5
- Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Measured: Week 5
Change in range of motion of the wrist from week 5 at month 6
- Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Measured: Month 6
Change in range of motion of the wrist from month 6 at 1 year
- Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Measured: 1 Year
Level of functioning at baseline
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Measured: Baseline
Change in level of functioning from baseline at week 2
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Measured: Week 2
Change in level of functioning from baseline at week 5
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Measured: Week 5
Change in level of functioning from baseline at month 6
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Measured: Month 6
Change in level of functioning from baseline at 1 year
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radius Distal FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716661
- Sponsor's protocol ID
- 1-10-72-420-17
- Status last verified
- May 2022
- First submitted
- 5 Oct 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. Prospective Evaluation of Two Cohorts of Non-Operatively Treated Patients with Displaced vs. Minimally and Non-Displaced Distal Radius Fractures. J Clin Med. 2023 Mar 6;12(5):2076. doi: 10.3390/jcm12052076.
PubMed 36902861Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years. J Orthop Traumatol. 2022 Nov 28;23(1):54. doi: 10.1186/s10195-022-00673-4.
PubMed 36443579Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.
PubMed 31253145
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative vs. Conservative Treatment of Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT03716661
- Acronym / sponsor ID
- 1-10-72-420-17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 23 Oct 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.
Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines. |
| Conservative | No intervention | –Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 2: Patients randomized to conservative plaster treatment |
| Operative | Other | Procedure: ORIFArm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 3: Patients randomized to operative treatment (ORIF) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Danish National Guidelines for operative treatment of distal radius fractures
Key exclusion criteria (1 listed)
- Patients treated with plaster in Arm1/control group who unexpectedly requires surgery
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 |
|---|---|---|
| ORIFOpen Reduction Internal Fixation | Procedure or surgery | Operative |
Primary outcome
Number of participants with treatment-related complications at baseline
Time frame: Baseline
Change in number of participants with treatment-related complications from baseline at week 2
Time frame: Week 2
Change in number of participants with treatment-related complications from baseline at week 5
Time frame: Week 5
Change in number of participants with treatment-related complications from baseline at month 6
Time frame: Month 6
Change in number of participants with treatment-related complications from baseline at 1 year
Time frame: 1 Year
Range of motion of the wrist at week 5
Time frame: Week 5
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Change in range of motion of the wrist from week 5 at month 6
Time frame: Month 6
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Change in range of motion of the wrist from month 6 at 1 year
Time frame: 1 Year
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Level of functioning at baseline
Time frame: Baseline
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 2
Time frame: Week 2
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 5
Time frame: Week 5
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at month 6
Time frame: Month 6
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at 1 year
Time frame: 1 Year
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
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 10 Aug 2022.
- Derived from this study: PubMed 36902861Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. Prospective Evaluation of Two Cohorts of Non-Operatively Treated Patients with Displaced vs. Minimally and Non-Displaced Distal Radius Fractures. J Clin Med. 2023 Mar 6;12(5):2076. doi: 10.3390/jcm12052076.
- Derived from this study: PubMed 36443579Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years. J Orthop Traumatol. 2022 Nov 28;23(1):54. doi: 10.1186/s10195-022-00673-4.
- Derived from this study: PubMed 31253145Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF in people with Radius Distal Fracture and Distal Radius Fracture, run by University of Aarhus at 1 site in Denmark.
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 10 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 Denmark. 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?
Number of participants with treatment-related complications at baseline (time frame: Baseline). The study lists 13 primary outcomes in all. 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 NCT03716661, which also lists 3 linked publications.
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 10 Aug 2022.