Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

Not Applicable

Completed

• Conditions: Fracture
• Interventions: Procedure: Early mobilisation; Procedure: Operation

• Registration Number: NCT03067454
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-24
• Study Start: 2017-03-01
• Study First Posted: 2017-03-01
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative group	Early mobilisation	Treatment with early mobilisation
operative group	Operation	Treatment with operation

Primary Outcome Measures

Name	Time	Method
Grip-strength measured by the JAMAR dynamometer	1 year	Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand

Secondary Outcome Measures

Name	Time	Method
Handfunction rated by the DASH-score	1 year	DASH-score
Time until the patient can return to work, driving and sport	1 year	Return to work, driving and sport
The total costs of each treatment	1 year	Costs of each treatment
Range of motion in the treated hand/fingerray	1 year	Range of motion in the treated hand measured in degrees of active motion with a hand held goniometer (operated fingerray)
Appearance and severity of complications	1 year	Complications during the different treatments

Trial Locations

Locations (2)

Falu lasarett, Department of Orthopedics; 🇸🇪 Falun, Dalarna, Sweden

Uppsala University Hospital, Dept. of Handsurgery; 🇸🇪 Uppsala, Uppsala Län, Sweden