Ankle FracturesPhase 3TOP-ANKNCT05185115
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
A Phase 3 study testing Oxygen and no oxygen therapy in people with Ankle Fractures, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Oxygen and no oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2022to 1 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Ankle Fractures
- Being tested
- Oxygen, no oxygen therapy
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called O2
administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.
no oxygen therapyOther
No oxygen therapy during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (A) | Experimental | Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization Receives: Drug: Oxygen |
| Control group (B) | Other | No oxygen therapy during hospitalization Receives: Other: no oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous and infectious complications
Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion
Measured: 6 months
Secondary outcomes (21)
Observer Scar Assessment Scale (OSAS questionnaire)
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
Measured: 3 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
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
Measured: 6 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
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
Measured: 12 weeks after surgery
Revision surgery
Measured: 6 months after surgery
Pseudoarthrosis Complication
Presence of delayed healing on radiograph at S24
Measured: 24 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: preoperatively
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 24 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 48 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 3 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 6 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 12 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Measured: 24 weeks after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Measured: before the initiation of oxygen therapy preoperatively
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Measured: 48hours after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Measured: 3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: pre-operatively
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: 48 hours after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: 3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: 6 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: 12 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Measured: 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start9 Apr 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radiometer Medical ApS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185115
- Sponsor's protocol ID
- RC21_0129
- Acronym
- TOP-ANK
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2021
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05185115
- Acronym / sponsor ID
- TOP-ANK / RC21_0129
- Conditions
- Ankle Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Radiometer Medical ApS
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (A) | Experimental | Drug: OxygenPatients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization |
| Control group (B) | Other | Other: no oxygen therapyNo oxygen therapy during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenAlso: O2administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization. | Drug | Intervention group (A) |
| no oxygen therapyNo oxygen therapy during hospitalization | Other | Control group (B) |
Primary outcome
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
21 secondary outcomes
Observer Scar Assessment Scale (OSAS questionnaire)
Time frame: 3 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
Time frame: 6 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)
Time frame: 12 weeks after surgery
Revision surgery
Time frame: 6 months after surgery
Pseudoarthrosis Complication
Time frame: 24 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: preoperatively
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 24 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 48 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 3 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 6 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 12 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain
Time frame: 24 weeks after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
Time frame: before the initiation of oxygen therapy preoperatively
Transcutaneous oxygen pressure measurements (TcPO2)
Time frame: 48hours after surgery
Transcutaneous oxygen pressure measurements (TcPO2)
Time frame: 3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: pre-operatively
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: 48 hours after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: 3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: 6 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: 12 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Time frame: 24 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen and no oxygen therapy in people with Ankle Fractures, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous and infectious complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.