Outpatient Versus Inpatient Surgery for Ankle Fractures

NCT ID: NCT05389436

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2025-03-20

Brief Summary

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

Detailed 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.

Conditions

Ankle Fractures; Orthopedic Procedures; Surgical Procedures; Inpatient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Ambulatory care

Intervention Type: PROCEDURE

The surgery is performed in ambulatory setting

Standard

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

Group Type: ACTIVE_COMPARATOR

Inpatient care

Intervention Type: PROCEDURE

The surgery is performed during inpatient care

Interventions

Ambulatory care

The surgery is performed in ambulatory setting

Intervention Type: PROCEDURE

Inpatient care

The surgery is performed during inpatient care

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christian Grundtvig Refstrup Rasmussen

OTHER

Sponsor Role: lead

Responsible Party

Christian Grundtvig Refstrup Rasmussen

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian GR Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedic Surgery

Locations

Aalborg Universitetshospital

Aalborg, , Denmark

Countries

Denmark

References

Rasmussen CG, Larsen P, Pedersen C, Elsoe R. Outpatient versus inpatient surgery for ankle fractures - a protocol for a randomised controlled trial. Dan Med J. 2025 Jun 26;72(7):A10240746. doi: 10.61409/A10240746.

Reference Type: DERIVED

PMID: 40600684 (View on PubMed)

Other Identifiers

N-20220012

Identifier Type: -

Identifier Source: org_study_id