Anterior Cruciate Ligament (ACL) TearNCT03364647
The Effect of Various Strength Training Protocols in ACL Reconstructed Participants
A study testing Arm A - blood flow restriction training in people with Anterior Cruciate Ligament (ACL) Tear and Physical Therapy, run by Brian W. Noehren at 2 sites in United States.
Trial summary
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear, Physical Therapy
- What is being tested?
- Arm A - blood flow restriction training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2017to 6 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACL tear and no previous ACL reconstruction on either the involved or other limb
Who cannot join
- Previous surgeries or conditions that might affect gait
- Any current condition other than ACL or meniscus injury which might affect gait
- Unable to provided informed consent
- Diabetic or have uncontrolled hypertension
- Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
- Allergic to Betadine or Xylocaine HCL.
Show all 13Show fewer
- Taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa that may cause excess bleeding.
- Any implanted medical device
- A history of deep vein thrombosis, have a family history of deep vein thrombosis, or varicose veins
- Spinal fusion
- Inability able to attend regular physical therapy or study visits
- Injury occurring more than ten weeks prior to study enrollment
- Not skeletally mature (growth plates not closed)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky Orthopaedics and Sports Medicine Center
Lexington, Kentucky, 40504
University of Kentucky BioMotion Laboratory, 725 Rose Street
Lexington, Kentucky, 40536-0082
About this study
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working.
There will be no charge to the participant for their physical therapy visits as long as they are part of the study
Read more
The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires).
The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form.
The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.
Read the detailed description
The following procedures may be performed.
Training sessions: Participants will be randomly assigned one of two groups. Assignments to which group are determined by random assignment based upon participant's number. One group will receive standard of care and the other will receive standard of care plus blood flow restriction training.
The air bands will then be placed on the participant's thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed and as the participant's impairments dictate. The investigator will also provide an educational program at regular intervals on the injury and recovery.
Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will be placed around the thigh. A second strap will be placed around the bottom of their lower leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will control movements and apply force at several different speeds and in a isometric mode.
Motion Analysis: Motion analysis will provide a means for evaluating motion of the participant's hip, knee and ankle joints during walking and jogging on the treadmill. Participants will have reflective markers placed on certain landmarks of their legs and lower back to allow the motion analysis system to record their trunk, hip, knee, and ankle movements. Markers will be applied with sticky tape to the skin and if necessary, athletic tape to limit marker movement during activities. A stationary trial will be collected to help the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds every minute. Participants will perform a series of jumps on both legs and on a single leg. In addition participants will be asked to go up and down step.
Treadmill Activity: Participants may walk on the treadmill as long as necessary to feel comfortable with it. Once ready, participants will walk at a self-selected warm up pace for 5 minutes. The investigator will then gradually increase the speed 1.5 m/s for 2 minutes each. The speed of the treadmill will then be increased gradually to a self-selected comfortable jogging\running pace for 2 minutes. Participants may request to stop at any time.
Muscle Biopsy: A small piece of muscle tissue will be removed from both of thighs. The muscle tissue will be taken from the outside of your thigh and will be taken about one hand width above your knee. A 1 inch by 1 inch portion of hair will possibly need to be shaved if necessary. The area of thigh will be numbed and a small ¼ inch incision will be made in the skin. A needle will then be briefly (lasting just a couple of seconds) inserted into the muscle to remove a .005 ounce piece of muscle (about the size of a pencil eraser). The incision will be pulled closed with a band-aid after the site is cleaned with an alcohol preparation and the participant's leg will be wrapped snugly with an elastic bandage. The procedure will last approximately 15 minutes. The tissue samples will be used in the analysis process. In addition, standard venipuncture methods will be used to collect one 7.5 mL tube of blood to be used for analysis.
Magnetic Resonance Imaging \& Spectroscopy Center: Participants will be asked to complete a medical screening questionnaire that will ask specific questions about their health and medical history. This information will be used to determine eligibility to participate in the study. At this time, the procedures and risks involved in participating in the research study will be explained to the individual. Participants will also fill out a questionnaire asking whether they have any metal in their body as well as any other medical conditions that may need to be considered before they enter the MRI scanner. The metal screening questionnaire will be reviewed by the individual operating the scanner and if any risks are identified, the participant may not be able to participate.
Participants will be taken to the MRI scanner by the experimenter. Participants will be asked to remove all jewelry, body piercings, hair accessories, belts, wallets, credit cards, and loose change and leave these items with the experimenter. Participants will then be instructed about specific MRI procedures.
The magnetic resonance scanning will take approximately 60 minutes per leg. Participants will be asked to lie still during the scanning.
- Being tested
- Arm A - blood flow restriction training, Arm B - standard of care
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A - blood flow restriction trainingOther
Group receive standard of care plus blood flow restriction training
Arm B - standard of careOther
Group will receive standard of care plus a sham version of blood flow restriction training
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Blood flow restriction training | Experimental | Group will use blood flow restriction training and standard of care Receives: Other: Arm A - blood flow restriction training |
| Arm B - standard of care plus sham | Sham comparator | Group will receive standard of care plus a sham version of blood flow restriction training Receives: Other: Arm B - standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Change in Isometric Peak Torque Quadriceps Strength
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline, and post-surgery (up to 5 months)
Measure Change in Isokinetic Peak Torque Quadriceps Strength
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline and post-surgery (up to 5 months)
Measure Change in Rate of Torque Development
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline and post-surgery (up to 5 months)
Secondary outcomes (4)
Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline, Post-surgery (up to 5 months)
Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA)
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline, Post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Peak Knee Flexion
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline and post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM)
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measured: Baseline and post-surgery (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start21 Aug 2017
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies 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
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian W. Noehren
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Brian W. Noehren, University of Kentucky
- Investigators
- Brian Noehren, PT., Ph.D, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364647
- Sponsor's protocol ID
- 15-0750-F6A
- Other IDs
- R01AR071398
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2017
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
PubMed 39350350Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.
