ACL TearACLBONENCT04682392
ACL Bone Health and Loading Study
A study testing Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group and Standard ACL rehab in people with ACL Tear, run by Candice Dunkin, MS, LAT, ATC at 1 site in United States.
Trial summary
The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health. Hypothesis: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group and Standard ACL rehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Athletes undergoing ACL reconstruction with or without meniscal pathology
- MRI confirming ACL tear
- Athletes ages 16-22
Who cannot join
- Any Cognitively impaired athletes
- Athletes not in age range of 16-22
- Athletes who have additional ligament repair or chondral repair.
- Athletes with any weight bearing restrictions greater than 4 weeks.
- Athletes with re-tears or history of contralateral ACL tears
- Athletes with any systemic neuromuscular or balance disorders will not be allowed
Show all 10Show fewer
- Athletes who do not or are unable to provide consent or assent (with Parental consent).
- Pregnant women will be excluded.
- Athlete who has previously used Blood Flow Restriction
- Athletes who are unable or unwilling to complete all rehabilitation with Parkview Athletic Rehab at SportONE Parkview Fieldhouse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bone Health on Landing Mechanics on Patients Post ACL Reconstruction.
The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health.
Hypothesis: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group.
Read the detailed description
Group 1 - ACL without BFR : 30 athletes with ACL tears and will NOT do blood flow restriction (BFR). Random group allocation will be determined using envelopes for allocation concealment. The control group will be tested with a Dexascan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. They will be then Scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The scans will be completed on a normally scheduled rehabilitation session at the convenience of the radiology techs availability. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment period, and then for landing symmetry every 4 weeks after that until 28 weeks.
Group 2 - ACL with BFR: 30 athletes with ACL tear that will receive BFR. This group will be selected in the same manner as the control group. They will be tested with a dexasan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. At the initial dexascan they will also be instructed in Blood flow restriction and do exercises with blood flow restriction to prepare for initial post-surgical visit. They will be then scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment and then for landing symmetry every 4 weeks after that until 28 weeks.
The standard of care following ACL tear does not include Dexascan, force plate measurements, or blood flow restriction.
Independent Variable
- Blood Flow Restrictions (BFR) Dependent Variable
- Landing mechanics / force distribution
- Bone Mineral Density /Bone mass
- Lean Muscle Mass (LM)
- Pain via Visual Analogue Scale (VAS)
- Quad Strength using microFET®2 Digital Handheld Dynamometer
- Hamstring strength using microFET®2 Digital Handheld Dynamometer
- SL Hop Distance
- Triple Hop Distance
- Crossover hop Distance
- Keiser leg press max power at 5 reps at body weight
Procedures: Once a participant has been identified as meeting the inclusion criteria with a positive MRI finding and have agreed to schedule surgery, they will be allocated to either the control or experimental group. Random group allocation will be determined using envelopes for allocation concealment. Prior to initiation of the study, a research assistant not involved in data collection will use a random number generator to create the randomization sequence allocating an equal number of participants to each of the 2 groups, the control non BFR group and the experimental BFR group. The randomization will be concealed by having the group assignment placed inside a sealed opaque envelope within potential participant folders. This process will be documented and signed by the randomizer. Once selected and enrolled, the group assignment will be revealed and will not be blinded to either the participant or the researchers. The pre-op therapy session will be completed 48-72 hours following MRI confirmation of ACL tear if they have opted for surgical intervention. The initial post-op therapy session will be completed within 24-48 hours of surgery.
All participants will undergo bone mineral density (BMD), bone mass, and lean muscle mass (LM) measurements using Dexascan at pre-op visit, and again at initial post op visit ad then every 4 weeks from week 4-16.
Participants will also complete a total of 9 landing/jumping trials as part of testing, with rest as needed. Following the warm-up, subjects will complete 3 drop landings, 3 drop vertical jumps, and 3 countermovement jumps. The participant must demonstrate safe landing mechanics on the drop landings as determined by testing PT in order to attempt the drop vertical jumps and the countermovement jumps.
Landing assessment will be collected at initial landing session at weeks 8, 12,16,20, 24, and 28 weeks post op.
The exercises selection and progression will be standardized for BFR intervention across all subjects. The BFR group will exercise with 80% arterial limb occlusion using the Delphi automated tourniquet around the proximal thigh outfitted with Doppler (Delfi®). If 80% arterial limb occlusion is not tolerated by the participant, the pressure will be decreased to tolerance. However, the pressure will not be lowered below 60% as there is a floor effect at 60% LOP where BFR is no longer beneficial.
Exercises will be performed for 4 sets of 30-15-15-15 repetitions separated by 30s of rest and 1 BFR exercise will be performed. SL hop, Triple hop, Crossover hop, and Keiser leg press power will be measured at 12, 16, 20 and 24 weeks. Strength testing will be done with microFET®2 Digital Handheld Dynamometer every 2 weeks of the rehab process in accordance with standard rehab protocol.
