Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-26 @ 9:25 AM
Study NCT ID:
NCT03348995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Sponsor:
Miach Orthopaedics
Organization:
Study Overview
Official Title:
A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Detailed Description:
The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: