Blood Flow Restriction Therapy*BFR*NCT07406763
Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT
A study testing traditional rehabilitation protocol and Blood Flow Restriction in people with Blood Flow Restriction Therapy and Anterior Cruciate Ligament (ACL), run by Ahmed Mohamed Mahmoud Abdelaziz Khalil at 2 sites in Egypt.
Trial summary
The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Blood Flow Restriction Therapy, Anterior Cruciate Ligament (ACL)
- What is being tested?
- traditional rehabilitation protocol and Blood Flow Restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2020to 1 Feb 2022
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Male or female participants aged 18-35 years Undergoing primary unilateral anterior cruciate ligament reconstruction Reconstruction performed using semitendinosus tendon autograft Referred for postoperative rehabilitation by an orthopedic surgeon Medically cleared to participate in postoperative rehabilitation and exercise training Ability to understand and follow verbal instructions Willingness to participate and provide written informed consent Exclusion Criteria History of previous surgery on either knee Concomitant ligament injuries requiring surgical repair (e.g., PCL, MCL, LCL) Severe meniscal injury requiring repair or affecting rehabilitation progression Known cardiovascular, vascular, or thromboembolic disorders Peripheral vascular disease or conditions contraindicating blood flow restriction training Neurological disorders affecting lower limb function Uncontrolled systemic disease (e.g., uncontrolled diabetes or hypertension) Postoperative complications such as infection, deep vein thrombosis, or graft failure Inability to comply with the rehabilitation program or follow-up assessments
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Cairo, Cairo Governorate, 11511
Physical Therapy
Giza, 12613
About this study
Official title: Effect of Adding Blood Flow Restriction to Traditional Program After Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR).
This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft.
Read more
The main questions it aims to answer are:
Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes.
Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
Read the detailed description
Anterior cruciate ligament reconstruction (ACLR) is commonly followed by persistent quadriceps and hamstring weakness, reduced knee range of motion, impaired proprioception, pain, and limitations in lower limb function despite standard rehabilitation. Traditional postoperative rehabilitation protocols may not fully restore neuromuscular performance within the early months following surgery.
Blood flow restriction (BFR) training has emerged as a rehabilitation strategy that allows low-load exercise to produce strength gains comparable to high-load training by partially restricting arterial inflow and venous outflow during exercise. This approach may be particularly beneficial in the early postoperative phase after ACLR, when high mechanical loading is contraindicated.
This randomized controlled clinical trial investigates the effects of adding BFR training to a traditional rehabilitation protocol following ACL reconstruction. Participants are randomly allocated to either a traditional rehabilitation protocol alone or the same protocol combined with BFR applied to the operated limb during exercise sessions. Rehabilitation is initiated in the early postoperative period and continues for a standardized duration.
Clinical outcomes related to muscle performance, knee joint function, proprioceptive accuracy, range of motion, and pain are evaluated at multiple time points before and after surgery to examine short-term and mid-term recovery patterns. The study aims to determine whether the inclusion of BFR enhances functional recovery compared with conventional rehabilitation alone following ACLR.
- Being tested
- traditional rehabilitation protocol, Blood Flow Restriction
- Keywords
- ACLR, BFRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional rehabilitation protocolOther
The traditional rehabilitation protocol includes progressive therapeutic exercises aimed at restoring:
Quadriceps and hamstring muscle strength Knee joint range of motion Neuromuscular control and functional performance
Blood Flow RestrictionDevice
Blood flow restriction was applied to the proximal thigh of the operated limb using a specially designed sphygmomanometer cuff capable of partially restricting arterial inflow and venous outflow during exercise. BFR was used during low-load resistance exercises targeting the quadriceps and hamstring muscles, in accordance with postoperative safety guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Rehabilitation Protocol Group | Active comparator | Participants in this group received a standard postoperative rehabilitation program following anterior cruciate ligament reconstruction (ACLR) from the 2nd to the 12th postoperative week. Receives: Other: traditional rehabilitation protocol |
| Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group | Experimental | Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises. Receives: Other: traditional rehabilitation protocol; Device: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Hamstring Muscle Strength
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Secondary outcomes (4)
Knee Joint Proprioception (Joint Position Sense)
Assessed using a digital inclinometer Evaluated as joint position sense accuracy
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Knee Joint Range of Motion (ROM)
Flexion and extension measured using a digital goniometer
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Knee Joint Pain
Assessed using the Visual Analog Scale (VAS)
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Lower Limb Function
Assessed using the Arabic version of the Lower Extremity Functional Scale (LEFS)
Measured: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Feb 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Blood Flow Restriction TherapyStudies 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
- Double-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Mahmoud Abdelaziz Khalil
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Mahmoud Abdelaziz Khalil, Cairo University
- Investigators
- Maha Mohammed, A.Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406763
- Sponsor's protocol ID
- P.T.REC/012/003141
- Acronym
- *BFR*
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable - the thesis does not describe a plan to share individual participant data with other researchers.