PubMed 30951598
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Various Strength Training Protocols in ACL Reconstructed Participants
- ClinicalTrials.gov ID
- NCT03364647
- Acronym / sponsor ID
- 15-0750-F6A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Brian W. NoehrenUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working.
There will be no charge to the participant for their physical therapy visits as long as they are part of the study
The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires).
The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form.
The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.
Detailed description
The following procedures may be performed.
Training sessions: Participants will be randomly assigned one of two groups. Assignments to which group are determined by random assignment based upon participant's number. One group will receive standard of care and the other will receive standard of care plus blood flow restriction training.
The air bands will then be placed on the participant's thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed and as the participant's impairments dictate. The investigator will also provide an educational program at regular intervals on the injury and recovery.
Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will be placed around the thigh. A second strap will be placed around the bottom of their lower leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will control movements and apply force at several different speeds and in a isometric mode.
Motion Analysis: Motion analysis will provide a means for evaluating motion of the participant's hip, knee and ankle joints during walking and jogging on the treadmill. Participants will have reflective markers placed on certain landmarks of their legs and lower back to allow the motion analysis system to record their trunk, hip, knee, and ankle movements. Markers will be applied with sticky tape to the skin and if necessary, athletic tape to limit marker movement during activities. A stationary trial will be collected to help the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds every minute. Participants will perform a series of jumps on both legs and on a single leg. In addition participants will be asked to go up and down step.
Treadmill Activity: Participants may walk on the treadmill as long as necessary to feel comfortable with it. Once ready, participants will walk at a self-selected warm up pace for 5 minutes. The investigator will then gradually increase the speed 1.5 m/s for 2 minutes each. The speed of the treadmill will then be increased gradually to a self-selected comfortable jogging\running pace for 2 minutes. Participants may request to stop at any time.
Muscle Biopsy: A small piece of muscle tissue will be removed from both of thighs. The muscle tissue will be taken from the outside of your thigh and will be taken about one hand width above your knee. A 1 inch by 1 inch portion of hair will possibly need to be shaved if necessary. The area of thigh will be numbed and a small ¼ inch incision will be made in the skin. A needle will then be briefly (lasting just a couple of seconds) inserted into the muscle to remove a .005 ounce piece of muscle (about the size of a pencil eraser). The incision will be pulled closed with a band-aid after the site is cleaned with an alcohol preparation and the participant's leg will be wrapped snugly with an elastic bandage. The procedure will last approximately 15 minutes. The tissue samples will be used in the analysis process. In addition, standard venipuncture methods will be used to collect one 7.5 mL tube of blood to be used for analysis.
Magnetic Resonance Imaging \& Spectroscopy Center: Participants will be asked to complete a medical screening questionnaire that will ask specific questions about their health and medical history. This information will be used to determine eligibility to participate in the study. At this time, the procedures and risks involved in participating in the research study will be explained to the individual. Participants will also fill out a questionnaire asking whether they have any metal in their body as well as any other medical conditions that may need to be considered before they enter the MRI scanner. The metal screening questionnaire will be reviewed by the individual operating the scanner and if any risks are identified, the participant may not be able to participate.
Participants will be taken to the MRI scanner by the experimenter. Participants will be asked to remove all jewelry, body piercings, hair accessories, belts, wallets, credit cards, and loose change and leave these items with the experimenter. Participants will then be instructed about specific MRI procedures.
The magnetic resonance scanning will take approximately 60 minutes per leg. Participants will be asked to lie still during the scanning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Arm A - Blood flow restriction training | Experimental | Other: Arm A - blood flow restriction trainingGroup will use blood flow restriction training and standard of care |
| Arm B - standard of care plus sham | Sham comparator | Other: Arm B - standard of careGroup will receive standard of care plus a sham version of blood flow restriction training |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ACL tear and no previous ACL reconstruction on either the involved or other limb
Key exclusion criteria (13 listed)
- Previous surgeries or conditions that might affect gait
- Any current condition other than ACL or meniscus injury which might affect gait
- Unable to provided informed consent
- Diabetic or have uncontrolled hypertension
- Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
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 |
|---|---|---|
| Arm A - blood flow restriction trainingGroup receive standard of care plus blood flow restriction training | Other | Arm A - Blood flow restriction training |
| Arm B - standard of careGroup will receive standard of care plus a sham version of blood flow restriction training | Other | Arm B - standard of care plus sham |
Primary outcome
Measure Change in Isometric Peak Torque Quadriceps Strength
Time frame: Baseline, and post-surgery (up to 5 months)
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measure Change in Isokinetic Peak Torque Quadriceps Strength
Time frame: Baseline and post-surgery (up to 5 months)
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measure Change in Rate of Torque Development
Time frame: Baseline and post-surgery (up to 5 months)
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
4 secondary outcomes
Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time
Time frame: Baseline, Post-surgery (up to 5 months)
Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA)
Time frame: Baseline, Post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Peak Knee Flexion
Time frame: Baseline and post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM)
Time frame: Baseline and post-surgery (up to 5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39350350Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.
- Derived from this study: PubMed 30951598Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.
- 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. This study is not recruiting at the moment.
Brian Noehren, PT., Ph.D principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A - blood flow restriction training in people with Anterior Cruciate Ligament (ACL) Tear and Physical Therapy, run by Brian W. Noehren at 2 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 1 inclusion and 13 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: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure Change in Isometric Peak Torque Quadriceps Strength (time frame: Baseline, and post-surgery (up to 5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364647, which also lists 2 linked publications.
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 13 Jan 2025.