Lower Extremity FracturePhase 3NCT07155447
Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation
A Phase 3 study testing CEAA supplementation in people with Lower Extremity Fracture, run by University of Minnesota.
Trial summary
The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- CEAA supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 31 Dec 2027
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults age 18-55 years
- Open or closed fracture of the lower extremity including femur, tibia and/or fibula, calcaneus, talus, Lisfranc joint (OTA/AO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)
- Ability to begin supplementation within 72 hours of injury
Who cannot join
- BMI <18.5 kg/m 2 (underweight) or BMI > 45 kg/m 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition
- Non-ambulatory prior to injury
- Currently pregnant
- Medical contraindication to CEAA supplementation (e.g., phenylketonuria)
- Inability to provide informed consent due to intellectual disability
- Protected populations (e.g., prisoners)
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- Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)
- Documented dementia, mild or moderate traumatic brain injury
- Inability to consume supplement or placebo due to head or neck trauma
- Low-energy fragility fracture (i.e. ground level falls)
- Pathologic fracture (i.e. fracture through site of compromised bone due to infection, neoplasm, documented osteoporosis, metabolic bone disease from conditions such as end stage renal disease, osteomalacia, hypophosphatemic rickets, renal osteodystrophy, osteofibrous dysplasia)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Doris Stuber contact
About this study
The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.
- Conditions
- Lower Extremity Fracture
- Being tested
- CEAA supplementation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEAA supplementationDietary supplement
(including calcium beta-hydroxy-beta- methylbutyrate monohydrate, L-Arginine, L-Glutamine and Ciltruline) Supplementation will be started within 72 hours of presentation and continued for a period of 28 days.
PlaceboOther
a neutral powder containing the non- essential amino acid Alanine which will be indistinguishable from the CEAA supplement powder in in regards to packaging and supplement appearance.
| Study group | Role | What they receive |
|---|---|---|
| Patients randomized to CEAA | Experimental | Patients with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers Receives: Dietary Supplement: CEAA supplementation |
| patients randomized to placebo | Placebo comparator | Patients with with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation.
Investigators will record the number of participants with fracture-related infection for 12 months following lower extremity fracture fixation. The measurement will be based on Metsemakers consensus definition (Metsemakers et al. (2018). We will enroll 1,000 participants and anticipate 15% loss to attrition (426 in each arm).
Using the observed fracture-related infection rates of 16.5% and 10% from a previous study, 426 participants would be needed for each group to detect a significant difference with 80% power and alpha value of 0.05 based upon Pearson Chi-Square test and pooled standard deviation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start4 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Hendrickson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155447
- Sponsor's protocol ID
- 33444
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation
- ClinicalTrials.gov ID
- NCT07155447
- Acronym / sponsor ID
- 33444
- Conditions
- Lower Extremity Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2025 (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 objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients randomized to CEAA | Experimental | Dietary Supplement: CEAA supplementationPatients with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers |
| patients randomized to placebo | Placebo comparator | Other: PlaceboPatients with with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults age 18-55 years
- Open or closed fracture of the lower extremity including femur, tibia and/or fibula, calcaneus, talus, Lisfranc joint (OTA/AO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)
- Ability to begin supplementation within 72 hours of injury
Key exclusion criteria (11 listed)
- BMI <18.5 kg/m 2 (underweight) or BMI > 45 kg/m 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition
- Non-ambulatory prior to injury
- Currently pregnant
- Medical contraindication to CEAA supplementation (e.g., phenylketonuria)
- Inability to provide informed consent due to intellectual disability
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 |
|---|---|---|
| CEAA supplementation(including calcium beta-hydroxy-beta- methylbutyrate monohydrate, L-Arginine, L-Glutamine and Ciltruline) Supplementation will be started within 72 hours of presentation and continued for a period of 28 days. | Dietary supplement | Patients randomized to CEAA |
| Placeboa neutral powder containing the non- essential amino acid Alanine which will be indistinguishable from the CEAA supplement powder in in regards to packaging and supplement appearance. | Other | patients randomized to placebo |
Primary outcome
Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation.
Time frame: 12 months
Investigators will record the number of participants with fracture-related infection for 12 months following lower extremity fracture fixation. The measurement will be based on Metsemakers consensus definition (Metsemakers et al. (2018). We will enroll 1,000 participants and anticipate 15% loss to attrition (426 in each arm). Using the observed fracture-related infection rates of 16.5% and 10% from a previous study, 426 participants would be needed for each group to detect a significant difference with 80% power and alpha value of 0.05 based upon Pearson Chi-Square test and pooled standard deviation.
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 3 Sep 2026.
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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.
Doris Stuber contact
Nathan Hendrickson principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CEAA supplementation in people with Lower Extremity Fracture, run by University of Minnesota.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Paula Rupp (612-626-3952, mill3725@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation. (time frame: 12 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 3 Sep 2026.