Unstable Ankle Fractures With Syndesmotic DisruptionNCT05587842
Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption
A study testing Early Weightbearing management post operation and Delayed Weightbearing management post operation (Traditional) in people with Unstable Ankle Fractures With Syndesmotic Disruption, run by University of Arizona at 1 site in United States.
Trial summary
No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unstable Ankle Fractures With Syndesmotic Disruption
- What is being tested?
- Early Weightbearing management post operation and Delayed Weightbearing management post operation (Traditional)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ankle injury with unstable syndesmotic rupture, in the setting of isolated syndesmotic sprain, fibular fracture, bimalleolar, or trimalleolar equivalent ankle fracture
- Surgical fixation of syndesmosis and/or ankle within two weeks of injury
- Closed or low grade open (Gustilo-Anderson grade I \& II low-energy injuries without gross contamination) fractures
- Skeletally mature patients with closed physis
Who cannot join
- Previous ipsilateral ankle surgery
- Bilateral ankle fractures or concurrent other lower extremity injuries/major injuries that would affect recovery time
- Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient, developmental delay, etc.)
- Non-ambulatory pre-injury
- Tibial plafond fractures including articular impaction requiring elevation
- Peripheral neuropathy
- BMI over 45
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, 85006
About this study
Official title: Early Weightbearing vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption: A Randomized Controlled Trial
No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. This prospective study will attempt to determine if early weightbearing can improve functional outcomes, result in a quicker return to work, and monitor differences in rates of adverse events. It will exclude the most severe ankle injuries and patients with excluding comorbidities.
Read the detailed description
Fractures of the ankle are common injuries reported at around 10% of all fractures, with an incidence between 71-187/100,000 people/year. Rupture of the distal tibiofibular syndesmosis may occur alone or in association with ankle fractures. It is evident in approximately 10-23% of all patients with ankle fractures and approximately 20% of patients requiring internal fixation. Approximately 15/100,000 people sustain syndesmosis injuries each year, which can be associated with a variable degree of trauma to the soft-tissue and/or osseous structures that play an important role in ankle joint stability.
With syndesmotic injury, the goal of management is to restore and maintain the normal tibiofibular relationship to allow healing of the ligamentous structures of the syndesmosis. If syndesmotic injury is not detected nor treated long term, residual displacement of the ankle mortise will lead to persistent pain and early arthritis. Although most indications for surgical intervention for syndesmotic injuries are clear, certain elements of the post-operative protocol remain controversial. There is still controversy regarding using screws vs suture buttons to fix the syndesmosis, with studies showing similar functional outcomes and post-operative complications. However, screws have a significantly lower initial implant cost but inconclusive results on long term cost-effectiveness. For surgeons who use screws, two screws are better than one and recent literature shows that there is no need to remove screws routinely unless symptomatic. A recent systematic review shows there is little difference in functional outcome scores between immobilization versus early motion of surgically treated ankle fractures with syndesmotic injury. However, postoperative care in respect to when to initiate weightbearing still remains controversial.
Conventional postoperative care in regards to when to allow weightbearing varies by surgeon. Some prefer to keep the patient non-weightbearing for 6-12 weeks +/- immediate to early ankle motion, after which the patient begins protected weight bearing in a short leg walking cast for 2 weeks, followed by use of a soft ankle brace for 4-8 weeks. Others allow only touch toe weightbearing immediately postoperatively and only advance to full weight bearing once the syndesmosis screws have been removed, usually at 6 to 12 weeks. There is still no well-done evaluation to guide post op weightbearing.
A recent metanalysis of outcomes of early (EWB) versus delayed (DWB) postoperative weightbearing in patients undergoing surgical fixation of ankle fractures included seven randomized control trials, one quasi randomized trial, one prospective cohort study with retrospective matches, and one retrospective matched cohort study reported 10-point improvement in OMA scores at 6 weeks post-operatively for patients in the EWB group compared to the DWB group (p=0.02). With regards to time off work, there was a trend towards reduction of 15 days in the EWB group (p=0.08). Complication rates were similar, with no difference in rates of nonunion, malunion, or wound complications. Another systematic review does suggest that EWB after surgically treated ankle fractures would be appropriate for patients with good bone stock, minimal commination, and anatomical reduction, and may facilitate quicker rehabilitation and early return to work. Results show no significant difference in overall complication rates, including hardware failure, malunion, or nonunion. However, EWB may increase risk of superficial wound infection, but the studies had no statistical comparison.
