FractureNCT03067454
Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment
A study testing Early mobilisation and Operation in people with Fracture, run by Uppsala University at 2 sites in Sweden.
Trial summary
Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- What is being tested?
- Early mobilisation and Operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Mar 2017to 28 May 2021
- 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
- single spiral fractures of metacarpal bone II-V
- fracture line at least twice the length of the diameter of the bone at the level of the fracture
- at least 1-2mm displacement of the fracture and/or malrotation
- normal hand function before the injury
- fracture less than 10 days old
Who cannot join
- multiple metacarpal fractures
- open fractures
- incompliance or dementia
- fracture line not twice the length of the diameter of the bone at the level of the fracture
- abnormal hand function before the injury
- fracture more than 10 days old
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Falu lasarett, Department of Orthopedics
Falun, Dalarna County, 79182
Uppsala University Hospital, Dept. of Handsurgery
Uppsala, Uppsala County, 75185
About this study
Official title: Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment - a Prospective Randomized Trial
Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws. Even if this is an standard procedure both mild and severe complications have been reported. New studies have shown that even displaced fractures can be treated with early mobilization. In those cases the fractures may heal with some shortening but very good function. An advantage of early mobilization is that the patient avoids the risk of an operation and the costs for the treatment are decreased markedly. The study is designed to answer the question if early mobilization is not inferior to operative treatment but with lower costs and without any operation related risks.
Read the detailed description
The study is designed as an prospective, randomised controlled trial. The patients are divided into two groups (operative and conservative treatment with early mobilisation). The operative group is treated with internal fixation and 2 weeks in a cast. The conservative group is instructed to do a fist to correct any malrotation and to rehabilitate quickly. By this procedure shortening oft he metacarpalfractures is limited by the function of the deep transverse metacarpal ligament connecting the distal parts of the metacarpalbones II-V. Furthermore the participants in the conservative group are allowed to use their hands without any restrictions. A physiotherapist controls that early mobilisation is carried out.
The participant will be seen for a follow-up at 1, 6 and 12 weeks and 1 year. Radiographs will be performed at 1v and 6v. The finger ranges of motion and pain will be evaluated with every follow-up, DASH score, range of motion, pain and grip-strength will be measured after 12v and 1 year. The investigators will measure return to driving, work and sport.
Complications will be registered continuously for all patients. The overall satisfaction of the patients and the costs for both treatments will be documented as well.
The study population is planned to be 21 patients in each group.
- Conditions
- Fracture
- Being tested
- Early mobilisation, Operation
- Keywords
- early mobilisation, metacarpal fracture, operation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilisationProcedure or surgery
Conservative treatment with early mobilisation
The patient is instructed to do a fist and is not allowed to leave the clinic before. Active mobilisation under control (doctor or physiotherapist) is performed until healing of the fracture is documented.
OperationProcedure or surgery
Operation of the fracture. Usually open reduction and internal fixation with plates and screws or just screws within 2 weeks of injury. Immobilisation in a cast for two weeks followed by physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| conservative group | Other | Treatment with early mobilisation Receives: Procedure: Early mobilisation |
| operative group | Other | Treatment with operation Receives: Procedure: Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip-strength measured by the JAMAR dynamometer
Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand
Measured: 1 year
Secondary outcomes (5)
Handfunction rated by the DASH-score
DASH-score
Measured: 1 year
Range of motion in the treated hand/fingerray
Range of motion in the treated hand measured in degrees of active motion with a hand held goniometer (operated fingerray)
Measured: 1 year
Appearance and severity of complications
Complications during the different treatments
Measured: 1 year
Time until the patient can return to work, driving and sport
Return to work, driving and sport
Measured: 1 year
The total costs of each treatment
Costs of each treatment
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 Mar 2017
- Study start1 Mar 2017
- Primary completion28 May 2021
- Study completion28 May 2021
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 FractureStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Model description
- Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nils Hailer, Professor, Study director, Uppsala University HospitalDaniel Muder, MD, Dr. med., Principal investigator, Department of Orthopedics, Falu lasarettGrey Giddins, M.B.B.Ch. F.R.C.S. (Orth), Principal investigator, Royal United Hospitals Bath NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067454
- Sponsor's protocol ID
- FOU 2017-0056
- Status last verified
- Jul 2021
- First submitted
- 21 Feb 2017
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stalberg Ostwald C, Peyronson F, Hailer NP, Muder D. Radiographic assessment of metacarpal shortening after nonoperative and operative treatment of spiral and oblique metacarpal shaft fractures. Injury. 2026 Oct 4;57(11):113757. doi: 10.1016/j.injury.2026.113757. Online ahead of print.
