An interventional study of Postoperative protocol (Immediate weight bearing) and Postoperative Protocol (Delayed Weight Bearing) in Ankle Fractures, sponsored by Kyle Schweser MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Kyle Schweser MD · Not applicable, Interventional, and Treatment
Among 60 studies in Ankle Fractures with a site in United States — 16 open to participants now, 20 under way, none of them phase 3. Ankle Fractures · United States.
Among the 60 studies in Ankle Fractures with a site in United States, this one is the 34th largest by planned enrollment of the 49 interventional ones that give a count, is one of 5 that started in 2020, is one of 37 with no phase, reaches primary completion later than 13 of the 19 other live ones, and was the 32nd registered.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
Browse Ankle Fractures studies →16 of the 60 studies in Ankle Fractures with a site in United States are open now. Recruiting first, the newest first:
Brian W. Noehren · Sites in United States
NYU Langone Health · Sites in United States
Jenna-Leigh Wilson · Sites in United States
University of Kansas Medical Center · Sites in United States
Maimonides Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 31 Ankle Fractures studies recruiting now, 14 (45%) set no upper age limit and 12 (39%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
60 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 5 started in 2020.
This study's planned enrollment of 25 is below the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Median enrollment 55 across the 49 interventional studies, 76 across the 11 observational. Of the 30 that completed or were terminated, 13 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 60 have an industry lead sponsor. The 10 most frequent:
Kyle Schweser MD is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Kyle Schweser MD has 1 study filed under Ankle Fractures — fewer than ten, so there is no comparison to draw.
12 of the studies in Ankle Fractures with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05280639University of VirginiaSimplified Post Op Rehabilitation for Ankle and Pilon Fractures | 2026-12-01 |
| NCT06370325NYU Langone HealthNeuromuscular Electrical Stimulation in Foot and Ankle Surgery | 2026-12-30 |
| NCT04113044AO Innovation Translation CenterGo Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® | 2026-12-31 |
| NCT06085586Maimonides Medical CenterFibulink Syndesmosis Repair System With Early Full-Weight Bearing | 2026-12-31 |
| NCT05729542University of California, San DiegoComparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries | 2026-12-31 |
Among the 60 studies in Ankle Fractures with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores
Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores
Patients will be recruited from the trauma and foot \& ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled
The following protocol will be applied after enrollment
Pre-operatively
a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days.
1. Placement into short leg, non-weight bearing splint to allow for wound healing and brace fabrication ii. Research Specific:
1. Fitted for brace (will be custom made and take approximately 1-2 weeks) b. 2 week visit (standard of care timepoint) i. Standard of Care:
1. Placement into brace so it offloads the hindfoot to 15 pounds of pressure or less 2. Education by prosthetist, physiatrist, and/or attending physician about proper brace wear and maintenance, and the importance of weight bearing only in brace.
c. 3 Week visit (not standard of care timepoint) i. Research Specific
1. Ankle radiographs d. 4 weeks, 6 weeks, 12 Weeks, 26 weeks, and 1 year visits (standard of care time points) i. Standard of Care
1. Counseling regarding brace wear 2. Brace adjustments as needed e. 8 week, 10 week, 14 week, 16 week, (non-standard of care biweekly visits until healing occurs) i. Research Specific
Upon study completion, patients will continue with post-operative rehab following the surgeon's standard of care. If a patients is removed prematurely or if the study ends prematurely, they will receive standard of care procedures going forward
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
Other: Postoperative protocol (Immediate weight bearing)
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
Other: Postoperative Protocol (Delayed Weight Bearing)
After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace
After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol
Adverse Events
Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).
Time frame: 12 months
AAOS Foot and Ankle Score
The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed among five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
Time frame: 12 Months
PROMIS Score
The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).
Time frame: 12 Months
Plan to share: No — The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.
Started Aug 2020 (actual). Primary completion is estimated for Jun 2027, 82 months after the start.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 82 months is above that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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Kyle Schweser MD