- Conditions
- ACL Tear
- Being tested
- Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group, Standard ACL rehab
- Keywords
- 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.
Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction GroupDevice
Also called A Dephi Personal Tourniquet System will be utilized for the experimental group.
A Delphi Personal Tourniquet system for blood flow restriction (BFR) therapy will be applied to each treatment session for this group. They will do 3-5 exercises with the BFR system on the surgical or both lower extremities for bilateral or unilateral movements.
Standard ACL rehabOther
Standard accelerated ACL protocol
| Study group | Role | What they receive |
|---|---|---|
| Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group | Active comparator | This group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab. Receives: Device: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group; Other: Standard ACL rehab |
| Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group | Active comparator | Standard post operative ACL rehab without Blood flow restriction Receives: Other: Standard ACL rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Weight distribution landing on force plates
Athlete landing on force plates from and 18 inch height to compare loading / weight symmetry
Measured: week 28 post surgery
Secondary outcomes (1)
Bone mineral density
Bone mineral density of distal femur and proximal tibia
Measured: Week 28 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start17 Feb 2021
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: All staff participating in the study no longer employed by organization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for 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
- 2 groups with Randomized group assignments
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candice Dunkin, MS, LAT, ATC
- Sponsor type
- University, hospital or other
- Collaborators
- Parkview Health
- Responsible party
- Sponsor-investigator, Candice Dunkin, MS, LAT, ATC, Parkview Health
- Investigators
- Candice Dunkin, MAT, Principal investigator, Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682392
- Sponsor's protocol ID
- PAR20-0625-ACL-bonehealth
- Acronym
- ACLBONE
- Status last verified
- May 2026
- First submitted
- 8 Dec 2020
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nyland J, Fisher B, Brand E, Krupp R, Caborn DN. Osseous deficits after anterior cruciate ligament injury and reconstruction: a systematic literature review with suggestions to improve osseous homeostasis. Arthroscopy. 2010 Sep;26(9):1248-57. doi: 10.1016/j.arthro.2010.03.017.
PubMed 20810081Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
PubMed 25683732Lepley AS, Grooms DR, Burland JP, Davi SM, Kinsella-Shaw JM, Lepley LK. Quadriceps muscle function following anterior cruciate ligament reconstruction: systemic differences in neural and morphological characteristics. Exp Brain Res. 2019 May;237(5):1267-1278. doi: 10.1007/s00221-019-05499-x. Epub 2019 Mar 9.
PubMed 30852644Kuenze CM, Foot N, Saliba SA, Hart JM. Drop-Landing Performance and Knee-Extension Strength After Anterior Cruciate Ligament Reconstruction. J Athl Train. 2015 Jun;50(6):596-602. doi: 10.4085/1062-6050-50.2.11. Epub 2015 May 15.
PubMed 25978101Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177/2325967120906822. eCollection 2020 Mar.
PubMed 32232065Centner C, Ritzmann R, Schur S, Gollhofer A, Konig D. Blood flow restriction increases myoelectric activity and metabolic accumulation during whole-body vibration. Eur J Appl Physiol. 2019 Jun;119(6):1439-1449. doi: 10.1007/s00421-019-04134-5. Epub 2019 Apr 4.
PubMed 30949807Lauver JD, Cayot TE, Rotarius T, Scheuermann BW. The effect of eccentric exercise with blood flow restriction on neuromuscular activation, microvascular oxygenation, and the repeated bout effect. Eur J Appl Physiol. 2017 May;117(5):1005-1015. doi: 10.1007/s00421-017-3589-x. Epub 2017 Mar 21.
PubMed 28324168Lauver JD, Cayot TE, Rotarius TR, Scheuermann BW. Acute Neuromuscular and Microvascular Responses to Concentric and Eccentric Exercises With Blood Flow Restriction. J Strength Cond Res. 2020 Oct;34(10):2725-2733. doi: 10.1519/JSC.0000000000003372.
PubMed 315247809. Lambert B, Hedt CA, Jack RA, et al. Blood Flow Restriction Therapy Preserves Whole Limb Bone and Muscle Following ACL Reconstruction. Orthop J Sport Med. 2019;7(3_suppl2):2325967119S0019. doi:10.1177/2325967119S00196
10. Brandner CR, May AK, Clarkson MJ, Warmington SA. Reported side-effects and safety considerations for the use of blood flow restriction during exercise in practice and research. Tech Orthop. 2018;33(2):114-121. doi:10.1097/BTO.0000000000000259
Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
PubMed 31156448Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
PubMed 21410544Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018.
PubMed 30246795Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.
