Anterior Cruciate Ligament RuptureBFRNCT03758755
Blood Flow Restriction Following ACL Reconstruction
A study testing Blood Flow Restriction Therapy and ACL Reconstruction rehabilitation in people with Anterior Cruciate Ligament Rupture, run by Inova Health Care Services at 1 site in United States.
Trial summary
The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Blood Flow Restriction Therapy and ACL Reconstruction rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 26 Oct 2022
- 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-35 years at the time of surgery
- Anterior Cruciate Ligament (ACL) reconstruction
- Using a physical therapy center with Blood Flow Restriction capabilities.
Who cannot join
- Concomitant ligament reconstruction
- Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
- History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
- Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
- History of coagulation disorders or current use of anticoagulants
- Completion of physical therapy at a location not affiliated with the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction
The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.
Read the detailed description
Recovery from anterior cruciate ligament (ACL) reconstruction involves early physical therapy to promote muscular development. Traditional training regimens are based on the concept that muscle growth is induced with high resistance exercises of at least 65-70% of 1-repetition maximum. Achieving a high resistance level can be challenging in the early post-surgical patient who may be limited by pain, muscle atrophy, diminished proprioception, and psychological factors. Increasing evidence has suggested that Blood Flow Restriction (BFR) in resistance training, while transmitting a decreased load (25-50% of 1-repetition maximum) across the surgical site, may provide an additional benefit of inducing muscular development similar to that of high intensity exercises .
Augmenting exercises with BFR involves an external pressure cuff applied to the proximal portion of the extremity, which is inflated to a pressure that restricts venous outflow while allowing arterial inflow to continue. This creates a physiologic environment for the patient to gain the hypertrophic effect of high resistance training, though at a lower and safer intensity. Studies suggest that BFR stimulates muscular development through an increase in metabolic stress, muscle fiber recruitment, cell swelling, and protein synthesis.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Blood Flow Restriction Therapy, ACL Reconstruction rehabilitation
- Keywords
- BFR, ACL, rehabilitation
- 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 TherapyDevice
A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitationOther
post-operative rehabilitation according to current standards of care
| Study group | Role | What they receive |
|---|---|---|
| BFR Therapy | Experimental | This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks. Receives: Device: Blood Flow Restriction Therapy; Other: ACL Reconstruction rehabilitation |
| No BFR | Active comparator | This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR Receives: Other: ACL Reconstruction rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) Questionnaire Score
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: Measured preoperatively and at 12 weeks post-op.
Visual Analog Score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Measured: Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
Quadriceps Tendon Strength
We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Measured: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Thigh Circumference
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Measured: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of Knee Flexion
Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Measured: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of Knee Extension
Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.
Measured: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Secondary outcomes (1)
Adverse Effects
Observation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.
Measured: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2021
- Study completion26 Oct 2022
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 (8)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Chang, MD, Inova Health Care Services
- Investigators
- Edward Chang, MD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758755
- Sponsor's protocol ID
- 18-3150
- Acronym
- BFR
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2018
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PubMed 28259850Iversen E, Rostad V, Larmo A. Intermittent blood flow restriction does not reduce atrophy following anterior cruciate ligament reconstruction. J Sport Health Sci. 2016 Mar;5(1):115-118. doi: 10.1016/j.jshs.2014.12.005. Epub 2015 Apr 18.
PubMed 30356481Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
PubMed 12635796Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Blood flow restricted exercise for athletes: A review of available evidence. J Sci Med Sport. 2016 May;19(5):360-7. doi: 10.1016/j.jsams.2015.04.014. Epub 2015 May 9.
PubMed 26118847Suga T, Okita K, Takada S, Omokawa M, Kadoguchi T, Yokota T, Hirabayashi K, Takahashi M, Morita N, Horiuchi M, Kinugawa S, Tsutsui H. Effect of multiple set on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. Eur J Appl Physiol. 2012 Nov;112(11):3915-20. doi: 10.1007/s00421-012-2377-x. Epub 2012 Mar 14.
PubMed 22415101Takada S, Okita K, Suga T, Omokawa M, Morita N, Horiuchi M, Kadoguchi T, Takahashi M, Hirabayashi K, Yokota T, Kinugawa S, Tsutsui H. Blood flow restriction exercise in sprinters and endurance runners. Med Sci Sports Exerc. 2012 Mar;44(3):413-9. doi: 10.1249/MSS.0b013e31822f39b3.
