Clinical trial NCT03067454: Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment
Official title: Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Keywords: early mobilisation
metacarpal fracture
operation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grip-strength measured by the JAMAR dynamometer
timeFrame: 1 year
Secondary outcomes:
measure: Handfunction rated by the DASH-score
timeFrame: 1 year
measure: Range of motion in the treated hand/fingerray
timeFrame: 1 year
measure: Appearance and severity of complications
timeFrame: 1 year
measure: Time until the patient can return to work, driving and sport
timeFrame: 1 year
measure: The total costs of each treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu lasarett, Department of Orthopedics
state: Dalarna
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Dept. of Handsurgery
state: Uppsala Län
Study officials:
affiliation: Department of Orthopedics, Uppsala University Hospital
name: Nils Hailer, Professor
role: STUDY_DIRECTOR
affiliation: Department of Orthopedics, Falu lasarett
name: Daniel Muder, MD, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal United Hospitals Bath NHS Foundation Trust
name: Grey Giddins, M.B.B.Ch. F.R.C.S. (Orth)
role: PRINCIPAL_INVESTIGATOR
References: