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Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

NCT ID: NCT04648488

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Early Mobilization Elbow Stiffnes Elbow Fracture

Keywords

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Upper extremity function Elbow stiffnes Early mobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Clinical trail
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental early mobilisation

Intervention Type OTHER

early activ assisted exercises treatment

Standard treatment

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

Group Type ACTIVE_COMPARATOR

Aktive comparator standrad treatmnet

Intervention Type OTHER

standard treatment with a plaster 3 weeks and then active assisted exercises

Interventions

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Experimental early mobilisation

early activ assisted exercises treatment

Intervention Type OTHER

Aktive comparator standrad treatmnet

standard treatment with a plaster 3 weeks and then active assisted exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kalmar County Council

UNKNOWN

Sponsor Role collaborator

Jönköping county council

UNKNOWN

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

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Teresa Holmgren

PhD Registered physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Teresa Holmgren, PhD

Role: CONTACT

Phone: 0046733584351

Email: [email protected]

Hanna Björnsson Hallgren, PhD

Role: CONTACT

Phone: 0046709473276

Email: [email protected]

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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202004709

Identifier Type: -

Identifier Source: org_study_id