Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

NCT03067454 | Completed

• 1 other identifier: FOU 2017-0056
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Fracture

Keywords

early mobilisation; metacarpal fracture; operation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Handfunction rated by the DASH-score

  1 year

• Range of motion in the treated hand/fingerray

  1 year

• Appearance and severity of complications

  1 year

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

  1 year

• The total costs of each treatment

  1 year

Study Arms (2)

conservative group

OTHER

Treatment with early mobilisation

Procedure: Early mobilisation

operative group

OTHER

Treatment with operation

Procedure: Operation

Interventions

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.

conservative group

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.

operative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Falu lasarett, Department of Orthopedics

Falun, Dalarna County, 79182, Sweden

Location

Uppsala University Hospital, Dept. of Handsurgery

Uppsala, Uppsala County, 75185, Sweden

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Nils Hailer, Professor

  Department of Orthopedics, Uppsala University Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 1, 2017
• Study Start: March 1, 2017
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)