Ankle FracturesNCT03377205
Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
A study testing Compression screws and neutralization plate and Acumed Fibular Rod System in people with Ankle Fractures, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Compression screws and neutralization plate and Acumed Fibular Rod System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2016to Jan 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
- Operable with both methods of surgery within 3 weeks after injury.
- Men and women ≥ 60 yoa.
Who cannot join
- Prior injury or pathology with reduced ankle function.
- Other acute foot/ankle/leg injury that will affect ankle function.
- Fracture of the posterior malleolus that need fixation.
- Injury / pathology that may affect rehabilitation.
- Open fracture.
- Inoperable patient.
- Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.
Read the detailed description
Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.
- Conditions
- Ankle Fractures
- Being tested
- Compression screws and neutralization plate, Acumed Fibular Rod System
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression screws and neutralization plateDevice
Open reduction and internal fixation with screws and plate
Acumed Fibular Rod SystemDevice
intramedullary nailing of fibula
| Study group | Role | What they receive |
|---|---|---|
| Plate | Active comparator | Compression screws and neutralization plate. Receives: Device: Compression screws and neutralization plate |
| Intramedullary nail | Experimental | Acumed Fibular Rod System Receives: Device: Acumed Fibular Rod System |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopaedic Foot and Ankle Society (AOFAS) score
Functional outcome as assessed by AOFAS score (0-100)
Measured: 5 years
Secondary outcomes (11)
Manchester-Oxford Foot questionnaire (MOxFQ)
Patient reported outcome as assessed by MOxFQ (0-100)
Measured: 5 years
Olerud and Molander Score (OMS)
Patient reported outcome as assessed by OMS (0-100)
Measured: 5 years
EuroQol-5d (Eq-5d)
Patient reported quality of life as assessed by Eq-5d index score
Measured: 5 years
Visual analogue scale (VAS)
VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best
Measured: 5 years
Fracture reduction as assessed by CT scans
Number of patients with good, fair or poor fracture reduction
Measured: 3 months
Malunion as assessed by CT scans
Number of patients with malunion
Measured: 5 years
Nonunion as assessed by CT scans
Number of patients with nonunion
Measured: 5 years
Osteoarthritis as assessed by CT scans
Number of patients with osteoarthritis assessed according to the criteria by McLennan et al
Measured: 5 years
Infection
Number of patients with wound infection or deep infection
Measured: 3 months
Delayed wound healing
Number of patients with delayed wound healing
Measured: 3 months
Other complications
Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startJun 2016
- Primary completionJun 2021
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ostfold Hospital Trust, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Elisabeth Ellingsen Husebye, Oslo University Hospital
- Investigators
- Elisabeth E Husebye, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377205
- Sponsor's protocol ID
- 2016/137 (REK)
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2017
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
- ClinicalTrials.gov ID
- NCT03377205
- Acronym / sponsor ID
- 2016/137 (REK)
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Ostfold Hospital Trust, Vestre Viken Hospital Trust
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Dec 2017 (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.
The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.
Detailed description
Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plate | Active comparator | Device: Compression screws and neutralization plateCompression screws and neutralization plate. |
| Intramedullary nail | Experimental | Device: Acumed Fibular Rod SystemAcumed Fibular Rod System |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
- Operable with both methods of surgery within 3 weeks after injury.
- Men and women ≥ 60 yoa.
Key exclusion criteria (7 listed)
- Prior injury or pathology with reduced ankle function.
- Other acute foot/ankle/leg injury that will affect ankle function.
- Fracture of the posterior malleolus that need fixation.
- Injury / pathology that may affect rehabilitation.
- Open fracture.
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 |
|---|---|---|
| Compression screws and neutralization plateOpen reduction and internal fixation with screws and plate | Device | Plate |
| Acumed Fibular Rod Systemintramedullary nailing of fibula | Device | Intramedullary nail |
Primary outcome
American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: 5 years
Functional outcome as assessed by AOFAS score (0-100)
11 secondary outcomes
Manchester-Oxford Foot questionnaire (MOxFQ)
Time frame: 5 years
Olerud and Molander Score (OMS)
Time frame: 5 years
EuroQol-5d (Eq-5d)
Time frame: 5 years
Visual analogue scale (VAS)
Time frame: 5 years
Fracture reduction as assessed by CT scans
Time frame: 3 months
Malunion as assessed by CT scans
Time frame: 5 years
Nonunion as assessed by CT scans
Time frame: 5 years
Osteoarthritis as assessed by CT scans
Time frame: 5 years
Infection
Time frame: 3 months
Delayed wound healing
Time frame: 3 months
Other complications
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- 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.
Elisabeth E Husebye, MD, PhD study chair
Oslo 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 Compression screws and neutralization plate and Acumed Fibular Rod System in people with Ankle Fractures, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 7 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 13 Jul 2023. 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 Norway. 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?
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?
American Orthopaedic Foot and Ankle Society (AOFAS) score (time frame: 5 years). 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 13 Jul 2023.