Ankle ReconstructionBFRankle reconNCT07451210
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
A study testing blood flow restriction in people with Ankle Reconstruction and Blood Flow Restriction Therapy, run by Texas Tech University Health Sciences Center at 5 sites in United States.
Trial summary
The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Reconstruction, Blood Flow Restriction Therapy, Physical Therapy
- What is being tested?
- blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Mar 2026to 31 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
- Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.
Who cannot join
- Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
- Autoimmune disorders.
- History of stroke or deep vein thrombosis (DVT).
- Bleeding or coagulation disorders.
- Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
- Pregnancy (current or planning to become pregnant in the next 4 months)
Show all 12Show fewer
- Malignancy (cancer).
- Professional athletes.
- Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
- Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
- Be deemed unsuitable for inclusion in the study at the discretion of the Investigators
- Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 2 recruiting
- Active, not recruiting
Physical Therapy Today (PTT)
Lubbock, Texas, 79407
- Active, not recruiting
University Medical Center
Lubbock, Texas, 79415
- Active, not recruiting
Northstar Surgery Center
Lubbock, Texas, 79416
- Recruiting
The Center for Orthopedic Surgery
Lubbock, Texas, 79416
Kenneth Stephenson, MD, (806) 797-4985, ken4feet@aol.com
Kenneth Stephenson, MD
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Jerry Grimes MD, MD, +18067432465, Jerry.Grimes@ttuhsc.edu
Jenny Hudnall, MS BME, jennifer.hudnall@ttuhsc.edu
About this study
The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention.
Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups.
Read more
Outcome measures of interest include:
- muscle atrophy;
- ankle function;
- fatigability/manual muscle testing;
- pain scores;
- cardiovascular effects (heart rate, blood pressure).
Read the detailed description
Study Aims:
To evaluate the efficacy of Blood Flow Restriction (BFR) therapy compared to the current standard of care (SOC) in improving muscle atrophy, strength recovery, ankle functionality, and pain management in patients undergoing rehabilitation after ankle ligament reconstruction.
Objectives:
Evaluate Muscle Atrophy: To compare the extent of muscle recovery in the quadriceps and gastrocnemius muscles between patients receiving BFR therapy and those receiving the current standard of care. This will be done by comparing muscle circumference
Assess Fatigability Recovery: To determine whether BFR therapy accelerates the recovery of dynamic lower extremity fatigability more effectively than the current standard of care as measured by manual muscle testing (MMT)
Measure Functional Outcomes: To use the Foot and Ankle Disability Index (FADI) to evaluate improvements in ankle functionality and activities of daily living between the two treatment groups.
Monitor Pain Levels: To compare perceived pain levels during treatment and daily activities in patients undergoing BFR therapy versus those receiving standard care using a visual analog scale (VAS)
Analyze Cardiovascular Impact: To investigate changes in resting heart rate and blood pressure to identify any cardiovascular benefits associated with BFR therapy compared to the current standard of care
Study overview:
This study is designed as a randomized clinical trial to evaluate the efficacy of Blood Flow Restriction (BFR) therapy in postoperative rehabilitation following ankle ligament reconstruction.
Patients who have undergone ankle ligament reconstruction surgery performed by participating orthopedic surgeons will be randomized to either the treatment group (BFR therapy) or standard of care (SOC) group. Patients will then receive physical therapy (PT) managed by treatment physical therapists (t-PT). These therapists will perform BFR during the weekly PT sessions and provide the same at home exercises for participants in both groups. These physical therapists will not be part of the study team and will not collect study related data.
Patients in the treatment group will begin BFR therapy at least 28 days post-op (+7 days). The therapy will be performed on the affected limb, focusing on hip and knee strength, with ankle strengthening in plantarflexion and dorsiflexion in a seated position. Additional exercises include multi-joint hip and knee strengthening, such as straight leg raises, side-lying external rotation hip exercises (clam shells), short arc quads, long arc quads, hamstring curls, and hip bridges. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the physical therapist.
The SOC group will receive traditional physical therapy methods without BFR at least 28 days post-op (+ 7 days). The protocol will include similar exercises to those in the BFR group but without occlusion. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the t-PT.
