ACL TearFACLNCT04178538
The Effect of Fertilized ACL Technique on Outcomes of ACL Reconstruction in Young Adults
A study testing ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation and Standard ACL reconstruction with all inside technique in people with ACL Tear and ACL Injury, run by Marshall University at 1 site in United States.
Trial summary
A prospective study, with outcomes including re-rupture rate and return to sport will be collected following ACL reconstruction. In keeping with the surgeon's standard practice, patients 24 years and under that are skeletally mature, will receive a quad tendon autograft; patients 25 years of age and over will receive… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- ACL Tear, ACL Injury, Arthroscopy
- What is being tested?
- ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation and Standard ACL reconstruction with all inside technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 11 Nov 2023
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be age 14-60 years old.
- Must be skeletally mature (Tanner 4) patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft or allograft augmentation.
- Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, (and such pathology and treatment will be recorded).
- An understanding of the purpose of the study, and have signed the informed consent.
- Able to return for all subsequent study visits
Who cannot join
- Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
- Patients whom have had previous ACL reconstructive surgery on ipsilateral knee.
- Patients who are currently pregnant or nursing.
- Patients who have a current infection at the operative site.
- Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
- Workmen's compensation cases
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall University Department of Orthopedics
Huntington, West Virginia, 25701-4021
About this study
Official title: The Effect of Bone Marrow Aspirate, Demineralized Bone Matrix, and InternalBrace™ on the Outcomes of Anterior Cruciate Ligament Reconstruction in Young Adults; Failure Rates and Return to Play
A prospective study, with outcomes including re-rupture rate and return to sport will be collected following ACL reconstruction. In keeping with the surgeon's standard practice, patients 24 years and under that are skeletally mature, will receive a quad tendon autograft; patients 25 years of age and over will receive an allograft All-Inside ACL reconstruction. These two cohorts will then be randomized into two groups, one with bone marrow/DBM and InternalBrace augmentation, and one without. The study procedures will involve use of x-rays, MRI, CT scan, and surveys at varying time points to assess radiographic, imaging and clinical outcomes.
Read the detailed description
Graft re-rupture is one of the major complications and causes of reoperation after anterior cruciate ligament (ACL) reconstruction. This is more common in younger athletes. Based on the recent literature the rate of graft re-rupture is about 6-11%. Even with newer techniques and different types of grafts the re-rupture rates and return to play have not improved significantly. Athletes younger than 25 years old have been found to have a 23% risk of secondary ACL injury either on the contralateral or ipsilateral side after an ACL reconstruction. Therefore, there is a direct need to improve the outcomes of ACL reconstruction especially in younger athletes. This could be accomplished with earlier biologic incorporation of the graft and further protecting the graft during the early postoperative period. Quad tendon all-inside reconstruction is a reproducible technique for younger athletes receiving surgery. For patients over the age of 22, allograft is commonly used. Recently autogenous bone marrow aspirate has shown superior radiographic incorporation when used for osteochondral allograft transplantation in the knee. The bone marrow aspirate has also shown the presence of similar mesenchymal stem cell concentrations when harvested from the proximal tibia compared to when harvested from the iliac crest; providing a useful and safe alternative during knee surgery. This bone marrow aspirate can be combined with demineralized bone matrix (DBM) as a medium for incorporation into a femoral and tibial tunnel during reconstruction of an ACL. Recently, as an augment to the procedure, an ultrahigh-molecular-weight polyethylene/polyester suture tape was used as an InternalBrace for an ACL allograft reconstruction and found to be safe and effective. The hypothesis of this study is that the combination of the InternalBrace and biologic addition of autogenous bone marrow aspirate may provide improved functional outcomes, and reduced failure rates after ACL reconstruction.
- Conditions
- ACL Tear, ACL Injury, Arthroscopy, Anterior Cruciate Ligament Tear
- Being tested
- ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation, Standard ACL reconstruction with all inside technique
- Keywords
- Anterior cruciate ligament tear, ACL
- 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.
ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentationProcedure or surgery
ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique
Standard ACL reconstruction with all inside techniqueProcedure or surgery
Standard ACL reconstruction with all inside technique
| Study group | Role | What they receive |
|---|---|---|
| 25 years and older- ACL recon with DBM, Internal brace | Experimental | Patients in this arm will be 25 years of age and over and receive ACL reconstruction augmented with demineralized bone matrix, bone marrow, and internal brace Receives: Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation |
| 25 years and older- Standard ACL reconstruction | Active comparator | Patients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction Receives: Procedure: Standard ACL reconstruction with all inside technique |
| 24 years and younger- ACL recon with DBM, Internal brace | Experimental | In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft augmented with demineralized bone matrix, bone marrow, and internal brace Receives: Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation |
| 24 years and younger- Standard ACL reconstruction | Active comparator | In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft standard all inside technique Receives: Procedure: Standard ACL reconstruction with all inside technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in X rays
AP and lateral radiographs of all patients included in the study will be obtained and assessed for changes over the study duration at specified time periods
Measured: 6 months, 1 year, and 2 years
Changes in International Knee Documentation score
Measures 3 categories: symptoms, sports activity, and knee function with a sum total 0-100 with 100 score having highest functional state and 0 low functioning.
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
Changes in Visual analog pain scale
High score 10 means high pain, low score 1 means low pain
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores
five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Measured: 6 months, 1 and 2 years post-operatively
Change in THE VETERANS RAND 12 ITEM HEALTH SURVEY
patient-reported global health measure that is used to assess a patient's overall perspective of their health. seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents physical and psychological health status. results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points.
Measured: 6 months, 1 and 2 years post-operatively
Change in LYSHOLM KNEE QUESTIONNAIRE
patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 6 months, 1 and 2 years post-operatively
Change in MARX ACTIVITY SCALE FORM
MARX focuses on four activity points: running, deceleration, cutting (changing directions while running), and pivoting. Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: 6 months, 1 and 2 years post-operatively
Return to play
We will assess the time it takes from date of ACl reconstruction until the patient returs to sporting activiy
Measured: Until study completion, average of 1 year
graft re-rupture rate
We will assess patients for incidence of graft rerupture rate during rehab or after return to play
Measured: Until study completion, average of 1 year
MRI
MIR scans will be performed first 6 patients in each group will receive MRIs of the knee to visualize graft maturation.
Measured: 12 weeks post op
CT scan of operative knee
At six (6) months, the first 6 patients in each group will receive CT scans of the knee to assess tunnel widening
Measured: 6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Dec 2019
- Primary completion11 Nov 2023 (estimated)
- Study completion11 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Chad Lavender, MD, Principal investigator, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178538
- Sponsor's protocol ID
- 1455859
- Acronym
- FACL
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29.
PubMed 23820260Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.
PubMed 26772611Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
PubMed 28224069Narbona-Carceles J, Vaquero J, Suarez-Sancho S, Forriol F, Fernandez-Santos ME. Bone marrow mesenchymal stem cell aspirates from alternative sources: is the knee as good as the iliac crest? Injury. 2014 Oct;45 Suppl 4:S42-7. doi: 10.1016/S0020-1383(14)70009-9.
PubMed 25384474Oladeji LO, Stannard JP, Cook CR, Kfuri M, Crist BD, Smith MJ, Cook JL. Effects of Autogenous Bone Marrow Aspirate Concentrate on Radiographic Integration of Femoral Condylar Osteochondral Allografts. Am J Sports Med. 2017 Oct;45(12):2797-2803. doi: 10.1177/0363546517715725. Epub 2017 Jul 24.
PubMed 28737949Lavender CD, Schaver AL, Taylor S, Peluso R, Berdis G, Singh V, Cipriani K, Lycans D, Jasko J, Hewett TE. Anterior Cruciate Ligament Reconstruction Augmentation With Bone Marrow Aspirate Concentrate, Demineralized Bone Matrix, and Suture Tape Shows No Difference in Outcomes-But Faster Functional Recovery-Versus Non-augmented Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2025 May;41(5):1496-1508. doi: 10.1016/j.arthro.2024.06.042. Epub 2024 Jul 22.
