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Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04648488
Enrollment
60
Registered
2020-12-01
Start date
2021-01-01
Completion date
2023-01-01
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Mobilization, Elbow Fracture, Elbow Stiffnes

Keywords

Upper extremity function, Elbow stiffnes, Early mobilization

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.

Interventions

OTHERExperimental early mobilisation

early activ assisted exercises treatment

OTHERAktive comparator standrad treatmnet

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

Sponsors

Kalmar County Council
CollaboratorUNKNOWN
Jönköping county council
CollaboratorUNKNOWN
Region Östergötland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomised Clinical trail

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxford elbow score (OES 0-48 Points)12 month follow upEvaluating pain, elbowfunction and psychological status

Secondary

MeasureTime frameDescription
Patient Global impression of changeat three and 12 monthsPatient satisfaction
Re-operationin between 3 and 12 month follow upNumber of patients with stiff elbow who need re-operation
upper extremity activity scale (0-8)12 month follow upActivity level Before and after injury
Range of motion12 month follow upelbow range of motion measured with goniometer
Heterotopic ossification3 month follow upNumber of patients with heterotopic ossification verfified by X ray

Contacts

Primary ContactTeresa Holmgren, PhD
teresa.holmgren@regionostergotland.se0046733584351
Backup ContactHanna Björnsson Hallgren, PhD
hanna.bjornssonhallgren@regionostergotland.se0046709473276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026