Lateral Malleolus FractureNCT04429217
A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
A study testing immediate post-operative complete weight-bearing after surgery and delayed weight-bearing for 6 weeks after surgery in people with Lateral Malleolus Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lateral Malleolus Fracture
- What is being tested?
- immediate post-operative complete weight-bearing after surgery and delayed weight-bearing for 6 weeks after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Apr 2020to 2 Feb 2028
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults
- Age ranging from 18 to 70 years, included
- Signed Informed Consent
- Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture
- Willingness and ability to participate in the trial
Who cannot join
- Weber C fracture pattern
- Bilateral fractures or fractures in other locations
- Maissoneauve associated lesion
- Body Mass Index < 18.5 and ≥ 30
- Metabolic diseases influencing fracture healing processes
- Medical comorbidities precluding operative intervention
Show all 10Show fewer
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
- Inability or contraindications to undergo the investigated intervention
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ente Ospedaliero Cantonale
Lugano, 6900
Enrique Adrian Testa, MD, +41 (0)91 811 69 31, enriqueadrian.testa@eoc.ch
Christian Candrian, MD, Prof, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
About this study
Official title: Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing.
The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.
Read the detailed description
The study population corresponds to the patients who may benefit from a post-operative rehabilitation protocol with immediate weight-bearing. Eligible lateral malleolar fractures are limited to Weber A and Weber B fractures, since they have a higher stability, after open reduction and internal fixation, compared to Weber C and Maisonneuve fractures. This higher stability gives the possibility to evaluate the benefit of the immediate weight-bearing protocol without safety concerns.
A power analysis was performed to estimate the required sample size to detect a significant difference in the OMAS score at 6 weeks between groups: the number of patients needed is 42 patients per group (84 patients overall) but, considering the risk of drop-outs, the investigators plan to enroll 20% more patients for a total of 100 patients.
The surgical operation will be carried out following the AO Foundation general and specific rules concerning the surgical treatment of malleolar fractures . In particular,an anatomical open reduction and internal fixation with one or two compression screws sustained by a neutralization third-tubular plate for simple fractures or a bridging third-tubular locking compression plate for multi-fragmentary fractures will be performed.
Postoperatively, patients who still meet the eligibility criteria will be randomized in 2 groups: immediate post-operative complete weight-bearing and complete weight-bearing delayed for 6 weeks.Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids (patients will wear an ankle brace, this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement). Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery (also patients of the control group will wear the ankle brace).
Subsequent follow-up visits are scheduled at 2, 6, 12 and 24 weeks after surgery. Patients with a fracture non-union radiologically confirmed at week 24 will be followed up until 48 weeks after surgery. Clinical assessments will be performed using subjective, objective and radiological evaluations. Safety will be monitored throughout the study.
Overall study duration will be 2 years and 6 months (2 years to reach the expected sample size and 6 months to complete the follow-up):
- Conditions
- Lateral Malleolus Fracture
- Being tested
- immediate post-operative complete weight-bearing after surgery, delayed weight-bearing for 6 weeks after surgery
- Keywords
- Ankle, surgical treatment, malleolar fractures
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate post-operative complete weight-bearing after surgeryOther
Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids.
During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.
delayed weight-bearing for 6 weeks after surgeryOther
Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery.
During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | experimental post-operative rehabilitation intervention consisting in immediate weight-bearing Receives: Other: immediate post-operative complete weight-bearing after surgery |
| Arm-B | Active comparator | control post-operative rehabilitation intervention consisting in delayed weight-bearing Receives: Other: delayed weight-bearing for 6 weeks after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6
Functional ankle recovery is measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points.
The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 6 (visit 3).
A negative change from the day of surgery to week 6 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.
Measured: baseline and week 6
Secondary outcomes (12)
change in subjective functional ankle recovery on the Olerud-Molander Ankle Score during the first 24 weeks after surgery
measured using the OMAS score at 2, 12 and 24 weeks postoperatively. measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points.
The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 2 (visit 2), 12 (visit 4) and 24 (visit 5). A negative change from the day of surgery to week 2, 12 or 24 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.
Measured: baseline, week2, week 12 and week 24
Change form day of surgery in functional ankle disability on the Foot and Ankle Disability Index (FADI) during the first 24 weeks after surgery
measured using the Foot and Ankle Disability Index (FADI) at 2, 6, 12 and 24 weeks postoperatively.
FADI is designed to assess functional limitations related to foot and ankle conditions. FADI consists of 4 pain-related and 22 activity-related items) for a total of 26.
Each of the 22 activity-related items is scored on a 5-point Likert scale from 0 (unable to do) to 4 (no difficulty at all). The 4 pain-items are scored from 0 (none) to 4 (unbearable). The total FADI score is calculated as percentages, with 100% representing no ankle dysfunction.