There have been few studies to show outcomes of early protected weightbearing in patients who underwent surgical screw fixation of the syndesmosis. A recent retrospective review with 42 patients shows that EWB on a fixed syndesmosis appears to be safe, with no measurable clinical or radiographic consequences regarding ankle joint function. Even with screw breakage and loosening, loss of reduction was seldom observed. Another retrospective review was conducted on 89 patients who underwent open reduction internal fixation with syndesmotic stabilization using syndesmotic screws. The results showed maintenance of fracture reduction on all patients at 12 months and a complication rate of 11.7%, which is similar to previous early weightbearing trials on ankle fractures without syndesmotic stabilization.
No study has prospectively compared a traditional post-operative non-weightbearing protocol allowing ankle range of motion to early post-operative weightbearing as tolerated allowing ankle range of motion for unstable ankle injuries after surgical fixation of the syndesmosis. We will exclude the most severe injuries, including tibial plafond fractures with articular impaction and high-grade open ankle fractures. Implications of this study will be far reaching. Safe, early weightbearing will not only facilitate rehabilitation but it has been shown that early weightbearing reduces the time to return to work thus decreasing cost to the healthcare system and society.
- Being tested
- Early Weightbearing management post operation, Delayed Weightbearing management post operation (Traditional)
- Keywords
- Open reduction internal fixation, Syndesmotic fixation, Early weightbearing, Delayed weightbearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Weightbearing management post operationProcedure or surgery
Subjects will be instructed to be weightbearing, as tolerated, on their ankle starting at two weeks post operation.
Delayed Weightbearing management post operation (Traditional)Procedure or surgery
Subjects will be instructed to be non-weightbearing on their ankle until at least 6 weeks. After 6 weeks, the subject will be instructed to be weightbearing as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Non-weightbearing Group | Active comparator | At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to continue non-weightbearing w/ crutches. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, the subject will continue with non-weightbearing and follow range of motion instructions. After 6 weeks, the subject will begin weightbearing as tolerated. Instructions for limited range of motion to be given, and be weaned from orthosis.
At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation. Receives: Procedure: Delayed Weightbearing management post operation (Traditional) |
| Early weightbearing (as tolerated) Group | Experimental | At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, subject will continue with weightbearing as tolerated in orthosis, following range of motion instructions. After 6 weeks, the subject will continue with weightbearing as tolerated, and be weaned from orthosis.
At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation. Receives: Procedure: Early Weightbearing management post operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Exam Functional Outcomes
Functional outcomes will be measured through physical examinations. A patients range of motion will be assessed through dorsiflexion and plantarflexion, measured from neutral ankle position, and inversion and eversion will be tested as well.
Measured: Enrollment through 1 year
X-Ray Functional Outcomes
Additionally, functional outcomes will be assessed through x-rays. Nonunion diastasis will be defined as lack of complete cortical bridging between fragments on all radiographs. Malunion diastasis will be defined as loss of anatomic alignment on radiographs and asymmetry of the ankle clear spaces compared with the contralateral uninjured side. Symptomatic malunion diastasis will be defined as fracture union with malunion and subjective complaints including pain or instability with ambulation, weakness, fatigability, or neurologic symptoms.
Measured: Enrollment through 1 year
Loss of reduction of the syndesmosis
Loss of reduction of the syndesmosis will be determined with radiographs that show increased tibiofibular clear space, decreased tibiofibular overlap, and/or increased medial clear space.
Measured: Enrollment through 1 year
Olerud Molander
The Olerud score has nine categories regarding symptoms and function of the injured ankle. Patients are categorized by their individual sum scores: "poor" (0-30 points), "fair" (31-60 points.), "good" (61-90 points), and "excellent" (91-100 points).
Measured: Enrollment through 1 year
SF36
The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Enrollment through 1 year
patient satisfaction survey
The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Enrollment through 1 year
Secondary outcomes (1)
Difference in rates of Adverse Events
Assessment and identification of all AEs and complications will be reported on through the data collection forms. All events will be followed from date of onset through to outcome. Type, duration, management and/or treatment of events/complications will be recorded. Those complications requiring surgical management will also be recorded on data collection forms. Patients will be closely followed during their clinical course and if a complication should arise (i.e. nonunion/malunion, infection, loss of fixation, etc.) appropriate measures, which may include re-operation, will be employed at the surgeon's discretion.
