Lateral Malleolus FracturesNCT01758835
PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.
A study testing Splint 3 weeks, Cast 3 weeks and Cast 6 weeks in people with Lateral Malleolus Fractures, run by University of Oulu at 1 site in Finland.
Trial summary
PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lateral Malleolus Fractures
- What is being tested?
- Splint 3 weeks, Cast 3 weeks and Cast 6 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to Dec 2017
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stable Weber-B type fibula fracture
- ER-stress negative
- 16 or over years old
- Willingness to participate on study proved by a signature and date
- Walking without aid before accident
- Treatment started within 7 days from injury
Who cannot join
- Prior ankle fracture or significant fracture in the area of ankle or leg
- Bilateral ankle fracture
- Pathological fracture
- Diabetes mellitus or an other significant periferial neuropathy
- municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
- Patient's understanding or co-operation inadequate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Read the detailed description
Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
- Conditions
- Lateral Malleolus Fractures
- Being tested
- Splint 3 weeks, Cast 3 weeks, Cast 6 weeks
- Keywords
- ER-stress-test negative, unimalleolar, fibula, Weber-B fractures
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splint 3 weeksOther
A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.
Cast 3 weeksOther
A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.
Cast 6 weeksOther
standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.
| Study group | Role | What they receive |
|---|---|---|
| Splint 3 weeks | Active comparator | Removable ankle brace/splint Receives: Other: Splint 3 weeks |
| Cast 3 weeks | Active comparator | Below-the-knee cast (glass fiber) Receives: Other: Cast 3 weeks |
| Cast 6 weeks | Active comparator | Below-the-knee cast (glass fiber) Receives: Other: Cast 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud-Molander score
Ankle functional outcome measure
Measured: 1 year
Secondary outcomes (4)
FAOS
Foot and Ankle Outcome Score
Measured: 1 year
VAS
Visual Analogue Scale pain and function
Measured: 1 year
RAND 36 Health item survey
Quality of life measurement
Measured: 1 year
Fracture healing
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 posted1 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionDec 2017
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 Lateral Malleolus FracturesStudies 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
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Harri Pakarinen, University of Oulu
- Investigators
- Harri J Pakarinen, MD, PhD, Study director, Oulu University HospitalTero HJ Kortekangas, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758835
- Sponsor's protocol ID
- OYSrctAnkle5
- Status last verified
- Oct 2018
- First submitted
- 21 Dec 2012
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.
PubMed 30674451
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
- ClinicalTrials.gov ID
- NCT01758835
- Acronym / sponsor ID
- OYSrctAnkle5
- Conditions
- Lateral Malleolus Fractures
- Keywords
- ER-stress-test negative, unimalleolar, fibula, Weber-B fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Jan 2013 (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.
PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Detailed description
Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Splint 3 weeks | Active comparator | Other: Splint 3 weeksRemovable ankle brace/splint |
| Cast 3 weeks | Active comparator | Other: Cast 3 weeksBelow-the-knee cast (glass fiber) |
| Cast 6 weeks | Active comparator | Other: Cast 6 weeksBelow-the-knee cast (glass fiber) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Stable Weber-B type fibula fracture
- ER-stress negative
- 16 or over years old
- Willingness to participate on study proved by a signature and date
- Walking without aid before accident
Key exclusion criteria (6 listed)
- Prior ankle fracture or significant fracture in the area of ankle or leg
- Bilateral ankle fracture
- Pathological fracture
- Diabetes mellitus or an other significant periferial neuropathy
- municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
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 |
|---|---|---|
| Splint 3 weeksA removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal. | Other | Splint 3 weeks |
| Cast 3 weeksA standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal. | Other | Cast 3 weeks |
| Cast 6 weeksstandard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal. | Other | Cast 6 weeks |
Primary outcome
Olerud-Molander score
Time frame: 1 year
Ankle functional outcome measure
4 secondary outcomes
FAOS
Time frame: 1 year
VAS
Time frame: 1 year
RAND 36 Health item survey
Time frame: 1 year
Fracture healing
Time frame: 1 year
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 18 Oct 2018.
- Derived from this study: PubMed 30674451Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.
- 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.
Harri J Pakarinen, MD, PhD study director
Oulu University Hospital
Tero HJ Kortekangas, MD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint 3 weeks, Cast 3 weeks and Cast 6 weeks in people with Lateral Malleolus Fractures, run by University of Oulu at 1 site in Finland.
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 6 inclusion and 6 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 18 Oct 2018. 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 Finland. 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?
Olerud-Molander score (time frame: 1 year). 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 NCT01758835, 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 18 Oct 2018.