ACL TearNCT04484961
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
A study testing Blood flow restriction (BFR) in people with ACL Tear, run by The Methodist Hospital Research Institute.
Trial summary
The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Tear
- What is being tested?
- Blood flow restriction (BFR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2016to 10 Jul 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-35
- Received ACL surgery with a patellar tendon autograft
Who cannot join
- Concomitant meniscal tear or additional ligamentous injury to the knee
- Obesity (BMI>30)
- Diabetes
- Cardiovascular, renal, liver or pulmonary disease
- Active infections
- Cancer (current or treated within the past 2 years) or coagulation disorder
Show all 10Show fewer
- Rapid weight change within the past year
- Physically unable to participate in the intervention
- Are not currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA. The NCAA banned substances list can be viewed from: http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs
- Unable to complete a minimum of 85% of the assigned rehabilitation sessions.
About this study
Official title: Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Read the detailed description
On the day of the procedure, the surgeon will measure the subject's thigh circumference 1/3 distance from the superior pole of the patella to the inguinal crease. The subject will then undergo the normal BTB autograft ACL reconstruction procedure. A subject will be excluded from the study if a meniscal repair is performed. At the subject's two week post-operative clinic visit, the physician will measure thigh circumference at 1/3 distance from the superior pole of the patella to the inguinal crease. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal ACL rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.
The BFR exercises will consist of: bilateral leg press week 3-10, eccentric leg press weeks 4-10, hamstring curl week 4-6, eccentric hamstring curl weeks 7-10, straight leg press weeks 6-10. The pressure used will be elevated to occluded blood flow by 80% (80% occlusion pressure) which will be determined for each individual subject. Subjects will do exercises at 20% of 1RM in 4 sets of 30-15-15-15 repetitions separated by 30 seconds of rest. Repetition maximum (1RM) will be determined by the contralateral leg, using the greatest amount of weight with full range of motion and proper form. This will be done over three separate tries, separated by one minute breaks. Resistance loads will be adjusted every 2 weeks as strength improves. During the exercise protocol, if patients are unable to complete the prescribed amount of repetitions, rest periods between sets will be increased as needed. The control group will do these exercises without BFR. Both study and control groups will also do the surgeons' standard post-ACL reconstruction physical therapy protocol.
Cuff pressures will be determined using the Loenneke et al outline, based off of thigh circumference and estimated cuff pressure for 50% artery occlusion [19].
Body composition (DEXA), bone density (DEXA), IKDC and Tegner Lysholm scores will be recorded at first rehabilitation visit, two weeks, eight weeks and 12 weeks following the initiation of rehab (1 wk following surgery). Y- balance, single leg squat distance, and single leg step down will be measured at 8 weeks and 12 weeks of rehab. Return to play will be recorded as the number of months after the day of operation until subject returns to sport.
- Conditions
- ACL Tear
- Being tested
- Blood flow restriction (BFR)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR)Device
The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control - Routine Rehab | No intervention | Participants in this group received standard ACL rehab with no blood flow restriction therapy. |
| Experimental - BFR | Experimental | Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy. Receives: Device: Blood flow restriction (BFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if BFR Changes Loss of LE Lean Muscle Mass
LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)
Measured: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Determine if BFR Changes Loss of Bone Mass
Bone mass was measured in grams using DEXA (iDXA, GE®)
Measured: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Determine if BFR Changes Loss of Bone Mineral Density
Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
Measured: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcomes (7)
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Single leg (SL) squat (best of 3 attempts)
Measured: Week 8 and Week 12 post-surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL eccentric step down (reps to fatigue or inadequate technique)
Measured: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance anterior (best of 3 attempts)
Measured: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posteromedial (best of 3 attempts)
Measured: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posterolateral (best of 3 attempts)
Measured: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL leg press (1RM)
Measured: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL hamstring curl (1RM)
Measured: 8 weeks post surgery, 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start18 Mar 2016
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
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 (30)Papers the sponsor has linked to this study.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
- Investigators
- Patrick McCulloch, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484961
- Sponsor's protocol ID
- Pro000138201
- Status last verified
- Oct 2024
- First submitted
- 13 Jul 2020
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
PubMed 16339340Abe T, Sakamaki M, Fujita S, Ozaki H, Sugaya M, Sato Y, Nakajima T. Effects of low-intensity walk training with restricted leg blood flow on muscle strength and aerobic capacity in older adults. J Geriatr Phys Ther. 2010 Jan-Mar;33(1):34-40.
