Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

November 23, 2020 updated by: Teresa Holmgren, Region Östergötland

Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation - a Randomised Clinical Trial

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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: 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early mobilisation
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.
early activ assisted exercises treatment
ACTIVE_COMPARATOR: Standard treatment
Patients will have a plaster 3 weeks after surgery and after that start with exercise treatment.
standard treatment with a plaster 3 weeks and then active assisted exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford elbow score (OES 0-48 Points)
Time Frame: 12 month follow up
Evaluating pain, elbowfunction and psychological status
12 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
upper extremity activity scale (0-8)
Time Frame: 12 month follow up
Activity level Before and after injury
12 month follow up
Range of motion
Time Frame: 12 month follow up
elbow range of motion measured with goniometer
12 month follow up
Heterotopic ossification
Time Frame: 3 month follow up
Number of patients with heterotopic ossification verfified by X ray
3 month follow up
Re-operation
Time Frame: in between 3 and 12 month follow up
Number of patients with stiff elbow who need re-operation
in between 3 and 12 month follow up
Patient Global impression of change
Time Frame: at three and 12 months
Patient satisfaction
at three and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (ACTUAL)

December 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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