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 16339340Kramer LC, Denegar CR, Buckley WE, Hertel J. Factors associated with anterior cruciate ligament injury: history in female athletes. J Sports Med Phys Fitness. 2007 Dec;47(4):446-54.
PubMed 18091686Elwood PC, Pickering J, Bayer A, Gallacher JE. Vascular disease and cognitive function in older men in the Caerphilly cohort. Age Ageing. 2002 Jan;31(1):43-8. doi: 10.1093/ageing/31.1.43.
PubMed 11850307Yip T, Wang Y, Mootoo C, Mirpuri S. Moderating the association between discrimination and adjustment: A meta-analysis of ethnic/racial identity. Dev Psychol. 2019 Jun;55(6):1274-1298. doi: 10.1037/dev0000708. Epub 2019 Mar 25.
PubMed 30907605Pletch A, Morcuende J, Barriga H, Segura J, Salas A. Photovoice and Clubfoot: Using a Participatory Research Method to Study Caregiver Adherence to the Ponseti Method in Peru. Iowa Orthop J. 2015;35:160-8.
PubMed 26361460Lepley 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 30852644Herring AA, Stone MB, Frenkel O, Chipman A, Nagdev AD. The ultrasound-guided superficial cervical plexus block for anesthesia and analgesia in emergency care settings. Am J Emerg Med. 2012 Sep;30(7):1263-7. doi: 10.1016/j.ajem.2011.06.023. Epub 2011 Oct 24.
PubMed 22030184Laurentino GC, Loenneke JP, Mouser JG, Buckner SL, Counts BR, Dankel SJ, Jessee MB, Mattocks KT, Iared W, Tavares LD, Teixeira EL, Tricoli V. Validity of the Handheld Doppler to Determine Lower-Limb Blood Flow Restriction Pressure for Exercise Protocols. J Strength Cond Res. 2020 Sep;34(9):2693-2696. doi: 10.1519/JSC.0000000000002665.
PubMed 29912080Schlag J, Pouget A, Sadeghpour S, Schlag-Rey M. Interactions between natural and electrically evoked saccades. III. Is the nonstationarity the result of an integrator not instantaneously reset? J Neurophysiol. 1998 Feb;79(2):903-10. doi: 10.1152/jn.1998.79.2.903.
PubMed 9463451Felszeghy S, Modis L, Nemeth P, Nagy G, Zelles T, Agre P, Laurikkala J, Fejerskov O, Thesleff I, Nielsen S. Expression of aquaporin isoforms during human and mouse tooth development. Arch Oral Biol. 2004 Apr;49(4):247-57. doi: 10.1016/j.archoralbio.2003.09.011.
PubMed 15003543Krych AJ, Pitts RT, Dajani KA, Stuart MJ, Levy BA, Dahm DL. Surgical repair of meniscal tears with concomitant anterior cruciate ligament reconstruction in patients 18 years and younger. Am J Sports Med. 2010 May;38(5):976-82. doi: 10.1177/0363546509354055. Epub 2010 Mar 18.