Follow-up assessments and outcomes of interest will be collected by the study physical therapists (s-PT). s-PTs collecting study visit data will be blinded to the patient's treatment group. These measures include: muscle circumference (quadriceps and gastrocnemius), manual muscle testing (MMT) for fatigability recovery, Foot and Ankle Disability Index (FADI) for functional outcomes, pain levels using a visual analog scale (VAS), and cardiovascular measures (resting heart rate and blood pressure).
Assessments will be conducted at multiple time points for both the treatment and SOC groups:
Baseline: At initiation of physical therapy (28 days post-op + 7 days)) Visit 2: 63-70 days post-op Visit 3 (optional): At the end of the study (for patients continuing beyond the standard 6-weeks of physical therapy)
- Being tested
- blood flow restriction
- Keywords
- ankle reconstruction, physical therapy, blood flow restriction therapy, BFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionDevice
Also called BFR, Kaatsu
The intervention group will receive the standard of care PT performed with BFR on affected limb.
The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exercises prescribed by a licensed t-PT to perform under occlusion with a load of 30% of the subjects estimated 1-rep max.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) group | No intervention | standard course of physical therapy; no BFR |
| Blood flow restriction (BFR) group | Experimental | BFR device added during physical therapy Receives: Device: blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle atrophy measurement - gastrocnemius
Measurement location: maximal circumference of the gastrocnemius muscle Unit: cm Range: varies by participant
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Muscle atrophy measurement - quadriceps
Measurement location: 10 cm and 20 cm above the superior aspect of the patella Unit: cm Range: varies by participant
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Fatigability recovery using manual muscle testing (MMT)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care.
Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Foot and Ankle Disability Index (FADI)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care.
Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Pain Management - Visual analog scale
Measurement description: Pain will be assessed using a visual analog scale (VAS), rated from 0-10, and recorded during the study visits to help evaluate the effectiveness of BFR therapy in reducing pain during rehabilitation. They will also be verbally asked during each therapy session to ensure subject comfort.
Score range: 0 - 10 (higher score indicates higher levels of pain)
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Cardiovascular impact - heart rate
Measurement description: Resting heart rate will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits.
Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: beats per minute (bpm)
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Cardiovascular impact - blood pressure
Measurement description: Resting blood pressure will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits.
Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: systolic/diastolic in mmHg
Measured: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 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 Ankle ReconstructionStudies 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
- Model description
- Single blinded (assessor); Cohort study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Orthopedic Surgery, UMC Health System, H2 Health (Physical Therapy Today), Northstar Surgery Center
- Responsible party
- Principal investigator, Jerry Grimes, Texas Tech University Health Sciences Center
- Investigators
- Jerry Grimes, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451210
- Sponsor's protocol ID
- FY2024-335
- Acronym
- BFRankle recon
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07451210
- Acronym / sponsor ID
- BFRankle recon / FY2024-335
- Keywords
- ankle reconstruction, physical therapy, blood flow restriction therapy, BFR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- The Center for Orthopedic Surgery, UMC Health System, H2 Health (Physical Therapy Today), Northstar Surgery Center
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2026 (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 goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention.
Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups.
Outcome measures of interest include:
- muscle atrophy;
- ankle function;
- fatigability/manual muscle testing;
- pain scores;
- cardiovascular effects (heart rate, blood pressure).
Detailed description
Study Aims:
To evaluate the efficacy of Blood Flow Restriction (BFR) therapy compared to the current standard of care (SOC) in improving muscle atrophy, strength recovery, ankle functionality, and pain management in patients undergoing rehabilitation after ankle ligament reconstruction.
Objectives:
Evaluate Muscle Atrophy: To compare the extent of muscle recovery in the quadriceps and gastrocnemius muscles between patients receiving BFR therapy and those receiving the current standard of care. This will be done by comparing muscle circumference
Assess Fatigability Recovery: To determine whether BFR therapy accelerates the recovery of dynamic lower extremity fatigability more effectively than the current standard of care as measured by manual muscle testing (MMT)
Measure Functional Outcomes: To use the Foot and Ankle Disability Index (FADI) to evaluate improvements in ankle functionality and activities of daily living between the two treatment groups.
