Outpatient Versus Inpatient Surgery for Ankle Fractures

Ankle Fractures Clinical Trial

— OVISAF  

Official title:

Comparison Between Outpatient and Inpatient Surgically Treated Ankle Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389436
• Other study ID #: N-20220012
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: May 2026

Study information

• Verified date: August 2022
• Source: Aalborg University Hospital
• Contact: Christian GR Rasmussen, MD
• Phone: 97660000
• Email: christian.rasmussen[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: May 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Inpatient
• Orthopedic Procedures
• Surgical Procedures

Intervention

Procedure:
• Ambulatory care
The surgery is performed in ambulatory setting
• Inpatient care
The surgery is performed during inpatient care

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Christian Grundtvig Refstrup Rasmussen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction	Patient reported satisfaction. The patient is asked: "Given your experience with the treatment, how likely is it that you would choose it again?" and the possible answers are preplanned, using a 5 point Lickert scale: Very likely, likely, either/or, unlikely, very unlikely.; "Given your experience with the treatment, how likely is it, that you would recommend it to a relative or friend?" and the possible answers are preplanned, using a 5 point Lickert scale: Very likely, likely, either/or, unlikely, very unlikely.	2, 6 and 12 weeks
Secondary	EQ-5D-5L questionnaire (5-level version)	General health will be assessed using EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death.	2, 6 and 12 weeks
Secondary	Tegner activity scale	The Tegner activity scale is a 1-item instrument that assesses activity levels for sports (competitive or recreational) and occupational activities (light or heavy labor). It evaluates the patient's level of work and sports activity on an 11-level scale, with higher scores representing higher levels of physical activity.	12 weeks
Secondary	Adverse events	Adverse events, defined as any negative or unwanted reactions to the two groups will be recorded. Based on previous reports we will focus on: infection, DVT and re-operation. Patients are continuously requested to report any suspicion of a potential AE. Patients will be asked about potential AEs. Furthermore, medical records will be checked at the primary endpoint (12 weeks) for all AEs occurring from inclusion until the 12 week follow-up. An AE is defined as any undesirable experience during follow-up leading to contact with the healthcare system (general practitioner or hospital). If an AE result in hospitalization, prolonged inpatient hospital care, result in re-surgery, or if an AE is life-threatening, result in death, permanent disability or damage, they will be categorized as serious adverse events (SAEs).	2 days, 2, 6 and 12 weeks
Secondary	Time to return to work	The time from surgery to end of sick leave measured in days.	2, 6 and 12 weeks
Secondary	Bone union	Bone union, will be evaluated on standard AP and side X-rays of the fractured ankle. The evaluation of bone union will be defined as: i) visible callus formation, diminished no visible fracture line and no pain from the fracture site at weight-bearing and at clinical examination.	6 and 12 weeks
Secondary	Pain intensity measured on a 10 cm VAS scale	Development in pain will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.	2 days, 2, 6 and 12 weeks
Secondary	Ankle range of motion	Ankle range of motion. With the patient supine on an examination table the full range of passive motion in both ankle joints will be measured using a standard goniometer.	6 and 12 weeks