PubMed 39047990
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bone Marrow Aspirate, Demineralized Bone Matrix, and InternalBrace™ on the Outcomes of Anterior Cruciate Ligament Reconstruction in Young Adults; Failure Rates and Return to Play
- ClinicalTrials.gov ID
- NCT04178538
- Acronym / sponsor ID
- FACL / 1455859
- Conditions
- ACL Tear, ACL Injury, Arthroscopy, Anterior Cruciate Ligament Tear
- Keywords
- Anterior cruciate ligament tear, ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 11 Nov 2023 (estimated)
- Study completion
- 11 Nov 2023 (estimated)
- First posted
- 26 Nov 2019 (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.
A prospective study, with outcomes including re-rupture rate and return to sport will be collected following ACL reconstruction. In keeping with the surgeon's standard practice, patients 24 years and under that are skeletally mature, will receive a quad tendon autograft; patients 25 years of age and over will receive an allograft All-Inside ACL reconstruction. These two cohorts will then be randomized into two groups, one with bone marrow/DBM and InternalBrace augmentation, and one without. The study procedures will involve use of x-rays, MRI, CT scan, and surveys at varying time points to assess radiographic, imaging and clinical outcomes.
Detailed description
Graft re-rupture is one of the major complications and causes of reoperation after anterior cruciate ligament (ACL) reconstruction. This is more common in younger athletes. Based on the recent literature the rate of graft re-rupture is about 6-11%. Even with newer techniques and different types of grafts the re-rupture rates and return to play have not improved significantly. Athletes younger than 25 years old have been found to have a 23% risk of secondary ACL injury either on the contralateral or ipsilateral side after an ACL reconstruction. Therefore, there is a direct need to improve the outcomes of ACL reconstruction especially in younger athletes. This could be accomplished with earlier biologic incorporation of the graft and further protecting the graft during the early postoperative period. Quad tendon all-inside reconstruction is a reproducible technique for younger athletes receiving surgery. For patients over the age of 22, allograft is commonly used. Recently autogenous bone marrow aspirate has shown superior radiographic incorporation when used for osteochondral allograft transplantation in the knee. The bone marrow aspirate has also shown the presence of similar mesenchymal stem cell concentrations when harvested from the proximal tibia compared to when harvested from the iliac crest; providing a useful and safe alternative during knee surgery. This bone marrow aspirate can be combined with demineralized bone matrix (DBM) as a medium for incorporation into a femoral and tibial tunnel during reconstruction of an ACL. Recently, as an augment to the procedure, an ultrahigh-molecular-weight polyethylene/polyester suture tape was used as an InternalBrace for an ACL allograft reconstruction and found to be safe and effective. The hypothesis of this study is that the combination of the InternalBrace and biologic addition of autogenous bone marrow aspirate may provide improved functional outcomes, and reduced failure rates after ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25 years and older- ACL recon with DBM, Internal brace | Experimental | Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentationPatients in this arm will be 25 years of age and over and receive ACL reconstruction augmented with demineralized bone matrix, bone marrow, and internal brace |
| 25 years and older- Standard ACL reconstruction | Active comparator | Procedure: Standard ACL reconstruction with all inside techniquePatients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction |
| 24 years and younger- ACL recon with DBM, Internal brace | Experimental | Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentationIn this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft augmented with demineralized bone matrix, bone marrow, and internal brace |
| 24 years and younger- Standard ACL reconstruction | Active comparator | Procedure: Standard ACL reconstruction with all inside techniqueIn this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft standard all inside technique |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients must be age 14-60 years old.
- Must be skeletally mature (Tanner 4) patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft or allograft augmentation.
- Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, (and such pathology and treatment will be recorded).
- An understanding of the purpose of the study, and have signed the informed consent.
- Able to return for all subsequent study visits
Key exclusion criteria (6 listed)
- Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
- Patients whom have had previous ACL reconstructive surgery on ipsilateral knee.
- Patients who are currently pregnant or nursing.
