Fractures, StressNCT04847115
Treatment of Fifth Metatarsal Zone 3 Fractures
A study testing Operative and Walking boot orthosis in people with Fractures, Stress and Metatarsal Fracture, run by Ostfold Hospital Trust at 3 sites in Norway.
Trial summary
The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fractures, Stress, Metatarsal Fracture
- What is being tested?
- Operative and Walking boot orthosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesNorway
- Study dates
- 10 Apr 2021to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Zone 3 fracture
Who cannot join
- Neuropathy
- Open fractures
- High energy injuries
- Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
- Pressure ulcer(s)
- Lack of consent competence
Show all 11Show fewer
- Fracture radiologically confirmed more than six months ago
- No possibility of follow-up at one of the study centers
- Established pseudarthrosis
- Medical condition that contraindicates surgery
- Non-compliance
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Recruiting
Østfold Hospital Trust
Grålum
Petter Morten Pettersen, MD
- Recruiting
Akershus University Hospital
Lørenskog
Tor Kristian Andresen, MD
- Recruiting
Oslo University Hospital
Oslo
Are Haukåen Stødle, MD, PhD
About this study
Official title: Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.
- Conditions
- Fractures, Stress, Metatarsal Fracture
- Being tested
- Operative, Walking boot orthosis
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperativeProcedure or surgery
Also called Osteosynthesis
Intramedullary screw fixation
Walking boot orthosisOther
Non-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Operative | Active comparator | The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks. Receives: Procedure: Operative; Other: Walking boot orthosis |
| Non-operative | Active comparator | The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated Receives: Other: Walking boot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain free weight bearing
Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".
Measured: 2 years
Secondary outcomes (7)
Palpatory pain
Visual Analog Scale below 3
Measured: 2 years
Radiological healing
Time to radiological callus formation
Measured: 2 years
Work status
Time of sick leave
Measured: 2 years
Refracture
Rate of refractures
Measured: 2 years
Delayed union
Rate of delayed unions
Measured: 2 years
Nonunions
Rate of nonunions
Measured: 2 years
Level of activity
Time to normal activity level is resumed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start10 Apr 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, StressStudies 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
- Prospecitve, randomized trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Marius Molund, PhD, Principal investigator, Ostfold HT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847115
- Sponsor's protocol ID
- 201144
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04847115
- Acronym / sponsor ID
- 201144
- Conditions
- Fractures, Stress, Metatarsal Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 19 Apr 2021 (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 fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospecitve, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Operative | Active comparator | Procedure: Operative, Other: Walking boot orthosisThe patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks. |
| Non-operative | Active comparator | Other: Walking boot orthosisThe patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Zone 3 fracture
Key exclusion criteria (11 listed)
- Neuropathy
- Open fractures
- High energy injuries
- Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
- Pressure ulcer(s)
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 |
|---|---|---|
| OperativeAlso: OsteosynthesisIntramedullary screw fixation | Procedure or surgery | Operative |
| Walking boot orthosisNon-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment. | Other | Non-operative, Operative |
Primary outcome
Pain free weight bearing
Time frame: 2 years
Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".
7 secondary outcomes
Palpatory pain
Time frame: 2 years
Radiological healing
Time frame: 2 years
Work status
Time frame: 2 years
Refracture
Time frame: 2 years
Delayed union
Time frame: 2 years
Nonunions
Time frame: 2 years
Level of activity
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- 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.
Marius Molund, PhD principal investigator
Ostfold HT
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative and Walking boot orthosis in people with Fractures, Stress and Metatarsal Fracture, run by Ostfold Hospital Trust at 3 sites 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Apr 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marius Molund, PhD (0047 90093988, marius.molund@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain free weight bearing (time frame: 2 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 29 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.