PubMed 42849244
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment - a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03067454
- Acronym / sponsor ID
- FOU 2017-0056
- Conditions
- Fracture
- Keywords
- early mobilisation, metacarpal fracture, operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 1 Mar 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.
Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws. Even if this is an standard procedure both mild and severe complications have been reported. New studies have shown that even displaced fractures can be treated with early mobilization. In those cases the fractures may heal with some shortening but very good function. An advantage of early mobilization is that the patient avoids the risk of an operation and the costs for the treatment are decreased markedly. The study is designed to answer the question if early mobilization is not inferior to operative treatment but with lower costs and without any operation related risks.
Detailed description
The study is designed as an prospective, randomised controlled trial. The patients are divided into two groups (operative and conservative treatment with early mobilisation). The operative group is treated with internal fixation and 2 weeks in a cast. The conservative group is instructed to do a fist to correct any malrotation and to rehabilitate quickly. By this procedure shortening oft he metacarpalfractures is limited by the function of the deep transverse metacarpal ligament connecting the distal parts of the metacarpalbones II-V. Furthermore the participants in the conservative group are allowed to use their hands without any restrictions. A physiotherapist controls that early mobilisation is carried out.
The participant will be seen for a follow-up at 1, 6 and 12 weeks and 1 year. Radiographs will be performed at 1v and 6v. The finger ranges of motion and pain will be evaluated with every follow-up, DASH score, range of motion, pain and grip-strength will be measured after 12v and 1 year. The investigators will measure return to driving, work and sport.
Complications will be registered continuously for all patients. The overall satisfaction of the patients and the costs for both treatments will be documented as well.
The study population is planned to be 21 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures
| Arm | Type | Receives |
|---|---|---|
| conservative group | Other | Procedure: Early mobilisationTreatment with early mobilisation |
| operative group | Other | Procedure: OperationTreatment with operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- single spiral fractures of metacarpal bone II-V
- fracture line at least twice the length of the diameter of the bone at the level of the fracture
- at least 1-2mm displacement of the fracture and/or malrotation
- normal hand function before the injury
- fracture less than 10 days old
Key exclusion criteria (6 listed)
- multiple metacarpal fractures
- open fractures
- incompliance or dementia
- fracture line not twice the length of the diameter of the bone at the level of the fracture
- abnormal hand function before the injury
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 |
|---|---|---|
| Early mobilisationConservative treatment with early mobilisation The patient is instructed to do a fist and is not allowed to leave the clinic before. Active mobilisation under control (doctor or physiotherapist) is performed until healing of the fracture is documented. | Procedure or surgery | conservative group |
| OperationOperation of the fracture. Usually open reduction and internal fixation with plates and screws or just screws within 2 weeks of injury. Immobilisation in a cast for two weeks followed by physiotherapy. | Procedure or surgery | operative group |
Primary outcome
Grip-strength measured by the JAMAR dynamometer
Time frame: 1 year
Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand
5 secondary outcomes
Handfunction rated by the DASH-score
Time frame: 1 year
Range of motion in the treated hand/fingerray
Time frame: 1 year
Appearance and severity of complications
Time frame: 1 year
Time until the patient can return to work, driving and sport
Time frame: 1 year
The total costs of each treatment
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 16 Jul 2021.
- Derived from this study: PubMed 42849244Stalberg Ostwald C, Peyronson F, Hailer NP, Muder D. Radiographic assessment of metacarpal shortening after nonoperative and operative treatment of spiral and oblique metacarpal shaft fractures. Injury. 2026 Oct 4;57(11):113757. doi: 10.1016/j.injury.2026.113757. Online ahead of print.
- 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.
Nils Hailer, Professor study director
Uppsala University Hospital
Daniel Muder, MD, Dr. med. principal investigator
Department of Orthopedics, Falu lasarett
Grey Giddins, M.B.B.Ch. F.R.C.S. (Orth) principal investigator
Royal United Hospitals Bath NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilisation and Operation in people with Fracture, run by Uppsala University at 2 sites in Sweden.
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 5 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Grip-strength measured by the JAMAR dynamometer (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 NCT03067454, 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 16 Jul 2021.