Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study. (TOP-ANK)

January 13, 2026 updated by: Nantes University Hospital

Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study

Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • France
      • Nantes, France, France, 44000
        • Dr Gadbed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years of age
  • Patient with an ankle joint injury with surgical indication
  • Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture
  • Patient affiliated to a social security system
  • Patient having signed an informed consent

Exclusion Criteria:

  • Patient with chronic respiratory insufficiency
  • Patient with sleep apnea with equipment
  • Patient under long term oxygen therapy
  • Patient with a bilateral ankle fracture
  • Polytrauma patients
  • Pregnant or breastfeeding women or those refusing effective contraception
  • Patient deprived of liberty or under legal protection (guardianship or curatorship)
  • Patient unable to follow the protocol, as judged by the investigator
  • Patient refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (A)
Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization
Drug: Oxygen
administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.
Other Names:
  • O2
Other: Control group (B)
No oxygen therapy during hospitalization
Other: no oxygen therapy
No oxygen therapy during hospitalization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cutaneous and infectious complications
Time Frame: 6 months
Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Observer Scar Assessment Scale (OSAS questionnaire)
Time Frame: 3 weeks after surgery
The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points
3 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
Time Frame: 6 weeks after surgery
The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points
6 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
Time Frame: 12 weeks after surgery
The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points
12 weeks after surgery
Revision surgery
Time Frame: 6 months after surgery
6 months after surgery
Pseudoarthrosis Complication
Time Frame: 24 weeks after surgery
Presence of delayed healing on radiograph at S24
24 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: preoperatively
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
preoperatively
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 24 hours after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
24 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 48 hours after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
48 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 3 weeks after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
3 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 6 weeks after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
6 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 12 weeks after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
12 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time Frame: 24 weeks after surgery
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
24 weeks after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
Time Frame: before the initiation of oxygen therapy preoperatively
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
before the initiation of oxygen therapy preoperatively
Transcutaneous oxygen pressure measurements (TcPO2)
Time Frame: 48hours after surgery
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
48hours after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
Time Frame: 3 weeks after surgery
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: pre-operatively
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
pre-operatively
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: 48 hours after surgery
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
48 hours after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: 3 weeks after surgery
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: 6 weeks after surgery
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
6 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: 12 weeks after surgery
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
12 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time Frame: 24 weeks after surgery
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
24 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radiometer Medical ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC21_0129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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