Metatarsal FractureFOOTNCT05450107
Fifth Metatarsal Orthopedic Outcome Trial
A study testing Open Reduction Internal Fixation and Cast immobilisation in people with Metatarsal Fracture, run by Isala at 3 sites in Netherlands.
Trial summary
Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metatarsal Fracture
- What is being tested?
- Open Reduction Internal Fixation and Cast immobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Sep 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older at the time of study entry
- Informed consent
- Competent to participate in follow up and fill out questionnaires
- Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C
Who cannot join
- Open fracture
- Proximal fifth metatarsal fracture, Jones fracture
- Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
- Former surgery or history of development disorder of the contralateral fifth metatarsal
- Multiple fractured metatarsals in the affected foot
- Medical history of Rheumatoid Arthritis
- Unable to undergo surgical procedure
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate ziekenhuis
Arnhem, Gelderland, 6815AD
Annika Willems, 088005888, orthopedicresearch@rijnstate.nl
- Recruiting
Martini ziekenhuis
Groningen, 9728NT
Astrid De Vries, PhD, 0505245960, A.deVries3@mzh.nl
- Recruiting
IsalaK
Zwolle, Overijssel, 8025AB
Maarten Cornelissen, MD, 0886248117, onderzoek.orthopedie@isala.nl
Roeliena Munnik-Hagewoud, PhD, 0886245375, r.munnik@isala.nl
About this study
Official title: Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial
Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment
Read the detailed description
Objective: The main objective is to determine experienced pain, as measured by NRS-11 score, 3 months after intervention and compare this between the intervention and control group. Secondary objectives are functional outcome as measured by AOFAS Lesser Toe Scale, FAAM score, progress of NRS-11 score through time and PROMIS Mobility/pain interference. Furthermore, quality and duration of fracture healing will be compared between groups. The impact on daily life will be compared as measured by duration of return to work and normal footwear.
Study design: Randomised controlled clinical intervention trial
Study population: Humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.
- Conditions
- Metatarsal Fracture
- Being tested
- Open Reduction Internal Fixation, Cast immobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction Internal FixationProcedure or surgery
Surgical intervention by lag screw or plate fixation
Cast immobilisationProcedure or surgery
Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group is offered surgical treatment of the shaft fracture of the fifth metatarsal bone with ORIF. Depending on the type of shaft fracture this will be either lag screw fixation or plate fixation. After surgery a period of cast immobilisation with gradual increase of weight bearing will commence Receives: Procedure: Open Reduction Internal Fixation |
| Control | Active comparator | The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol. Receives: Procedure: Cast immobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale-11 score for pain 3 months
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome
Measured: 3 months after intervention
Secondary outcomes (9)
Numerical rating scale-11 score for pain through time
Numerical Rating Scale-11 score progression through different time points (6 weeks, 3,6 and 12 months after intervention. Score ranging from 0-10. A Higher score is a worse outcome
Measured: 0-12 months after intervention
American Orthopedic Foot &Ankle Society Lesser Toe Scale
American Orthopedic Foot \&Ankle Society Lesser Toe Scale between groups, functional outcome measure for patients with lesser toe (i.e. excluding hallux) and midfoot pathology. Score ranging from 0-100. A Higher score is a better outcome
Measured: 3 months after intervention
Foot and Ankle Ability Measure
Foot and Ankle Ability Measure, a score with two subscales: Activities of Daily Living (ADL) and sports. The questions concern function of the foot and ankle. progression through different time points (6 weeks, 3,6 and 12 months after intervention). Score ranging from 0-120. A higher score is a better outcome
Measured: 6 weeks, 3,6 and 12 months after intervention
Patient Reported Outcome Measure Information System - Mobility
patient reported outcome measures by using Computer Adaptive Testing. Results in a normalized score ranging from 0-100 where an average human being will score 50. Higher score is a better outcome.
Measured: 6 weeks, 3,6 and 12 months after intervention
Patient Reported Outcome Measure Information System - Pain Interference
Patient reported outcome measures by using Computer Adaptive Testing. Results in a normalized score ranging from 0-100 where an average human being will score 50. Higher score is a better outcome.
Measured: 6 weeks, 3,6 and 12 months after intervention
Return to work
Duration of resumption of work
Measured: 0-12 months
Return to normal footwear
Duration of return to normal footwear
Measured: 0-12 months
Malunion
Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal
Measured: 6 weeks after intervention
Non union
Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Sep 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsal FractureStudies 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
- Model description
- Randomized controlled clinical intervention trial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten Cornelissen, Isala
- Investigators
- Rutger Zuurmond, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450107
- Sponsor's protocol ID
- 80748.075.22
- Acronym
- FOOT
- Status last verified
- Feb 2023
- First submitted
- 4 Jul 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05450107
- Acronym / sponsor ID
- FOOT / 80748.075.22
- Conditions
- Metatarsal Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jul 2022 (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.
Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment
Detailed description
Objective: The main objective is to determine experienced pain, as measured by NRS-11 score, 3 months after intervention and compare this between the intervention and control group. Secondary objectives are functional outcome as measured by AOFAS Lesser Toe Scale, FAAM score, progress of NRS-11 score through time and PROMIS Mobility/pain interference. Furthermore, quality and duration of fracture healing will be compared between groups. The impact on daily life will be compared as measured by duration of return to work and normal footwear.
Study design: Randomised controlled clinical intervention trial
Study population: Humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical intervention trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Open Reduction Internal FixationThe intervention group is offered surgical treatment of the shaft fracture of the fifth metatarsal bone with ORIF. Depending on the type of shaft fracture this will be either lag screw fixation or plate fixation. After surgery a period of cast immobilisation with gradual increase of weight bearing will commence |
| Control | Active comparator | Procedure: Cast immobilisationThe control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older at the time of study entry
- Informed consent
- Competent to participate in follow up and fill out questionnaires
- Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C
Key exclusion criteria (7 listed)
- Open fracture
- Proximal fifth metatarsal fracture, Jones fracture
- Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
- Former surgery or history of development disorder of the contralateral fifth metatarsal
- Multiple fractured metatarsals in the affected foot
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 |
|---|---|---|
| Open Reduction Internal FixationSurgical intervention by lag screw or plate fixation | Procedure or surgery | Intervention |
| Cast immobilisationCast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks | Procedure or surgery | Control |
Primary outcome
Numerical rating scale-11 score for pain 3 months
Time frame: 3 months after intervention
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome
9 secondary outcomes
Numerical rating scale-11 score for pain through time
Time frame: 0-12 months after intervention
American Orthopedic Foot &Ankle Society Lesser Toe Scale
Time frame: 3 months after intervention
Foot and Ankle Ability Measure
Time frame: 6 weeks, 3,6 and 12 months after intervention
Patient Reported Outcome Measure Information System - Mobility
Time frame: 6 weeks, 3,6 and 12 months after intervention
Patient Reported Outcome Measure Information System - Pain Interference
Time frame: 6 weeks, 3,6 and 12 months after intervention
Return to work
Time frame: 0-12 months
Return to normal footwear
Time frame: 0-12 months
Malunion
Time frame: 6 weeks after intervention
Non union
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Rutger Zuurmond, MD, PhD principal investigator
Isala
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction Internal Fixation and Cast immobilisation in people with Metatarsal Fracture, run by Isala at 3 sites 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 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Cornelissen, MD (0886248117, m.p.cornelissen@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale-11 score for pain 3 months (time frame: 3 months after 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 2 Mar 2023.