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NCT Number: NCT03067454

Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

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.

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falu lasarett, Department of Orthopedics, Falun, Dalarna County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early mobilisation

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.

Operation

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.

Primary outcomes

  1. Grip-strength measured by the JAMAR dynamometer

    Time frame: 1 year

    Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand

Secondary outcomes

  1. Handfunction rated by the DASH-score

    Time frame: 1 year

    DASH-score

  2. Range of motion in the treated hand/fingerray

    Time frame: 1 year

    Range of motion in the treated hand measured in degrees of active motion with a hand held goniometer (operated fingerray)

  3. Appearance and severity of complications

    Time frame: 1 year

    Complications during the different treatments

  4. Time until the patient can return to work, driving and sport

    Time frame: 1 year

    Return to work, driving and sport

  5. The total costs of each treatment

    Time frame: 1 year

    Costs of each treatment

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2017
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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