- Patients who have a current infection at the operative site.
- Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
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 |
|---|---|---|
| ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentationACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique | Procedure or surgery | 24 years and younger- ACL recon with DBM, Internal brace, 25 years and older- ACL recon with DBM, Internal brace |
| Standard ACL reconstruction with all inside techniqueStandard ACL reconstruction with all inside technique | Procedure or surgery | 24 years and younger- Standard ACL reconstruction, 25 years and older- Standard ACL reconstruction |
Primary outcome
Changes in X rays
Time frame: 6 months, 1 year, and 2 years
AP and lateral radiographs of all patients included in the study will be obtained and assessed for changes over the study duration at specified time periods
Changes in International Knee Documentation score
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
Measures 3 categories: symptoms, sports activity, and knee function with a sum total 0-100 with 100 score having highest functional state and 0 low functioning.
Changes in Visual analog pain scale
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively
High score 10 means high pain, low score 1 means low pain
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores
Time frame: 6 months, 1 and 2 years post-operatively
five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Change in THE VETERANS RAND 12 ITEM HEALTH SURVEY
Time frame: 6 months, 1 and 2 years post-operatively
patient-reported global health measure that is used to assess a patient's overall perspective of their health. seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents physical and psychological health status. results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points.
Change in LYSHOLM KNEE QUESTIONNAIRE
Time frame: 6 months, 1 and 2 years post-operatively
patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Change in MARX ACTIVITY SCALE FORM
Time frame: 6 months, 1 and 2 years post-operatively
MARX focuses on four activity points: running, deceleration, cutting (changing directions while running), and pivoting. Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.
Return to play
Time frame: Until study completion, average of 1 year
We will assess the time it takes from date of ACl reconstruction until the patient returs to sporting activiy
graft re-rupture rate
Time frame: Until study completion, average of 1 year
We will assess patients for incidence of graft rerupture rate during rehab or after return to play
MRI
Time frame: 12 weeks post op
MIR scans will be performed first 6 patients in each group will receive MRIs of the knee to visualize graft maturation.
CT scan of operative knee
Time frame: 6 months post op
At six (6) months, the first 6 patients in each group will receive CT scans of the knee to assess tunnel widening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 23820260Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29.
- Background: PubMed 26772611Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.
- Background: PubMed 28224069Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
- Background: PubMed 25384474Narbona-Carceles J, Vaquero J, Suarez-Sancho S, Forriol F, Fernandez-Santos ME. Bone marrow mesenchymal stem cell aspirates from alternative sources: is the knee as good as the iliac crest? Injury. 2014 Oct;45 Suppl 4:S42-7. doi: 10.1016/S0020-1383(14)70009-9.
- Background: PubMed 28737949Oladeji LO, Stannard JP, Cook CR, Kfuri M, Crist BD, Smith MJ, Cook JL. Effects of Autogenous Bone Marrow Aspirate Concentrate on Radiographic Integration of Femoral Condylar Osteochondral Allografts. Am J Sports Med. 2017 Oct;45(12):2797-2803. doi: 10.1177/0363546517715725. Epub 2017 Jul 24.
- Derived from this study: PubMed 39047990Lavender CD, Schaver AL, Taylor S, Peluso R, Berdis G, Singh V, Cipriani K, Lycans D, Jasko J, Hewett TE. Anterior Cruciate Ligament Reconstruction Augmentation With Bone Marrow Aspirate Concentrate, Demineralized Bone Matrix, and Suture Tape Shows No Difference in Outcomes-But Faster Functional Recovery-Versus Non-augmented Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2025 May;41(5):1496-1508. doi: 10.1016/j.arthro.2024.06.042. Epub 2024 Jul 22.
- 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.
Chad Lavender, MD principal investigator
Marshall University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation and Standard ACL reconstruction with all inside technique in people with ACL Tear and ACL Injury, run by Marshall University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Apr 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?
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?
Changes in X rays (time frame: 6 months, 1 year, and 2 years). The study lists 11 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 NCT04178538, which also lists 6 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 5 Apr 2022.