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Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

Primary Purpose

Fracture

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early mobilisation
Operation
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring early mobilisation, metacarpal fracture, operation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Falu lasarett, Department of Orthopedics
  • Uppsala University Hospital, Dept. of Handsurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

conservative group

operative group

Arm Description

Treatment with early mobilisation

Treatment with operation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2017
Last Updated
July 9, 2021
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT03067454
Brief Title
Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment
Official Title
Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment - a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
early mobilisation, metacarpal fracture, operation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised controlled trial to compare operation and treatment with early mobilisation for metacarpalfractures
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conservative group
Arm Type
Other
Arm Description
Treatment with early mobilisation
Arm Title
operative group
Arm Type
Other
Arm Description
Treatment with operation
Intervention Type
Procedure
Intervention Name(s)
Early mobilisation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Operation
Intervention Description
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 Outcome Measure Information:
Title
Grip-strength measured by the JAMAR dynamometer
Description
Power of the treated hand measured by the JAMAR dynamometer compared with the none-operated hand
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Handfunction rated by the DASH-score
Description
DASH-score
Time Frame
1 year
Title
Range of motion in the treated hand/fingerray
Description
Range of motion in the treated hand measured in degrees of active motion with a hand held goniometer (operated fingerray)
Time Frame
1 year
Title
Appearance and severity of complications
Description
Complications during the different treatments
Time Frame
1 year
Title
Time until the patient can return to work, driving and sport
Description
Return to work, driving and sport
Time Frame
1 year
Title
The total costs of each treatment
Description
Costs of each treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Hailer, Professor
Organizational Affiliation
Department of Orthopedics, Uppsala University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Muder, MD, Dr. med.
Organizational Affiliation
Department of Orthopedics, Falu lasarett
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grey Giddins, M.B.B.Ch. F.R.C.S. (Orth)
Organizational Affiliation
Royal United Hospitals Bath NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Falu lasarett, Department of Orthopedics
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Uppsala University Hospital, Dept. of Handsurgery
City
Uppsala
State/Province
Uppsala Län
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

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