Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294314
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Brief Title:
Return to Play After ACL Reconstruction With Bone Marrow Aspirate DBM and an Internal Brace
Sponsor:
Marshall University
Organization:
Marshall University
Study Overview
Official Title:
Return to Play After Anterior Cruciate Ligament Reconstruction With Bone Marrow Aspirate Demineralized Bone Matrix and an Internal Brace
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information
Detailed Description:
At the pre-operative appointment patients will be informed of the research study and have the option to participate After informed consent research subjects will provide baseline characteristics via survey from Code This will include demographics name age date of birth height weight body mass index smoking status laterality mechanism of injury sport participation and baseline PROs International Knee Documentation Form IKDC Subjective Knee Evaluation Form Knee injury and Osteoarthritis Outcome Score KOOS Global Marx Activity Scale visual analogue scores VAS pain and ACL-Return to Sport Index RSI scores Data from pre-operative physical exam will also be collected
Procedural outcomes including graft type length and tunnel size will be recorded Operative time concomitant pathologies surgical complications will also be recorded In addition costs of the procedure including surgeon fee facility fee and facility cost charges ratio will be recorded
RTS evaluation will occur at 3- 4- 5- 6- 9- and 12-months and results will determine readiness to RTP by Limb Symmetry Index LSI equal or greater than 85 in biomechanical testing see below
At 6 months all subjects will undergo magnetic resonance imaging MRI of the operative extremity to investigate bone healing between groups Imaging for this time-point is paid for by the grantsponsor there is no cost to the subject and it is NOT submitted to insurance
Primary outcomes will include results of RTS tests in FACL and control groups RTS rates and timelines after FACL reconstruction and re-injury rates within 2-years post-operatively Secondary outcomes will include radiographic outcomes bone tunnel enlargement patient-reported outcomes IKDC KOOS Global Marx activity VAS pain and ACL-RSI Complications total re-operations and revisions ACL reconstruction rates will also be recorded
Patient-reported outcomes will be measured preoperatively and at 6-weeks 3-months 45-months 6-months 9-months 12-months and 24-months postoperatively
Biomechanical Testing Video andor Virtual Reality Testing A videovirtual reality approach will track individuals movements and provide objective data that will guide decisions for both injury risk stratification and neuromuscular training to lower the risk of a non-contact musculoskeletal injury The videovirtual reality system will be Trazer andor Vicon This technology utilizes a virtual avatar that is the mirror image of the subject and will provide subject biomechanical data that will include reaction time joint angles and acceleration are variables that will be measured using this technology Four trials will be performed for each participant
Force Plate Testing Force plate technology will be utilized to assess the effects of ground reaction forces on musculoskeletal mechanics Force components of jumps hops and balancing capabilities will be assessed in these athletes This data will provide strengths and weaknesses of athletes and guide development of neuro-motor training regimens to ameliorate weaknesses Force plate technology utilized will include those from Sparta Science and AMTI Participants will be asked to balance on each leg twice and to jump on the plate 3 times Four trials will be performed for each participant
IMU Testing A third technology utilized will be inertial measurement units IMUs that subjects will wear The sensors on these devices utilize holsters or less often light adhesives on the skin These devices have built in algorithms that measure movement and provide objective muscle activation data which include athlete risk stratification variables that include ROM varusvalgus stress and anteriorposterior joint displacement IMUs utilized will include DorsaVi and Vicon Four trials will be performed for each participant
METHODS SIZE OF COHORT
The goal sample size will be 125-150 patients in the FACL group and approximately 300 patients in the control group
ENROLLMENT
Enrollment will take place at a single site where up to 450 patients will be included in the study Patients will sign the informed consent if they agree to participate in the study The anticipated screening and enrollment period will be approximately 12 to 36 months thus enrollment should be met
PROCESS OF SUBJECT ENROLLMENT AND CONSENT Eligible patient andor legal guardians electing surgery will be identified during their visit to the clinics and will be offered an opportunity to participate If a patient is deemed a candidate for the study either the investigator or the site study coordinator will discuss the study in detail During the discussion the investigatorstudy coordinator will explain the purpose of the study and will outline the studys requirements The investigatorsite coordinator will also explain that the study is voluntary that they may withdraw from research at any time and that their care will not be influenced at all should they elect not to participate in the study or withdraw from the study