PubMed 20299545Liu A, Xue GH, Sun M, Shao HF, Ma CY, Gao Q, Gou ZR, Yan SG, Liu YM, He Y. 3D Printing Surgical Implants at the clinic: A Experimental Study on Anterior Cruciate Ligament Reconstruction. Sci Rep. 2016 Feb 15;6:21704. doi: 10.1038/srep21704.
PubMed 26875826Lindstrom M, Strandberg S, Wredmark T, Fellander-Tsai L, Henriksson M. Functional and muscle morphometric effects of ACL reconstruction. A prospective CT study with 1 year follow-up. Scand J Med Sci Sports. 2013 Aug;23(4):431-42. doi: 10.1111/j.1600-0838.2011.01417.x. Epub 2011 Nov 23.
PubMed 22107159Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1.
PubMed 22982712Malinzak RA, Colby SM, Kirkendall DT, Yu B, Garrett WE. A comparison of knee joint motion patterns between men and women in selected athletic tasks. Clin Biomech (Bristol). 2001 Jun;16(5):438-45. doi: 10.1016/s0268-0033(01)00019-5.
PubMed 11390052
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Blood Flow Restriction to Traditional Program After Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07406763
- Acronym / sponsor ID
- *BFR* / P.T.REC/012/003141
- Keywords
- ACLR, BFRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ahmed Mohamed Mahmoud Abdelaziz KhalilUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 12 Feb 2026 (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 goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR).
This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft.
The main questions it aims to answer are:
Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes.
Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
Detailed description
Anterior cruciate ligament reconstruction (ACLR) is commonly followed by persistent quadriceps and hamstring weakness, reduced knee range of motion, impaired proprioception, pain, and limitations in lower limb function despite standard rehabilitation. Traditional postoperative rehabilitation protocols may not fully restore neuromuscular performance within the early months following surgery.
Blood flow restriction (BFR) training has emerged as a rehabilitation strategy that allows low-load exercise to produce strength gains comparable to high-load training by partially restricting arterial inflow and venous outflow during exercise. This approach may be particularly beneficial in the early postoperative phase after ACLR, when high mechanical loading is contraindicated.
This randomized controlled clinical trial investigates the effects of adding BFR training to a traditional rehabilitation protocol following ACL reconstruction. Participants are randomly allocated to either a traditional rehabilitation protocol alone or the same protocol combined with BFR applied to the operated limb during exercise sessions. Rehabilitation is initiated in the early postoperative period and continues for a standardized duration.
Clinical outcomes related to muscle performance, knee joint function, proprioceptive accuracy, range of motion, and pain are evaluated at multiple time points before and after surgery to examine short-term and mid-term recovery patterns. The study aims to determine whether the inclusion of BFR enhances functional recovery compared with conventional rehabilitation alone following ACLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Traditional Rehabilitation Protocol Group | Active comparator | Other: traditional rehabilitation protocolParticipants in this group received a standard postoperative rehabilitation program following anterior cruciate ligament reconstruction (ACLR) from the 2nd to the 12th postoperative week. |
| Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group | Experimental | Other: traditional rehabilitation protocol, Device: Blood Flow RestrictionParticipants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| traditional rehabilitation protocolThe traditional rehabilitation protocol includes progressive therapeutic exercises aimed at restoring: Quadriceps and hamstring muscle strength Knee joint range of motion Neuromuscular control and functional performance | Other | Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group, Traditional Rehabilitation Protocol Group |
| Blood Flow RestrictionBlood flow restriction was applied to the proximal thigh of the operated limb using a specially designed sphygmomanometer cuff capable of partially restricting arterial inflow and venous outflow during exercise. BFR was used during low-load resistance exercises targeting the quadriceps and hamstring muscles, in accordance with postoperative safety guidelines. | Device | Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group |
Primary outcome
Quadriceps Muscle Strength
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
Hamstring Muscle Strength
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
4 secondary outcomes
Knee Joint Proprioception (Joint Position Sense)
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Knee Joint Range of Motion (ROM)
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Knee Joint Pain
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Lower Limb Function
Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: 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.
