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Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

Primary Purpose

Early Mobilization, Elbow Stiffnes, Elbow Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental early mobilisation
Aktive comparator standrad treatmnet
Sponsored by
Region Östergötland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Mobilization focused on measuring Upper extremity function, Elbow stiffnes, Early mobilization

Eligibility Criteria

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

Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on.

-

Exclusion Criteria:

  • ongoing cancer and earlier radiation therapy in the study arm
  • neurological disease
  • cervcialgia or disc herniation in the neck
  • associated nerv or blodvessel injury
  • dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early mobilisation

    Standard treatment

    Arm Description

    Patients will start unloaded exercise treatment 3 days after surgery. They will remove the plaster 5 times every day to perform range of motion exercises.

    Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.

    Outcomes

    Primary Outcome Measures

    Oxford elbow score (OES 0-48 Points)
    Evaluating pain, elbowfunction and psychological status

    Secondary Outcome Measures

    upper extremity activity scale (0-8)
    Activity level Before and after injury
    Range of motion
    elbow range of motion measured with goniometer
    Heterotopic ossification
    Number of patients with heterotopic ossification verfified by X ray
    Re-operation
    Number of patients with stiff elbow who need re-operation
    Patient Global impression of change
    Patient satisfaction

    Full Information

    First Posted
    October 26, 2020
    Last Updated
    November 23, 2020
    Sponsor
    Region Östergötland
    Collaborators
    Kalmar County Council, Jönköping county council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04648488
    Brief Title
    Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation
    Official Title
    Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Region Östergötland
    Collaborators
    Kalmar County Council, Jönköping county council

    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
    The purpose with the study is to evalute if early mobilsation after surgery in patients vid elbow frakture-dislocation may lead to better armfunction and reduce common complications as stiffnes in the elbow. After surgery patients will be randomised to either early mobilisation (exercise treatment 3 Days after surgery) or ordinary treatment (plaster and exercise treatment 3 weeks after surgery).
    Detailed Description
    In patients with elbow fracture in combinations with dislocation, surgery is often indicated. After surgery the ordinary standard praxis treatment is immobilisation in a plaster for 3 weeks. One common complication is "stiff elbow". Stiffness in the elbow may be due to "heterotopic ossification" which is the abnormal growth of bone in the non-skeletal tissues including muscles or tendons. There is a prospective study that have reported positive results with early mobilisation starting two days after surgery in these patients. However, randomised clinical trials are missing. Therefore our aim was to investigate if early mobilisation may increase elbow function (increased range of motion and decreased pain) and also reduce comlications as stiff elbow compared to ordinary treatment in these patients. All patients operated with elbow fracture-dislocation at the University hospital in Linköping were asked if the wanted to participate in the study. They had thourough written and oral information about the study. If they agree to participate written informed consent was collected. After surgery patients were randomised to either early mobilisation or to ordinary treatment (standard praxis). At baseline before surgery or directly after patients filled in some background vatiables such as gender, age social status medical treatment etc They also filled in some self-adminstrated outcome measure in purpuse to evalute upper extremity function and activity and health related quality of Life. Follow ups with X ray and upper extremity function and activity were at 3 weeks 3 and 12 months with an independent observer. In beteween these follow ups patient followed the treatment regime (ordinary or early exrecise treatment) and had support from a physiotherapist.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early Mobilization, Elbow Stiffnes, Elbow Fracture
    Keywords
    Upper extremity function, Elbow stiffnes, Early mobilization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised Clinical trail
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early mobilisation
    Arm Type
    Experimental
    Arm Description
    Patients will start unloaded exercise treatment 3 days after surgery. They will remove the plaster 5 times every day to perform range of motion exercises.
    Arm Title
    Standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental early mobilisation
    Intervention Description
    early activ assisted exercises treatment
    Intervention Type
    Other
    Intervention Name(s)
    Aktive comparator standrad treatmnet
    Intervention Description
    standard treatment with a plaster 3 weeks and then active assisted exercises
    Primary Outcome Measure Information:
    Title
    Oxford elbow score (OES 0-48 Points)
    Description
    Evaluating pain, elbowfunction and psychological status
    Time Frame
    12 month follow up
    Secondary Outcome Measure Information:
    Title
    upper extremity activity scale (0-8)
    Description
    Activity level Before and after injury
    Time Frame
    12 month follow up
    Title
    Range of motion
    Description
    elbow range of motion measured with goniometer
    Time Frame
    12 month follow up
    Title
    Heterotopic ossification
    Description
    Number of patients with heterotopic ossification verfified by X ray
    Time Frame
    3 month follow up
    Title
    Re-operation
    Description
    Number of patients with stiff elbow who need re-operation
    Time Frame
    in between 3 and 12 month follow up
    Title
    Patient Global impression of change
    Description
    Patient satisfaction
    Time Frame
    at three and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on. - Exclusion Criteria: ongoing cancer and earlier radiation therapy in the study arm neurological disease cervcialgia or disc herniation in the neck associated nerv or blodvessel injury dementia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Teresa Holmgren, PhD
    Phone
    0046733584351
    Email
    teresa.holmgren@regionostergotland.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanna Björnsson Hallgren, PhD
    Phone
    0046709473276
    Email
    hanna.bjornssonhallgren@regionostergotland.se

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

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