Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

NCT ID: NCT03067454

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-05-28

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.

Conditions

Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conservative group

Treatment with early mobilisation

Group Type: OTHER

Early mobilisation

Intervention Type: PROCEDURE

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.

operative group

Treatment with operation

Group Type: OTHER

Operation

Intervention Type: PROCEDURE

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.

Interventions

Early mobilisation

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.

Intervention Type: PROCEDURE

Operation

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nils Hailer, Professor

Role: STUDY_DIRECTOR

Department of Orthopedics, Uppsala University Hospital

Daniel Muder, MD, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Falu lasarett

Grey Giddins, M.B.B.Ch. F.R.C.S. (Orth)

Role: PRINCIPAL_INVESTIGATOR

Royal United Hospitals Bath NHS Foundation Trust

Locations

Falu lasarett, Department of Orthopedics

Falun, Dalarna County, Sweden

Uppsala University Hospital, Dept. of Handsurgery

Uppsala, Uppsala County, Sweden

Countries

Sweden

Other Identifiers

FOU 2017-0056

Identifier Type: -

Identifier Source: org_study_id