PubMed 27749358Curran MT, Bedi A, Mendias CL, Wojtys EM, Kujawa MV, Palmieri-Smith RM. Blood Flow Restriction Training Applied With High-Intensity Exercise Does Not Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(4):825-837. doi: 10.1177/0363546520904008.
PubMed 32167837
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bone Health on Landing Mechanics on Patients Post ACL Reconstruction.
- ClinicalTrials.gov ID
- NCT04682392
- Acronym / sponsor ID
- ACLBONE / PAR20-0625-ACL-bonehealth
- Conditions
- ACL Tear
- Keywords
- Blood Flow Restriction (BFR)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All staff participating in the study no longer employed by organization.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Candice Dunkin, MS, LAT, ATCUniversity, hospital or other
- Collaborators
- Parkview Health
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health.
Hypothesis: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group.
Detailed description
Group 1 - ACL without BFR : 30 athletes with ACL tears and will NOT do blood flow restriction (BFR). Random group allocation will be determined using envelopes for allocation concealment. The control group will be tested with a Dexascan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. They will be then Scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The scans will be completed on a normally scheduled rehabilitation session at the convenience of the radiology techs availability. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment period, and then for landing symmetry every 4 weeks after that until 28 weeks.
Group 2 - ACL with BFR: 30 athletes with ACL tear that will receive BFR. This group will be selected in the same manner as the control group. They will be tested with a dexasan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. At the initial dexascan they will also be instructed in Blood flow restriction and do exercises with blood flow restriction to prepare for initial post-surgical visit. They will be then scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment and then for landing symmetry every 4 weeks after that until 28 weeks.
The standard of care following ACL tear does not include Dexascan, force plate measurements, or blood flow restriction.
Independent Variable
- Blood Flow Restrictions (BFR) Dependent Variable
- Landing mechanics / force distribution
- Bone Mineral Density /Bone mass
- Lean Muscle Mass (LM)
- Pain via Visual Analogue Scale (VAS)
- Quad Strength using microFET®2 Digital Handheld Dynamometer
- Hamstring strength using microFET®2 Digital Handheld Dynamometer
- SL Hop Distance
- Triple Hop Distance
- Crossover hop Distance
- Keiser leg press max power at 5 reps at body weight
Procedures: Once a participant has been identified as meeting the inclusion criteria with a positive MRI finding and have agreed to schedule surgery, they will be allocated to either the control or experimental group. Random group allocation will be determined using envelopes for allocation concealment. Prior to initiation of the study, a research assistant not involved in data collection will use a random number generator to create the randomization sequence allocating an equal number of participants to each of the 2 groups, the control non BFR group and the experimental BFR group. The randomization will be concealed by having the group assignment placed inside a sealed opaque envelope within potential participant folders. This process will be documented and signed by the randomizer. Once selected and enrolled, the group assignment will be revealed and will not be blinded to either the participant or the researchers. The pre-op therapy session will be completed 48-72 hours following MRI confirmation of ACL tear if they have opted for surgical intervention. The initial post-op therapy session will be completed within 24-48 hours of surgery.
All participants will undergo bone mineral density (BMD), bone mass, and lean muscle mass (LM) measurements using Dexascan at pre-op visit, and again at initial post op visit ad then every 4 weeks from week 4-16.
Participants will also complete a total of 9 landing/jumping trials as part of testing, with rest as needed. Following the warm-up, subjects will complete 3 drop landings, 3 drop vertical jumps, and 3 countermovement jumps. The participant must demonstrate safe landing mechanics on the drop landings as determined by testing PT in order to attempt the drop vertical jumps and the countermovement jumps.
Landing assessment will be collected at initial landing session at weeks 8, 12,16,20, 24, and 28 weeks post op.
The exercises selection and progression will be standardized for BFR intervention across all subjects. The BFR group will exercise with 80% arterial limb occlusion using the Delphi automated tourniquet around the proximal thigh outfitted with Doppler (Delfi®). If 80% arterial limb occlusion is not tolerated by the participant, the pressure will be decreased to tolerance. However, the pressure will not be lowered below 60% as there is a floor effect at 60% LOP where BFR is no longer beneficial.
Exercises will be performed for 4 sets of 30-15-15-15 repetitions separated by 30s of rest and 1 BFR exercise will be performed. SL hop, Triple hop, Crossover hop, and Keiser leg press power will be measured at 12, 16, 20 and 24 weeks. Strength testing will be done with microFET®2 Digital Handheld Dynamometer every 2 weeks of the rehab process in accordance with standard rehab protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups with Randomized group assignments
| Arm | Type | Receives |
|---|---|---|
| Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group | Active comparator | Device: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group, Other: Standard ACL rehabThis group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab. |
| Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group | Active comparator | Other: Standard ACL rehabStandard post operative ACL rehab without Blood flow restriction |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Athletes undergoing ACL reconstruction with or without meniscal pathology
- MRI confirming ACL tear
- Athletes ages 16-22
Key exclusion criteria (10 listed)
- Any Cognitively impaired athletes
- Athletes not in age range of 16-22
- Athletes who have additional ligament repair or chondral repair.
