Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

Elbow Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04648488
• Other study ID #: 202004709
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: November 2020
• Source: Region Östergötland
• Contact: Teresa Holmgren, PhD
• Phone: 0046733584351
• Email: teresa.holmgren[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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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

Related Conditions & MeSH terms

• Early Mobilization
• Elbow Fracture
• Elbow Stiffnes
• Fracture Dislocation
• Fractures, Bone

Intervention

Other:
• Experimental early mobilisation
early activ assisted exercises treatment
• Aktive comparator standrad treatmnet
standard treatment with a plaster 3 weeks and then active assisted exercises

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Region Östergötland	Jönköping county council, Kalmar County Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford elbow score (OES 0-48 Points)	Evaluating pain, elbowfunction and psychological status	12 month follow up
Secondary	upper extremity activity scale (0-8)	Activity level Before and after injury	12 month follow up
Secondary	Range of motion	elbow range of motion measured with goniometer	12 month follow up
Secondary	Heterotopic ossification	Number of patients with heterotopic ossification verfified by X ray	3 month follow up
Secondary	Re-operation	Number of patients with stiff elbow who need re-operation	in between 3 and 12 month follow up
Secondary	Patient Global impression of change	Patient satisfaction	at three and 12 months