Measured: Enrollment through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start10 Feb 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Ankle Fractures With Syndesmotic DisruptionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be enrolled and randomized into one of the two postoperative weightbearing groups: either the Non-weightbearing group, or the Early weightbearing.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McKee, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587842
- Sponsor's protocol ID
- 2011244166
- Status last verified
- May 2026
- First submitted
- 28 Sep 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This information will be kept in a secure locked location. Study information will only be shared with study personnel, and the IRB and other regulatory bodies (if needed). During randomization, a subject will be assigned a unique Subject ID to maintain confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weightbearing vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05587842
- Acronym / sponsor ID
- 2011244166
- Keywords
- Open reduction internal fixation, Syndesmotic fixation, Early weightbearing, Delayed weightbearing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Oct 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.
No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. This prospective study will attempt to determine if early weightbearing can improve functional outcomes, result in a quicker return to work, and monitor differences in rates of adverse events. It will exclude the most severe ankle injuries and patients with excluding comorbidities.
Detailed description
Fractures of the ankle are common injuries reported at around 10% of all fractures, with an incidence between 71-187/100,000 people/year. Rupture of the distal tibiofibular syndesmosis may occur alone or in association with ankle fractures. It is evident in approximately 10-23% of all patients with ankle fractures and approximately 20% of patients requiring internal fixation. Approximately 15/100,000 people sustain syndesmosis injuries each year, which can be associated with a variable degree of trauma to the soft-tissue and/or osseous structures that play an important role in ankle joint stability.
With syndesmotic injury, the goal of management is to restore and maintain the normal tibiofibular relationship to allow healing of the ligamentous structures of the syndesmosis. If syndesmotic injury is not detected nor treated long term, residual displacement of the ankle mortise will lead to persistent pain and early arthritis. Although most indications for surgical intervention for syndesmotic injuries are clear, certain elements of the post-operative protocol remain controversial. There is still controversy regarding using screws vs suture buttons to fix the syndesmosis, with studies showing similar functional outcomes and post-operative complications. However, screws have a significantly lower initial implant cost but inconclusive results on long term cost-effectiveness. For surgeons who use screws, two screws are better than one and recent literature shows that there is no need to remove screws routinely unless symptomatic. A recent systematic review shows there is little difference in functional outcome scores between immobilization versus early motion of surgically treated ankle fractures with syndesmotic injury. However, postoperative care in respect to when to initiate weightbearing still remains controversial.
Conventional postoperative care in regards to when to allow weightbearing varies by surgeon. Some prefer to keep the patient non-weightbearing for 6-12 weeks +/- immediate to early ankle motion, after which the patient begins protected weight bearing in a short leg walking cast for 2 weeks, followed by use of a soft ankle brace for 4-8 weeks. Others allow only touch toe weightbearing immediately postoperatively and only advance to full weight bearing once the syndesmosis screws have been removed, usually at 6 to 12 weeks. There is still no well-done evaluation to guide post op weightbearing.
A recent metanalysis of outcomes of early (EWB) versus delayed (DWB) postoperative weightbearing in patients undergoing surgical fixation of ankle fractures included seven randomized control trials, one quasi randomized trial, one prospective cohort study with retrospective matches, and one retrospective matched cohort study reported 10-point improvement in OMA scores at 6 weeks post-operatively for patients in the EWB group compared to the DWB group (p=0.02). With regards to time off work, there was a trend towards reduction of 15 days in the EWB group (p=0.08). Complication rates were similar, with no difference in rates of nonunion, malunion, or wound complications. Another systematic review does suggest that EWB after surgically treated ankle fractures would be appropriate for patients with good bone stock, minimal commination, and anatomical reduction, and may facilitate quicker rehabilitation and early return to work. Results show no significant difference in overall complication rates, including hardware failure, malunion, or nonunion. However, EWB may increase risk of superficial wound infection, but the studies had no statistical comparison.
There have been few studies to show outcomes of early protected weightbearing in patients who underwent surgical screw fixation of the syndesmosis. A recent retrospective review with 42 patients shows that EWB on a fixed syndesmosis appears to be safe, with no measurable clinical or radiographic consequences regarding ankle joint function. Even with screw breakage and loosening, loss of reduction was seldom observed. Another retrospective review was conducted on 89 patients who underwent open reduction internal fixation with syndesmotic stabilization using syndesmotic screws. The results showed maintenance of fracture reduction on all patients at 12 months and a complication rate of 11.7%, which is similar to previous early weightbearing trials on ankle fractures without syndesmotic stabilization.
