Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate cBMA as a Treatment to Modify Post-Traumatic Osteoarthritis PTOA Following Revision Anterior Cruciate Ligament Reconstruction ACLR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate cBMA in improving post traumatic osteoarthritis PTOA symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery The main questions it aims to answer are whether clinical outcomes such as pain are improved in patients who get cBMA with surgery if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects
Detailed Description:
Anterior cruciate ligament reconstruction ACLR surgery is considered a relatively safe and effective procedure however up to 18 of grafts will fail and require revision surgery Some studies have shown that these patients may be at increased risk of worse clinical outcomes including fast progression toward post-traumatic osteoarthritis PTOA This is likely in part due to the inflammatory environment created within the joint Concentrated bone marrow aspirate cBMA is a regenerative medicine therapy that contains soluble factors and connective tissue progenitor cells which may have immunomodulatory and pro-regenerative potential The use of this therapy in conjunction with standard of care surgical treatment may help reduce the inflammatory microenvironment inside the joint therefore modifying the conditions that might lead to developing long term complications such as PTOA
We hypothesize that cBMA treatment at the time of revision ACLR may improve clinical outcomes at 1 year after surgery and reduce the risk of developing PTOA-associated symptoms
Participants will be randomized to either get a cBMA injection investigational arm at the time of surgery or a placebo incision control arm Biological specimens blood urine synovial fluid imaging data functional tests and patient reported clinical outcomes will be measured at different time points during the study for up to two years after the surgery This will allow us to evaluate the effect of cBMA in clinical outcomes Biological specimens will be analyzed using molecular biology techniques to determine their composition including the concentration of cells and other inflammatory markers
We hypothesize that cBMA treatment at the time of revision ACLR may improve clinical outcomes at 1 year after surgery and reduce the risk of developing PTOA-associated symptoms
Participants will be randomized to either get a cBMA injection investigational arm at the time of surgery or a placebo incision control arm Biological specimens blood urine synovial fluid imaging data functional tests and patient reported clinical outcomes will be measured at different time points during the study for up to two years after the surgery This will allow us to evaluate the effect of cBMA in clinical outcomes Biological specimens will be analyzed using molecular biology techniques to determine their composition including the concentration of cells and other inflammatory markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1177535 | OTHER_GRANT | Arthritis Foundation | None |