- Results publication: PubMed 18091686Kramer LC, Denegar CR, Buckley WE, Hertel J. Factors associated with anterior cruciate ligament injury: history in female athletes. J Sports Med Phys Fitness. 2007 Dec;47(4):446-54.
- Results publication: PubMed 11850307Elwood PC, Pickering J, Bayer A, Gallacher JE. Vascular disease and cognitive function in older men in the Caerphilly cohort. Age Ageing. 2002 Jan;31(1):43-8. doi: 10.1093/ageing/31.1.43.
- Results publication: PubMed 30907605Yip T, Wang Y, Mootoo C, Mirpuri S. Moderating the association between discrimination and adjustment: A meta-analysis of ethnic/racial identity. Dev Psychol. 2019 Jun;55(6):1274-1298. doi: 10.1037/dev0000708. Epub 2019 Mar 25.
- Results publication: PubMed 26361460Pletch A, Morcuende J, Barriga H, Segura J, Salas A. Photovoice and Clubfoot: Using a Participatory Research Method to Study Caregiver Adherence to the Ponseti Method in Peru. Iowa Orthop J. 2015;35:160-8.
- Results publication: 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.
- Results publication: PubMed 22030184Herring AA, Stone MB, Frenkel O, Chipman A, Nagdev AD. The ultrasound-guided superficial cervical plexus block for anesthesia and analgesia in emergency care settings. Am J Emerg Med. 2012 Sep;30(7):1263-7. doi: 10.1016/j.ajem.2011.06.023. Epub 2011 Oct 24.
- Results publication: PubMed 29912080Laurentino GC, Loenneke JP, Mouser JG, Buckner SL, Counts BR, Dankel SJ, Jessee MB, Mattocks KT, Iared W, Tavares LD, Teixeira EL, Tricoli V. Validity of the Handheld Doppler to Determine Lower-Limb Blood Flow Restriction Pressure for Exercise Protocols. J Strength Cond Res. 2020 Sep;34(9):2693-2696. doi: 10.1519/JSC.0000000000002665.
- Results publication: PubMed 9463451Schlag J, Pouget A, Sadeghpour S, Schlag-Rey M. Interactions between natural and electrically evoked saccades. III. Is the nonstationarity the result of an integrator not instantaneously reset? J Neurophysiol. 1998 Feb;79(2):903-10. doi: 10.1152/jn.1998.79.2.903.
- Results publication: PubMed 15003543Felszeghy S, Modis L, Nemeth P, Nagy G, Zelles T, Agre P, Laurikkala J, Fejerskov O, Thesleff I, Nielsen S. Expression of aquaporin isoforms during human and mouse tooth development. Arch Oral Biol. 2004 Apr;49(4):247-57. doi: 10.1016/j.archoralbio.2003.09.011.
- Results publication: PubMed 20299545Krych AJ, Pitts RT, Dajani KA, Stuart MJ, Levy BA, Dahm DL. Surgical repair of meniscal tears with concomitant anterior cruciate ligament reconstruction in patients 18 years and younger. Am J Sports Med. 2010 May;38(5):976-82. doi: 10.1177/0363546509354055. Epub 2010 Mar 18.
- Results publication: PubMed 26875826Liu A, Xue GH, Sun M, Shao HF, Ma CY, Gao Q, Gou ZR, Yan SG, Liu YM, He Y. 3D Printing Surgical Implants at the clinic: A Experimental Study on Anterior Cruciate Ligament Reconstruction. Sci Rep. 2016 Feb 15;6:21704. doi: 10.1038/srep21704.
- After inclusion in the study, every patient signed an informed consent form , and then was randomly assigned to one of the two groups using a random generatorLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable - the thesis does not describe a plan to share individual participant data with other researchers.
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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.
Maha Mohammed, A.Prof study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional rehabilitation protocol and Blood Flow Restriction in people with Blood Flow Restriction Therapy and Anterior Cruciate Ligament (ACL), run by Ahmed Mohamed Mahmoud Abdelaziz Khalil at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 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 2 sites in Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quadriceps Muscle Strength (time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative). The study lists 2 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 NCT07406763, which also lists 25 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 12 Feb 2026.