The FADI questionnaire will be administered after surgery (visit 1, day 1) and at week 2, (visit 2), 6 (visit 3), 12 (visit 4) and 24 (visit 5).
A positive change from the day of surgery to week 2, 6, 12 or 24 will indicate an improvement in FADI score and, therefore, in functional ankle disability.
Measured: baseline, 2, 6, 12 and 24 weeks
Change form baseline in pain on the Numerical Rating Scale (NRS)
measured by using a Numerical Rating Scale (NRS) at 12 and 24 weeks postoperatively.
The pain NRS is a self-assessment scale in which patients rate their pain on an 11-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The pain NRS will be administered after surgery (visit 1, day 1) and at 12 (visit 4) and 24 (visit 5).
A negative change from the day of surgery to week 12 or 24 will indicate an improvement in pain NRS score and, therefore, in local pain.
Measured: baseline, 12 and 24 weeks
Daily pain and function
monitored through mobile NRS application up to 12 weeks postoperatively. A new application suitable for the use with both Android and iOS running mobile phones was developed by our Institution (EOC- Ente Osedaliero Cantonale) , namely "EOC - EMApp". The application asks the patients two simple questions: to rate actual pain and function on a 0-10 NRS two times daily at random hours in the morning and the evening, as suggested by previous experiences. The following parameters will be calculated and compared between groups: average daily pain and function, mean value of pain and function for each week and for the entire period of assessment (12 weeks). If the patient does not have a smartphone, he/she will not be included it in this assessment group.
Measured: 12 weeks
change in quality of life on the 36-Item Short Form Health Survey (SF-36 questionnaire).
measured from the day of surgery (Day 1) to 2, 6, 12 and 24 weeks postoperatively by a using the SF-36 questionnaire.
The SF-36 is a validated, self-administered questionnaire specifically designed for evaluating patient health-related quality of life. It comprises of 36 questions, relating to eight key areas of physical and psychological health, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The weighted-score of each area is transformed into a 0-100 scale, with lower scores indicating the more disability and higher scores the less disability.
A negative change from the day of surgery to week 2, 6, 12 or 24 will indicate an improvement in SF-36 score and, therefore, in quality of life.
Measured: baseline, 2, 6,12 and 24 weeks
Return to previous daily activities on the Tegner activity level scale
evaluated by using the Tegner score at 12 and 24 weeks postoperatively. The Tegner activity level scale is a patient-administered rating system designed to provide a standardized method of grading work and sporting activities. It consists of a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0 that represents sick leave or disability pension because of ankle problems to 10 that corresponds to participation in national and international elite competitive sports.
The Tegner activity level scale questionnaire will be administered at week 12 (visit 4) and 24 (visit 5).
A positive change from score before injury to post-operative score will indicate an improvement in Tegner activity level scale score and, therefore, a higher level of activity and return to previous daily activity.
Measured: week 12 and week 24
Objective ankle functional recovery
evaluated through gait analysis by using the OptoGait® at 6, 12, 24 weeks postoperatively.
The OptoGait® is an avant-garde laser and video technology that permits to quantitatively measure through a sophisticated software the symmetry of the steps, the weight-bearing area, the time of foot-rest on the ground and other parameters. The change of each of this parameter will be evaluated at week 6 (visit 3), 12 (visit 4), 24 (visit 5) to assess the ankle functional recovery during the rehabilitation intervention.
Measured: 6, 12, 24 weeks
Ankle joint flexibility
measured through the Ankle Range of Motion (ROM) assessed with a goniometer at 6, 12, 24 weeks postoperatively.
Measured: 6, 12, 24 weeks
Objective activity level
Objective activity level will be continuously documented through a wrist activity tracker measuring daily walking distance up to 24 weeks. The patient will receive the tracker after the surgery and wear it for 24 weeks. The tracker, then, will be returned to the hospital during visit 5.
Measured: 24 weeks
Radiological assessment
Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at week 6 (visit 3), 12 (visit 4), 24 (visit 5). X-ray at 24 weeks will be done only in case of fracture non-union reported at the 12-weeks post-operatively.
Measured: 24 weeks
Pain drug consumption
Pain drug consumption will be assessed by recording in a patient diary type and dosage of pain drugs, and reason for taking the drug from surgery (day 1, visit 1) up to 24 weeks (visit 5) postoperatively.
Drug consumption will be quantified in milligrams of active principle taken per week and in number of days in which the patient required a pain drugs during the study period.
Measured: 24 weeks
Patient satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
Patient satisfaction will be documented by using 0-10 NRS administered at 6, 12, 24 weeks postoperatively. The satisfaction NRS is a self-assessment scale in which patients rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery (visit 1, day 1) and at week 6 (visit 3), 12 (visit 4) and 24 (visit 5).
A positive change from the day of surgery to week 6, 12 or 24 will indicate an improvement in satisfaction NRS score and, therefore, in patient satisfaction.