- Athletes with any weight bearing restrictions greater than 4 weeks.
- Athletes with re-tears or history of contralateral ACL tears
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 |
|---|---|---|
| Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction GroupAlso: A Dephi Personal Tourniquet System will be utilized for the experimental group.A Delphi Personal Tourniquet system for blood flow restriction (BFR) therapy will be applied to each treatment session for this group. They will do 3-5 exercises with the BFR system on the surgical or both lower extremities for bilateral or unilateral movements. | Device | Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group |
| Standard ACL rehabStandard accelerated ACL protocol | Other | Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group, Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group |
Primary outcome
Leg Weight distribution landing on force plates
Time frame: week 28 post surgery
Athlete landing on force plates from and 18 inch height to compare loading / weight symmetry
1 secondary outcome
Bone mineral density
Time frame: Week 28 post surgery
Results and safety
The study was stopped early (reason given: All staff participating in the study no longer employed by organization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 20810081Nyland J, Fisher B, Brand E, Krupp R, Caborn DN. Osseous deficits after anterior cruciate ligament injury and reconstruction: a systematic literature review with suggestions to improve osseous homeostasis. Arthroscopy. 2010 Sep;26(9):1248-57. doi: 10.1016/j.arthro.2010.03.017.
- Background: PubMed 25683732Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
- Background: PubMed 30852644Lepley AS, Grooms DR, Burland JP, Davi SM, Kinsella-Shaw JM, Lepley LK. Quadriceps muscle function following anterior cruciate ligament reconstruction: systemic differences in neural and morphological characteristics. Exp Brain Res. 2019 May;237(5):1267-1278. doi: 10.1007/s00221-019-05499-x. Epub 2019 Mar 9.
- Background: PubMed 25978101Kuenze CM, Foot N, Saliba SA, Hart JM. Drop-Landing Performance and Knee-Extension Strength After Anterior Cruciate Ligament Reconstruction. J Athl Train. 2015 Jun;50(6):596-602. doi: 10.4085/1062-6050-50.2.11. Epub 2015 May 15.
- Background: PubMed 32232065Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177/2325967120906822. eCollection 2020 Mar.
- Background: PubMed 30949807Centner C, Ritzmann R, Schur S, Gollhofer A, Konig D. Blood flow restriction increases myoelectric activity and metabolic accumulation during whole-body vibration. Eur J Appl Physiol. 2019 Jun;119(6):1439-1449. doi: 10.1007/s00421-019-04134-5. Epub 2019 Apr 4.
- Background: PubMed 28324168Lauver JD, Cayot TE, Rotarius T, Scheuermann BW. The effect of eccentric exercise with blood flow restriction on neuromuscular activation, microvascular oxygenation, and the repeated bout effect. Eur J Appl Physiol. 2017 May;117(5):1005-1015. doi: 10.1007/s00421-017-3589-x. Epub 2017 Mar 21.
- Background: PubMed 31524780Lauver JD, Cayot TE, Rotarius TR, Scheuermann BW. Acute Neuromuscular and Microvascular Responses to Concentric and Eccentric Exercises With Blood Flow Restriction. J Strength Cond Res. 2020 Oct;34(10):2725-2733. doi: 10.1519/JSC.0000000000003372.
- Background9. Lambert B, Hedt CA, Jack RA, et al. Blood Flow Restriction Therapy Preserves Whole Limb Bone and Muscle Following ACL Reconstruction. Orthop J Sport Med. 2019;7(3_suppl2):2325967119S0019. doi:10.1177/2325967119S00196
- Background10. Brandner CR, May AK, Clarkson MJ, Warmington SA. Reported side-effects and safety considerations for the use of blood flow restriction during exercise in practice and research. Tech Orthop. 2018;33(2):114-121. doi:10.1097/BTO.0000000000000259
- Background: PubMed 31156448Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
- Background: PubMed 21410544Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
- Individual participant dataSharing planned: No
Related trials for ACL Tear
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
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.
Candice Dunkin, MAT principal investigator
Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group and Standard ACL rehab in people with ACL Tear, run by Candice Dunkin, MS, LAT, ATC 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 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: stopped early, as of the sponsor's last update on 14 May 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. 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?
The study was stopped early (reason given: All staff participating in the study no longer employed by organization.). Results are not available in the source record.
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?
Leg Weight distribution landing on force plates (time frame: week 28 post surgery). 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 NCT04682392, which also lists 17 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 14 May 2026.