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Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment - a Prospective Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067454
Enrollment
42
Registered
2017-03-01
Start date
2017-03-01
Completion date
2021-05-28
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture

Keywords

early mobilisation, metacarpal fracture, operation

Brief 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. 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.

Interventions

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.

PROCEDUREOperation

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.

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Grip-strength measured by the JAMAR dynamometer1 yearPower of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand

Secondary

MeasureTime frameDescription
Handfunction rated by the DASH-score1 yearDASH-score
Range of motion in the treated hand/fingerray1 yearRange of motion in the treated hand measured in degrees of active motion with a hand held goniometer (operated fingerray)
Appearance and severity of complications1 yearComplications during the different treatments
Time until the patient can return to work, driving and sport1 yearReturn to work, driving and sport
The total costs of each treatment1 yearCosts of each treatment

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026