Meniscus DisorderNCT04436523
Blood Flow Restriction After Meniscus Repair
A study testing Blood flow restriction (Delfi Personalized Tourniquet System) and Standard rehabilitation in people with Meniscus Disorder and Meniscus, Torn Tibial, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion
- What is being tested?
- Blood flow restriction (Delfi Personalized Tourniquet System) and Standard rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 8 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who undergo surgery for arthroscopic meniscus repair
Who cannot join
- Participants undergoing surgery for concomitant ligamentous surgeries
- Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
Read the detailed description
The investigators will conduct a double-blinded, single-institution, randomized controlled trial to compare patients undergoing arthroscopic meniscus repair with post-operative rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative extremity versus (2) blood flow restriction training with cuff occlusion applied to the operative extremity. Patients will be enrolled prospectively and pre-operatively at their initial clinic visit after meniscus injury.
Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.
- Conditions
- Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion, Meniscus Tear, Tibial, Atrophy, Muscular
- Being tested
- Blood flow restriction (Delfi Personalized Tourniquet System), Standard rehabilitation
- Keywords
- blood flow restriction, rehabilitation, meniscus repair
- Medical subject headings
- Tibial Meniscus Injuries, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (Delfi Personalized Tourniquet System)Device
Also called Delfi Personalized Tourniquet System
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Standard rehabilitationOther
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction | Experimental | The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine. Receives: Device: Blood flow restriction (Delfi Personalized Tourniquet System); Other: Standard rehabilitation |
| Standard rehabilitation | Sham comparator | The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow. Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Extension Force at Week 1
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 2
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 3
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 4
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 5
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 6
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 7
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 8
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 9
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 10
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 11
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Knee Extension Force at Week 12
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Measured: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 1
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 2
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 3
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 4
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 5
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 6
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 7
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 8
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 9
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 10
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 11
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Thigh Circumference at Week 12
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Measured: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Secondary outcomes (9)
International Knee Documentation Committee (IKDC) Score at Week 6
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Measured: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
International Knee Documentation Committee (IKDC) Score at Week 12
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Measured: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
International Knee Documentation Committee (IKDC) Score at Week 24
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Measured: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
Y-balance Testing at Week 12
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in centimeters in each direction) / (3*limb length) * 100.
Measured: 3 months (performed at 3 months and 6 months post-operatively)
Y-balance Testing at Week 24
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in centimeters in each direction) / (3*limb length) * 100.
Measured: 6 months (performed at 3 months and 6 months post-operatively)
3-hop Test at Week 12
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
Measured: 3 months (performed at 3 months and 6 months post-operatively)
3-hop Test at Week 24
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in meters.
Measured: 6 months (performed at 3 months and 6 months post-operatively)
Single Leg Squat Testing at Week 12
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation \& tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Measured: 3 months (performed at 3 months and 6 months post-operatively)
Single Leg Squat Testing at Week 24
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation \& tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Measured: 6 months (performed at 3 months and 6 months post-operatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start20 Oct 2020
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Why it stopped: We had difficulty with enrolling enough participants. We looked to include patients undergoing isolated meniscus repair surgery doing PT with our group and this group proved to be too small to enroll enough patients.
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.
- Other trials for Meniscus DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sachin Allahabadi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436523
- Sponsor's protocol ID
- 19-29641
- Status last verified
- Feb 2026
- First submitted
- 15 Jun 2020
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
- ClinicalTrials.gov ID
- NCT04436523
- Acronym / sponsor ID
- 19-29641
- Conditions
- Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion, Meniscus Tear, Tibial, Atrophy, Muscular
- Keywords
- blood flow restriction, rehabilitation, meniscus repair
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We had difficulty with enrolling enough participants. We looked to include patients undergoing isolated meniscus repair surgery doing PT with our group and this group proved to be too small to enroll enough patients.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Posted 20 Feb 2026
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 this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
Detailed description
The investigators will conduct a double-blinded, single-institution, randomized controlled trial to compare patients undergoing arthroscopic meniscus repair with post-operative rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative extremity versus (2) blood flow restriction training with cuff occlusion applied to the operative extremity. Patients will be enrolled prospectively and pre-operatively at their initial clinic visit after meniscus injury.
Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction | Experimental | Device: Blood flow restriction (Delfi Personalized Tourniquet System), Other: Standard rehabilitationThe blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine. |
| Standard rehabilitation | Sham comparator | Other: Standard rehabilitationThe standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants who undergo surgery for arthroscopic meniscus repair
Key exclusion criteria (2 listed)
- Participants undergoing surgery for concomitant ligamentous surgeries
- Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity
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 (Delfi Personalized Tourniquet System)Also: Delfi Personalized Tourniquet SystemThe Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol. | Device | Blood flow restriction |
| Standard rehabilitationPost-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair. | Other | Blood flow restriction, Standard rehabilitation |
Primary outcome
Knee Extension Force at Week 1
Time frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 2
Time frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 3
Time frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 4
Time frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 5
Time frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 6
Time frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 7
Time frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 8
Time frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 9
Time frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 10
Time frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 11
Time frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 12
Time frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Thigh Circumference at Week 1
Time frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 2
Time frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 3
Time frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 4
Time frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 5
Time frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 6
Time frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 7
Time frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 8
Time frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 9
Time frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 10
Time frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 11
Time frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 12
Time frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
9 secondary outcomes
International Knee Documentation Committee (IKDC) Score at Week 6
Time frame: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
International Knee Documentation Committee (IKDC) Score at Week 12
Time frame: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
International Knee Documentation Committee (IKDC) Score at Week 24
Time frame: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
Y-balance Testing at Week 12
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
Y-balance Testing at Week 24
Time frame: 6 months (performed at 3 months and 6 months post-operatively)
3-hop Test at Week 12
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
3-hop Test at Week 24
Time frame: 6 months (performed at 3 months and 6 months post-operatively)
Single Leg Squat Testing at Week 12
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
Single Leg Squat Testing at Week 24
Time frame: 6 months (performed at 3 months and 6 months post-operatively)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sachin Allahabadi, MD principal investigator
University of California, San Francisco
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 (Delfi Personalized Tourniquet System) and Standard rehabilitation in people with Meniscus Disorder and Meniscus, Torn Tibial, run by University of California, San Francisco 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 Feb 2026. 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. 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 20 Feb 2026). 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?
Knee Extension Force at Week 1 (time frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)). The study lists 24 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 20 Feb 2026.