Monitor Pain Levels: To compare perceived pain levels during treatment and daily activities in patients undergoing BFR therapy versus those receiving standard care using a visual analog scale (VAS)
Analyze Cardiovascular Impact: To investigate changes in resting heart rate and blood pressure to identify any cardiovascular benefits associated with BFR therapy compared to the current standard of care
Study overview:
This study is designed as a randomized clinical trial to evaluate the efficacy of Blood Flow Restriction (BFR) therapy in postoperative rehabilitation following ankle ligament reconstruction.
Patients who have undergone ankle ligament reconstruction surgery performed by participating orthopedic surgeons will be randomized to either the treatment group (BFR therapy) or standard of care (SOC) group. Patients will then receive physical therapy (PT) managed by treatment physical therapists (t-PT). These therapists will perform BFR during the weekly PT sessions and provide the same at home exercises for participants in both groups. These physical therapists will not be part of the study team and will not collect study related data.
Patients in the treatment group will begin BFR therapy at least 28 days post-op (+7 days). The therapy will be performed on the affected limb, focusing on hip and knee strength, with ankle strengthening in plantarflexion and dorsiflexion in a seated position. Additional exercises include multi-joint hip and knee strengthening, such as straight leg raises, side-lying external rotation hip exercises (clam shells), short arc quads, long arc quads, hamstring curls, and hip bridges. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the physical therapist.
The SOC group will receive traditional physical therapy methods without BFR at least 28 days post-op (+ 7 days). The protocol will include similar exercises to those in the BFR group but without occlusion. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the t-PT.
Follow-up assessments and outcomes of interest will be collected by the study physical therapists (s-PT). s-PTs collecting study visit data will be blinded to the patient's treatment group. These measures include: muscle circumference (quadriceps and gastrocnemius), manual muscle testing (MMT) for fatigability recovery, Foot and Ankle Disability Index (FADI) for functional outcomes, pain levels using a visual analog scale (VAS), and cardiovascular measures (resting heart rate and blood pressure).
Assessments will be conducted at multiple time points for both the treatment and SOC groups:
Baseline: At initiation of physical therapy (28 days post-op + 7 days)) Visit 2: 63-70 days post-op Visit 3 (optional): At the end of the study (for patients continuing beyond the standard 6-weeks of physical therapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded (assessor); Cohort study
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) group | No intervention | –standard course of physical therapy; no BFR |
| Blood flow restriction (BFR) group | Experimental | Device: blood flow restrictionBFR device added during physical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
- Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.
Key exclusion criteria (12 listed)
- Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
- Autoimmune disorders.
- History of stroke or deep vein thrombosis (DVT).
- Bleeding or coagulation disorders.
- Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
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 |
|---|---|---|
| blood flow restrictionAlso: BFR, KaatsuThe intervention group will receive the standard of care PT performed with BFR on affected limb. The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exercises prescribed by a licensed t-PT to perform under occlusion with a load of 30% of the subjects estimated 1-rep max. | Device | Blood flow restriction (BFR) group |
Primary outcome
Muscle atrophy measurement - gastrocnemius
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement location: maximal circumference of the gastrocnemius muscle Unit: cm Range: varies by participant
Muscle atrophy measurement - quadriceps
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement location: 10 cm and 20 cm above the superior aspect of the patella Unit: cm Range: varies by participant
Fatigability recovery using manual muscle testing (MMT)
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Foot and Ankle Disability Index (FADI)
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Pain Management - Visual analog scale
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement description: Pain will be assessed using a visual analog scale (VAS), rated from 0-10, and recorded during the study visits to help evaluate the effectiveness of BFR therapy in reducing pain during rehabilitation. They will also be verbally asked during each therapy session to ensure subject comfort. Score range: 0 - 10 (higher score indicates higher levels of pain)
Cardiovascular impact - heart rate
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement description: Resting heart rate will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: beats per minute (bpm)
Cardiovascular impact - blood pressure
Time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)
Measurement description: Resting blood pressure will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: systolic/diastolic in mmHg
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 17 Mar 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.
Jerry Grimes, MD principal investigator
Texas Tech University Health Sciences Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood flow restriction in people with Ankle Reconstruction and Blood Flow Restriction Therapy, run by Texas Tech University Health Sciences Center at 5 sites 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 3 inclusion and 12 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Jenny Hudnall, MS BME (806-743-2260, jennifer.hudnall@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle atrophy measurement - gastrocnemius (time frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)). The study lists 7 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 17 Mar 2026.