PubMed 20503732Abe T, Yasuda T, Midorikawa T, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily "KAATSU" resistance training. Int J KAATSU Train Res. 2005;1(1):6-12
Anderson AW, Smith JJ. Proximal tibial fracture after patellar tendon autograft for ipsilateral ACL reconstruction. J Knee Surg. 2009 Apr;22(2):142-4. doi: 10.1055/s-0030-1247739.
PubMed 19476179Anderson MJ, Diko S, Baehr LM, Baar K, Bodine SC, Christiansen BA. Contribution of mechanical unloading to trabecular bone loss following non-invasive knee injury in mice. J Orthop Res. 2016 Oct;34(10):1680-1687. doi: 10.1002/jor.23178. Epub 2016 Feb 10.
PubMed 26826014Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.
PubMed 21098818Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
PubMed 28251287Bowman EN, El-shaar R, Milligan H, et al. The Proximal and Distal Effects of Blood Flow Restriction Therapy on Upper and Lower Extremity Strengthening: A Randomized Controlled Trial. Orthop J Sports Med. 2019;7(7_suppl5):2325967119S2325900337.
Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.
PubMed 17909396Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
PubMed 26446893Elkasrawy M, Immel D, Wen X, Liu X, Liang LF, Hamrick MW. Immunolocalization of myostatin (GDF-8) following musculoskeletal injury and the effects of exogenous myostatin on muscle and bone healing. J Histochem Cytochem. 2012 Jan;60(1):22-30. doi: 10.1369/0022155411425389.
PubMed 22205678Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PubMed 20150565Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.
PubMed 28500081Hamrick MW. A role for myokines in muscle-bone interactions. Exerc Sport Sci Rev. 2011 Jan;39(1):43-7. doi: 10.1097/JES.0b013e318201f601.
PubMed 21088601Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
PubMed 29879638
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04484961
- Acronym / sponsor ID
- Pro000138201
- Conditions
- ACL Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Detailed description
On the day of the procedure, the surgeon will measure the subject's thigh circumference 1/3 distance from the superior pole of the patella to the inguinal crease. The subject will then undergo the normal BTB autograft ACL reconstruction procedure. A subject will be excluded from the study if a meniscal repair is performed. At the subject's two week post-operative clinic visit, the physician will measure thigh circumference at 1/3 distance from the superior pole of the patella to the inguinal crease. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal ACL rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.
The BFR exercises will consist of: bilateral leg press week 3-10, eccentric leg press weeks 4-10, hamstring curl week 4-6, eccentric hamstring curl weeks 7-10, straight leg press weeks 6-10. The pressure used will be elevated to occluded blood flow by 80% (80% occlusion pressure) which will be determined for each individual subject. Subjects will do exercises at 20% of 1RM in 4 sets of 30-15-15-15 repetitions separated by 30 seconds of rest. Repetition maximum (1RM) will be determined by the contralateral leg, using the greatest amount of weight with full range of motion and proper form. This will be done over three separate tries, separated by one minute breaks. Resistance loads will be adjusted every 2 weeks as strength improves. During the exercise protocol, if patients are unable to complete the prescribed amount of repetitions, rest periods between sets will be increased as needed. The control group will do these exercises without BFR. Both study and control groups will also do the surgeons' standard post-ACL reconstruction physical therapy protocol.
