Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067454
• Other study ID #: FOU 2017-0056
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 28, 2021

Study information

• Verified date: July 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Falu lasarett, Department of Orthopedics	Falun	Dalarna
Sweden	Uppsala University Hospital, Dept. of Handsurgery	Uppsala	Uppsala Län

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip-strength measured by the JAMAR dynamometer	Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand	1 year
Secondary	Handfunction rated by the DASH-score	DASH-score	1 year
Secondary	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)	1 year
Secondary	Appearance and severity of complications	Complications during the different treatments	1 year
Secondary	Time until the patient can return to work, driving and sport	Return to work, driving and sport	1 year
Secondary	The total costs of each treatment	Costs of each treatment	1 year