Measured: day of surgery, week 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start28 Apr 2020
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Malleolus FractureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Adrian Testa, MD, Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429217
- Sponsor's protocol ID
- ORL-ORT-012
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2020
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04429217
- Acronym / sponsor ID
- ORL-ORT-012
- Conditions
- Lateral Malleolus Fracture
- Keywords
- Ankle, surgical treatment, malleolar fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 12 Jun 2020 (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.
The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing.
The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.
Detailed description
The study population corresponds to the patients who may benefit from a post-operative rehabilitation protocol with immediate weight-bearing. Eligible lateral malleolar fractures are limited to Weber A and Weber B fractures, since they have a higher stability, after open reduction and internal fixation, compared to Weber C and Maisonneuve fractures. This higher stability gives the possibility to evaluate the benefit of the immediate weight-bearing protocol without safety concerns.
A power analysis was performed to estimate the required sample size to detect a significant difference in the OMAS score at 6 weeks between groups: the number of patients needed is 42 patients per group (84 patients overall) but, considering the risk of drop-outs, the investigators plan to enroll 20% more patients for a total of 100 patients.
The surgical operation will be carried out following the AO Foundation general and specific rules concerning the surgical treatment of malleolar fractures . In particular,an anatomical open reduction and internal fixation with one or two compression screws sustained by a neutralization third-tubular plate for simple fractures or a bridging third-tubular locking compression plate for multi-fragmentary fractures will be performed.
Postoperatively, patients who still meet the eligibility criteria will be randomized in 2 groups: immediate post-operative complete weight-bearing and complete weight-bearing delayed for 6 weeks.Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids (patients will wear an ankle brace, this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement). Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery (also patients of the control group will wear the ankle brace).
Subsequent follow-up visits are scheduled at 2, 6, 12 and 24 weeks after surgery. Patients with a fracture non-union radiologically confirmed at week 24 will be followed up until 48 weeks after surgery. Clinical assessments will be performed using subjective, objective and radiological evaluations. Safety will be monitored throughout the study.
Overall study duration will be 2 years and 6 months (2 years to reach the expected sample size and 6 months to complete the follow-up):
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Other: immediate post-operative complete weight-bearing after surgeryexperimental post-operative rehabilitation intervention consisting in immediate weight-bearing |
| Arm-B | Active comparator | Other: delayed weight-bearing for 6 weeks after surgerycontrol post-operative rehabilitation intervention consisting in delayed weight-bearing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults
- Age ranging from 18 to 70 years, included
- Signed Informed Consent
- Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture
- Willingness and ability to participate in the trial
Key exclusion criteria (10 listed)
- Weber C fracture pattern
- Bilateral fractures or fractures in other locations
- Maissoneauve associated lesion
- Body Mass Index < 18.5 and ≥ 30
- Metabolic diseases influencing fracture healing processes
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 |
|---|---|---|
| immediate post-operative complete weight-bearing after surgeryPatients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement. | Other | Arm-A |
| delayed weight-bearing for 6 weeks after surgeryPatients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED). | Other | Arm-B |
Primary outcome
change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6
Time frame: baseline and week 6
Functional ankle recovery is measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points. The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 6 (visit 3). A negative change from the day of surgery to week 6 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.
12 secondary outcomes
change in subjective functional ankle recovery on the Olerud-Molander Ankle Score during the first 24 weeks after surgery
Time frame: baseline, week2, week 12 and week 24
Change form day of surgery in functional ankle disability on the Foot and Ankle Disability Index (FADI) during the first 24 weeks after surgery
Time frame: baseline, 2, 6, 12 and 24 weeks
Change form baseline in pain on the Numerical Rating Scale (NRS)
Time frame: baseline, 12 and 24 weeks
Daily pain and function
Time frame: 12 weeks
change in quality of life on the 36-Item Short Form Health Survey (SF-36 questionnaire).
Time frame: baseline, 2, 6,12 and 24 weeks
Return to previous daily activities on the Tegner activity level scale
Time frame: week 12 and week 24
Objective ankle functional recovery
Time frame: 6, 12, 24 weeks
Ankle joint flexibility
Time frame: 6, 12, 24 weeks
Objective activity level
Time frame: 24 weeks
Radiological assessment
Time frame: 24 weeks
Pain drug consumption
Time frame: 24 weeks
Patient satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
Time frame: day of surgery, week 6, 12 and 24
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 11 Sep 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.
Enrique Adrian Testa, MD principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate post-operative complete weight-bearing after surgery and delayed weight-bearing for 6 weeks after surgery in people with Lateral Malleolus Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 10 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 Switzerland. 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.
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?
Contact Enrique Adrian Testa, MD (+41 (0)91 811 69 31, enriqueadrian.testa@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6 (time frame: baseline and week 6). 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 11 Sep 2026.