No study has prospectively compared a traditional post-operative non-weightbearing protocol allowing ankle range of motion to early post-operative weightbearing as tolerated allowing ankle range of motion for unstable ankle injuries after surgical fixation of the syndesmosis. We will exclude the most severe injuries, including tibial plafond fractures with articular impaction and high-grade open ankle fractures. Implications of this study will be far reaching. Safe, early weightbearing will not only facilitate rehabilitation but it has been shown that early weightbearing reduces the time to return to work thus decreasing cost to the healthcare system and society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be enrolled and randomized into one of the two postoperative weightbearing groups: either the Non-weightbearing group, or the Early weightbearing.
| Arm | Type | Receives |
|---|---|---|
| Non-weightbearing Group | Active comparator | Procedure: Delayed Weightbearing management post operation (Traditional)At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to continue non-weightbearing w/ crutches. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, the subject will continue with non-weightbearing and follow range of motion instructions. After 6 weeks, the subject will begin weightbearing as tolerated. Instructions for limited range of motion to be given, and be weaned from orthosis. At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation. |
| Early weightbearing (as tolerated) Group | Experimental | Procedure: Early Weightbearing management post operationAt 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, subject will continue with weightbearing as tolerated in orthosis, following range of motion instructions. After 6 weeks, the subject will continue with weightbearing as tolerated, and be weaned from orthosis. At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral ankle injury with unstable syndesmotic rupture, in the setting of isolated syndesmotic sprain, fibular fracture, bimalleolar, or trimalleolar equivalent ankle fracture
- Surgical fixation of syndesmosis and/or ankle within two weeks of injury
- Closed or low grade open (Gustilo-Anderson grade I \& II low-energy injuries without gross contamination) fractures
- Skeletally mature patients with closed physis
Key exclusion criteria (7 listed)
- Previous ipsilateral ankle surgery
- Bilateral ankle fractures or concurrent other lower extremity injuries/major injuries that would affect recovery time
- Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient, developmental delay, etc.)
- Non-ambulatory pre-injury
- Tibial plafond fractures including articular impaction requiring elevation
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 |
|---|---|---|
| Early Weightbearing management post operationSubjects will be instructed to be weightbearing, as tolerated, on their ankle starting at two weeks post operation. | Procedure or surgery | Early weightbearing (as tolerated) Group |
| Delayed Weightbearing management post operation (Traditional)Subjects will be instructed to be non-weightbearing on their ankle until at least 6 weeks. After 6 weeks, the subject will be instructed to be weightbearing as tolerated. | Procedure or surgery | Non-weightbearing Group |
Primary outcome
Physical Exam Functional Outcomes
Time frame: Enrollment through 1 year
Functional outcomes will be measured through physical examinations. A patients range of motion will be assessed through dorsiflexion and plantarflexion, measured from neutral ankle position, and inversion and eversion will be tested as well.
X-Ray Functional Outcomes
Time frame: Enrollment through 1 year
Additionally, functional outcomes will be assessed through x-rays. Nonunion diastasis will be defined as lack of complete cortical bridging between fragments on all radiographs. Malunion diastasis will be defined as loss of anatomic alignment on radiographs and asymmetry of the ankle clear spaces compared with the contralateral uninjured side. Symptomatic malunion diastasis will be defined as fracture union with malunion and subjective complaints including pain or instability with ambulation, weakness, fatigability, or neurologic symptoms.
Loss of reduction of the syndesmosis
Time frame: Enrollment through 1 year
Loss of reduction of the syndesmosis will be determined with radiographs that show increased tibiofibular clear space, decreased tibiofibular overlap, and/or increased medial clear space.
Olerud Molander
Time frame: Enrollment through 1 year
The Olerud score has nine categories regarding symptoms and function of the injured ankle. Patients are categorized by their individual sum scores: "poor" (0-30 points), "fair" (31-60 points.), "good" (61-90 points), and "excellent" (91-100 points).
SF36
Time frame: Enrollment through 1 year
The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
patient satisfaction survey
Time frame: Enrollment through 1 year
The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
1 secondary outcome
Difference in rates of Adverse Events
Time frame: Enrollment through 1 year
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 22 May 2026.
- Individual participant dataSharing planned: No. This information will be kept in a secure locked location. Study information will only be shared with study personnel, and the IRB and other regulatory bodies (if needed). During randomization, a subject will be assigned a unique Subject ID to maintain confidentiality.
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 study testing Early Weightbearing management post operation and Delayed Weightbearing management post operation (Traditional) in people with Unstable Ankle Fractures With Syndesmotic Disruption, run by University of Arizona at 1 site in United States.
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 4 inclusion and 7 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 22 May 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 United States. 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?
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?
Physical Exam Functional Outcomes (time frame: Enrollment through 1 year). The study lists 6 primary outcomes in all. 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 22 May 2026.