Outpatient Versus Inpatient Surgery for Ankle Fractures (OVISAF)

Christian Grundtvig Refstrup Rasmussen

Status: Completed

Conditions: Surgical Procedures; Orthopedic Procedures; Inpatient; Ankle Fractures

Treatments: Procedure: Ambulatory care; Procedure: Inpatient care

Study type: Interventional

Funder types: Other

Identifiers

NCT05389436

N-20220012

Details and patient eligibility

About

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Full description

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Primary outcome: The primary objective of this study is to compare the 12-weeks patient reported Foot and Ankle Outcome Score (FOAS).

Secondary outcomes: Multiple other analysis are planned, but being secondary, they are hypothesis generating. They will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ankle fracture indicating surgical treatment.
• Fracture stable in lower leg cast.
• Patient 18 years or older.
• Patient is able to ambulate with walking aid, and perform ADL at home.

Exclusion criteria

• Impaired physical, mental or social capacity incapable of participating in study.
• Incapable of reading or understanding Danish.
• Patient does not wich to participate.
• Concurrent major fracture to lower extremity (ipsi- and/or contralateral)
• Patholocigal fracture
• ASA score 3 or higher.
• Pregnancy.
• Open fracture.
• Infectious disease requiring isolation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Experimental

Experimental group

Description:

The patient is discharged from the ER following X-ray, casting, charts. The patient is contacted when surgery is scheduled, and this is performed in a ambulatory setting

Treatment:

Procedure: Ambulatory care

Standard

Active Comparator group

Description:

The patient is admitted from the ER, surgery is performed when possible in regards to surgical capacity and swelling. Discharged when mobilised with cast.

Treatment:

Procedure: Inpatient care