After allowing ample time for questions and answers the investigator will ask the patient andor legal guardian for consent If the patient andor legal guardian gives verbal consent for participation heshe will then sign a written informed consent The investigator or designee will conduct the informed consent process in a time unlimited private atmosphere and in a manner conducive to rational and thoughtful decision making by the subject or in the case of Children the subjects legal guardian without any element of coercion or undue influence Patient andor legal guardians may take consent forms home without signing to review and consider with advisors
Procedural outcomes including graft type length and tunnel size will be recorded Operative time concomitant pathologies surgical complications will also be recorded In addition costs of the procedure including surgeon fee facility fee and facility cost charges ratio will be recorded
RTS evaluation will occur at 3- 4- 5- 6- 9- and 12-months and results will determine readiness to RTP by Limb Symmetry Index LSI equal or greater than 85 in biomechanical testing see below
At 6 months all subjects will undergo magnetic resonance imaging MRI of the operative extremity to investigate bone healing between groups Imaging for this time-point is paid for by the grantsponsor there is no cost to the subject and it is NOT submitted to insurance
Primary outcomes will include results of RTS tests in FACL and control groups RTS rates and timelines after FACL reconstruction and re-injury rates within 2-years post-operatively Secondary outcomes will include radiographic outcomes bone tunnel enlargement patient-reported outcomes IKDC KOOS Global Marx activity VAS pain and ACL-RSI Complications total re-operations and revisions ACL reconstruction rates will also be recorded
Patient-reported outcomes will be measured preoperatively and at 6-weeks 3-months 45-months 6-months 9-months 12-months and 24-months postoperatively
Biomechanical Testing Video andor Virtual Reality Testing A videovirtual reality approach will track individuals movements and provide objective data that will guide decisions for both injury risk stratification and neuromuscular training to lower the risk of a non-contact musculoskeletal injury The videovirtual reality system will be Trazer andor Vicon This technology utilizes a virtual avatar that is the mirror image of the subject and will provide subject biomechanical data that will include reaction time joint angles and acceleration are variables that will be measured using this technology Four trials will be performed for each participant
Force Plate Testing Force plate technology will be utilized to assess the effects of ground reaction forces on musculoskeletal mechanics Force components of jumps hops and balancing capabilities will be assessed in these athletes This data will provide strengths and weaknesses of athletes and guide development of neuro-motor training regimens to ameliorate weaknesses Force plate technology utilized will include those from Sparta Science and AMTI Participants will be asked to balance on each leg twice and to jump on the plate 3 times Four trials will be performed for each participant
IMU Testing A third technology utilized will be inertial measurement units IMUs that subjects will wear The sensors on these devices utilize holsters or less often light adhesives on the skin These devices have built in algorithms that measure movement and provide objective muscle activation data which include athlete risk stratification variables that include ROM varusvalgus stress and anteriorposterior joint displacement IMUs utilized will include DorsaVi and Vicon Four trials will be performed for each participant
METHODS SIZE OF COHORT
The goal sample size will be 125-150 patients in the FACL group and approximately 300 patients in the control group
ENROLLMENT
Enrollment will take place at a single site where up to 450 patients will be included in the study Patients will sign the informed consent if they agree to participate in the study The anticipated screening and enrollment period will be approximately 12 to 36 months thus enrollment should be met
PROCESS OF SUBJECT ENROLLMENT AND CONSENT Eligible patient andor legal guardians electing surgery will be identified during their visit to the clinics and will be offered an opportunity to participate If a patient is deemed a candidate for the study either the investigator or the site study coordinator will discuss the study in detail During the discussion the investigatorstudy coordinator will explain the purpose of the study and will outline the studys requirements The investigatorsite coordinator will also explain that the study is voluntary that they may withdraw from research at any time and that their care will not be influenced at all should they elect not to participate in the study or withdraw from the study
After allowing ample time for questions and answers the investigator will ask the patient andor legal guardian for consent If the patient andor legal guardian gives verbal consent for participation heshe will then sign a written informed consent The investigator or designee will conduct the informed consent process in a time unlimited private atmosphere and in a manner conducive to rational and thoughtful decision making by the subject or in the case of Children the subjects legal guardian without any element of coercion or undue influence Patient andor legal guardians may take consent forms home without signing to review and consider with advisors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None