Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture
• Intervention / Treatment: Procedure: Early mobilisation; Procedure: Operation

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Dalarna
    • Falun, Dalarna, Sweden, 79182
      • Falu lasarett, Department of Orthopedics
  • Uppsala Län
    • Uppsala, Uppsala Län, Sweden, 75185
      • Uppsala University Hospital, Dept. of Handsurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conservative group; Treatment with early mobilisation	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.
Other: operative group; Treatment with operation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handfunction rated by the DASH-score	DASH-score	1 year
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
Appearance and severity of complications	Complications during the different treatments	1 year
Time until the patient can return to work, driving and sport	Return to work, driving and sport	1 year
The total costs of each treatment	Costs of each treatment	1 year

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Director: Nils Hailer, Professor, Department of Orthopedics, Uppsala University Hospital; Principal Investigator: Daniel Muder, MD, Dr. med., Department of Orthopedics, Falu lasarett; Principal Investigator: Grey Giddins, M.B.B.Ch. F.R.C.S. (Orth), Royal United Hospitals Bath NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: operation; metacarpal fracture; early mobilisation
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: FOU 2017-0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No