PubMed 21795999Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
PubMed 10846023Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.
PubMed 19253083
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03758755
- Acronym / sponsor ID
- BFR / 18-3150
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- BFR, ACL, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.
Detailed description
Recovery from anterior cruciate ligament (ACL) reconstruction involves early physical therapy to promote muscular development. Traditional training regimens are based on the concept that muscle growth is induced with high resistance exercises of at least 65-70% of 1-repetition maximum. Achieving a high resistance level can be challenging in the early post-surgical patient who may be limited by pain, muscle atrophy, diminished proprioception, and psychological factors. Increasing evidence has suggested that Blood Flow Restriction (BFR) in resistance training, while transmitting a decreased load (25-50% of 1-repetition maximum) across the surgical site, may provide an additional benefit of inducing muscular development similar to that of high intensity exercises .
Augmenting exercises with BFR involves an external pressure cuff applied to the proximal portion of the extremity, which is inflated to a pressure that restricts venous outflow while allowing arterial inflow to continue. This creates a physiologic environment for the patient to gain the hypertrophic effect of high resistance training, though at a lower and safer intensity. Studies suggest that BFR stimulates muscular development through an increase in metabolic stress, muscle fiber recruitment, cell swelling, and protein synthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR Therapy | Experimental | Device: Blood Flow Restriction Therapy, Other: ACL Reconstruction rehabilitationThis group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks. |
| No BFR | Active comparator | Other: ACL Reconstruction rehabilitationThis group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 13-35 years at the time of surgery
- Anterior Cruciate Ligament (ACL) reconstruction
- Using a physical therapy center with Blood Flow Restriction capabilities.
Key exclusion criteria (7 listed)
- Concomitant ligament reconstruction
- Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
- History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
- Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
- History of coagulation disorders or current use of anticoagulants
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 TherapyA wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started. | Device | BFR Therapy |
| ACL Reconstruction rehabilitationpost-operative rehabilitation according to current standards of care | Other | BFR Therapy, No BFR |
Primary outcome
International Knee Documentation Committee (IKDC) Questionnaire Score
Time frame: Measured preoperatively and at 12 weeks post-op.
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Visual Analog Score
Time frame: Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Quadriceps Tendon Strength
Time frame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Thigh Circumference
Time frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Degrees of Knee Flexion
Time frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Degrees of Knee Extension
Time frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.
1 secondary outcome
Adverse Effects
Time frame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28259850Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
- Background: PubMed 30356481Iversen E, Rostad V, Larmo A. Intermittent blood flow restriction does not reduce atrophy following anterior cruciate ligament reconstruction. J Sport Health Sci. 2016 Mar;5(1):115-118. doi: 10.1016/j.jshs.2014.12.005. Epub 2015 Apr 18.
- Background: PubMed 12635796Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
- Background: PubMed 26118847Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Blood flow restricted exercise for athletes: A review of available evidence. J Sci Med Sport. 2016 May;19(5):360-7. doi: 10.1016/j.jsams.2015.04.014. Epub 2015 May 9.
- Background: PubMed 22415101Suga T, Okita K, Takada S, Omokawa M, Kadoguchi T, Yokota T, Hirabayashi K, Takahashi M, Morita N, Horiuchi M, Kinugawa S, Tsutsui H. Effect of multiple set on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. Eur J Appl Physiol. 2012 Nov;112(11):3915-20. doi: 10.1007/s00421-012-2377-x. Epub 2012 Mar 14.
- Background: PubMed 21795999Takada S, Okita K, Suga T, Omokawa M, Morita N, Horiuchi M, Kadoguchi T, Takahashi M, Hirabayashi K, Yokota T, Kinugawa S, Tsutsui H. Blood flow restriction exercise in sprinters and endurance runners. Med Sci Sports Exerc. 2012 Mar;44(3):413-9. doi: 10.1249/MSS.0b013e31822f39b3.
- Background: PubMed 10846023Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
- Background: PubMed 19253083Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.
- 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.
Edward Chang, MD principal investigator
Orthopedic Surgeon
1 site 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 Therapy and ACL Reconstruction rehabilitation in people with Anterior Cruciate Ligament Rupture, run by Inova Health Care Services at 1 site 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 7 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Dec 2022). 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?
International Knee Documentation Committee (IKDC) Questionnaire Score (time frame: Measured preoperatively and at 12 weeks post-op.). The study lists 6 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 NCT03758755, which also lists 8 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 22 Dec 2022.