Anke FractureRODEONCT02896998
Routine Versus on Demand Removal of the Syndesmotic Screw
A study testing Removal on demand of the syndesmotic screw and Routine removal of fhe syndesmotic screw in people with Anke Fracture and Syndesmotic Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anke Fracture, Syndesmotic Injury
- What is being tested?
- Removal on demand of the syndesmotic screw and Routine removal of fhe syndesmotic screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to 1 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 17 years of age
- Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
- Syndesmotic screw placed within two weeks of the trauma
- Being in such condition that one is able to possibly undergo a second procedure
Who cannot join
- ISS score >15
- Injuries to the ipsi- and contralateral side which might hamper rehabilitation
- Other medical conditions which hamper physical rehabilitation
- Incomprehensive understanding of the Dutch language
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.
- Conditions
- Anke Fracture, Syndesmotic Injury
- Being tested
- Removal on demand of the syndesmotic screw, Routine removal of fhe syndesmotic screw
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal on demand of the syndesmotic screwProcedure or surgery
The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
Routine removal of fhe syndesmotic screwProcedure or surgery
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw Receives: Procedure: Routine removal of fhe syndesmotic screw |
| Intervention | Experimental | The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion) Receives: Procedure: Removal on demand of the syndesmotic screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome through the Olerud-Moland score
Measured: 1 year following initial treatment
Secondary outcomes (7)
Functional outcome through the OAFAS
Measured: 1 year following initial treatment
Pain through the Visual Analog scale
Measured: 1 year following initial treatment
Range of motion
Measured: 1 year following initial treatment
Surgical complications
Measured: 1 year following initial treatment
Quality of Life through the EQ-5D-5L
Measured: 1 year following initial treatment
Health care consumption through the iMCQ
Measured: 1 year following initial treatment
Loss of productivity through the iPCQ
Measured: 1 year following initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJan 2017
- Primary completion1 May 2020
- Study completion1 May 2020
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 Anke FractureStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896998
- Sponsor's protocol ID
- METC2016_197
- Acronym
- RODEO
- Status last verified
- Jul 2020
- First submitted
- 7 Sep 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dingemans SA, Birnie MFN, Sanders FRK, van den Bekerom MPJ, Backes M, van Beeck E, Bloemers FW, van Dijkman B, Flikweert E, Haverkamp D, Holtslag HR, Hoogendoorn JM, Joosse P, Parkkinen M, Roukema G, Sosef N, Twigt BA, van Veen RN, van der Veen AH, Vermeulen J, Winkelhagen J, van der Zwaard BC, van Dieren S, Goslings JC, Schepers T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial). BMC Musculoskelet Disord. 2018 Jan 31;19(1):35. doi: 10.1186/s12891-018-1946-5.
PubMed 29386053
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus on Demand Removal of the Syndesmotic Screw
- ClinicalTrials.gov ID
- NCT02896998
- Acronym / sponsor ID
- RODEO / METC2016_197
- Conditions
- Anke Fracture, Syndesmotic Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jan 2017
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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.
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: Routine removal of fhe syndesmotic screwThe syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw |
| Intervention | Experimental | Procedure: Removal on demand of the syndesmotic screwThe syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 17 years of age
- Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
- Syndesmotic screw placed within two weeks of the trauma
- Being in such condition that one is able to possibly undergo a second procedure
Key exclusion criteria (4 listed)
- ISS score >15
- Injuries to the ipsi- and contralateral side which might hamper rehabilitation
- Other medical conditions which hamper physical rehabilitation
- Incomprehensive understanding of the Dutch language
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 |
|---|---|---|
| Removal on demand of the syndesmotic screwThe syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion) | Procedure or surgery | Intervention |
| Routine removal of fhe syndesmotic screwThe syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw | Procedure or surgery | Control group |
Primary outcome
Functional outcome through the Olerud-Moland score
Time frame: 1 year following initial treatment
7 secondary outcomes
Functional outcome through the OAFAS
Time frame: 1 year following initial treatment
Pain through the Visual Analog scale
Time frame: 1 year following initial treatment
Range of motion
Time frame: 1 year following initial treatment
Surgical complications
Time frame: 1 year following initial treatment
Quality of Life through the EQ-5D-5L
Time frame: 1 year following initial treatment
Health care consumption through the iMCQ
Time frame: 1 year following initial treatment
Loss of productivity through the iPCQ
Time frame: 1 year following initial treatment
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 Jul 2020.
- Derived from this study: PubMed 29386053Dingemans SA, Birnie MFN, Sanders FRK, van den Bekerom MPJ, Backes M, van Beeck E, Bloemers FW, van Dijkman B, Flikweert E, Haverkamp D, Holtslag HR, Hoogendoorn JM, Joosse P, Parkkinen M, Roukema G, Sosef N, Twigt BA, van Veen RN, van der Veen AH, Vermeulen J, Winkelhagen J, van der Zwaard BC, van Dieren S, Goslings JC, Schepers T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial). BMC Musculoskelet Disord. 2018 Jan 31;19(1):35. doi: 10.1186/s12891-018-1946-5.
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 Removal on demand of the syndesmotic screw and Routine removal of fhe syndesmotic screw in people with Anke Fracture and Syndesmotic Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 4 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 Jul 2020. 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 Netherlands. 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?
Functional outcome through the Olerud-Moland score (time frame: 1 year following initial treatment). 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 NCT02896998, 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 10 Jul 2020.