Outpatient Versus Inpatient Surgery for Ankle Fractures

NCT05389436 | Completed DMC

• 1 other identifier: N-20220012
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Orthopedic Procedures; Surgical Procedures; Inpatient

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Outcomes Score

  The FAOS is a patient-reported structure-specific questionnaire. Consisting of 5 subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec), and foot- and ankle-related quality of life (QOL). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.

  12 weeks

Secondary Outcomes (8)

• Patient satisfaction

  2, 6 and 12 weeks

• EQ-5D-5L questionnaire (5-level version)

  2, 6 and 12 weeks

• Tegner activity scale

  12 weeks

• Adverse events

  2 days, 2, 6 and 12 weeks

• Time to return to work

  2, 6 and 12 weeks

Study Arms (2)

Experimental

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

Procedure: Ambulatory care

Standard

ACTIVE COMPARATOR

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

Procedure: Inpatient care

Interventions

Ambulatory care PROCEDURE

The surgery is performed in ambulatory setting

Experimental

Inpatient care PROCEDURE

The surgery is performed during inpatient care

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Grundtvig Refstrup Rasmussen: lead

Study Sites (1)

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40600684 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Interventions

Ambulatory Care; Hospitalization

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christian GR Rasmussen, MD

  Department of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of this study the patient, surgeon and care providers can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Model Details: This study is a single center, prospective, assessor-blinded, randomized independent clinical trial

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: May 23, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)