Cuff pressures will be determined using the Loenneke et al outline, based off of thigh circumference and estimated cuff pressure for 50% artery occlusion [19].
Body composition (DEXA), bone density (DEXA), IKDC and Tegner Lysholm scores will be recorded at first rehabilitation visit, two weeks, eight weeks and 12 weeks following the initiation of rehab (1 wk following surgery). Y- balance, single leg squat distance, and single leg step down will be measured at 8 weeks and 12 weeks of rehab. Return to play will be recorded as the number of months after the day of operation until subject returns to sport.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.
| Arm | Type | Receives |
|---|---|---|
| Control - Routine Rehab | No intervention | –Participants in this group received standard ACL rehab with no blood flow restriction therapy. |
| Experimental - BFR | Experimental | Device: Blood flow restriction (BFR)Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 18-35
- Received ACL surgery with a patellar tendon autograft
Key exclusion criteria (10 listed)
- Concomitant meniscal tear or additional ligamentous injury to the knee
- Obesity (BMI>30)
- Diabetes
- Cardiovascular, renal, liver or pulmonary disease
- Active infections
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 restriction (BFR)The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises. | Device | Experimental - BFR |
Primary outcome
Determine if BFR Changes Loss of LE Lean Muscle Mass
Time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)
Determine if BFR Changes Loss of Bone Mass
Time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Bone mass was measured in grams using DEXA (iDXA, GE®)
Determine if BFR Changes Loss of Bone Mineral Density
Time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
7 secondary outcomes
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: Week 8 and Week 12 post-surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time frame: 8 weeks post surgery, 12 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16339340Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.
- Background: PubMed 20503732Abe T, Sakamaki M, Fujita S, Ozaki H, Sugaya M, Sato Y, Nakajima T. Effects of low-intensity walk training with restricted leg blood flow on muscle strength and aerobic capacity in older adults. J Geriatr Phys Ther. 2010 Jan-Mar;33(1):34-40.
- BackgroundAbe T, Yasuda T, Midorikawa T, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily "KAATSU" resistance training. Int J KAATSU Train Res. 2005;1(1):6-12
- Background: PubMed 19476179Anderson AW, Smith JJ. Proximal tibial fracture after patellar tendon autograft for ipsilateral ACL reconstruction. J Knee Surg. 2009 Apr;22(2):142-4. doi: 10.1055/s-0030-1247739.
- Background: PubMed 26826014Anderson MJ, Diko S, Baehr LM, Baar K, Bodine SC, Christiansen BA. Contribution of mechanical unloading to trabecular bone loss following non-invasive knee injury in mice. J Orthop Res. 2016 Oct;34(10):1680-1687. doi: 10.1002/jor.23178. Epub 2016 Feb 10.
- Background: PubMed 21098818Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.
- Background: PubMed 28251287Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
- BackgroundBowman EN, El-shaar R, Milligan H, et al. The Proximal and Distal Effects of Blood Flow Restriction Therapy on Upper and Lower Extremity Strengthening: A Randomized Controlled Trial. Orthop J Sports Med. 2019;7(7_suppl5):2325967119S2325900337.
- Background: PubMed 17909396Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.
- Background: PubMed 26446893Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
- Background: PubMed 22205678Elkasrawy M, Immel D, Wen X, Liu X, Liang LF, Hamrick MW. Immunolocalization of myostatin (GDF-8) following musculoskeletal injury and the effects of exogenous myostatin on muscle and bone healing. J Histochem Cytochem. 2012 Jan;60(1):22-30. doi: 10.1369/0022155411425389.
- Background: PubMed 20150565Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
- 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.
Patrick McCulloch, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) in people with ACL Tear, run by The Methodist Hospital Research Institute.
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 2 inclusion and 10 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 25 Nov 2024. 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. 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 25 Nov 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?
Determine if BFR Changes Loss of LE Lean Muscle Mass (time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery). 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 NCT04484961, which also lists 30 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 25 Nov 2024.