The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03348995|
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : September 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture||Device: Bridge-Enhanced ACL Restoration (BEAR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cohort Study|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)|
|Actual Study Start Date :||April 17, 2018|
|Estimated Primary Completion Date :||April 17, 2022|
|Estimated Study Completion Date :||April 17, 2032|
Experimental: Bridge-Enhanced ACL Restoration (BEAR)
The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into
Device: Bridge-Enhanced ACL Restoration (BEAR)
In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.
- International Knee Documentation Committee Subjective Score (IKDC) (Survey) [ Time Frame: Time points up to two years ]This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
- International Knee Documentation Committee Objective Score (IKDC) (Physical Exam) [ Time Frame: Time points up to two years. ]This is an examination performed of the knee. Scores are one of four measures: A (Normal), B (Nearly Normal), C (Abnormal) and D (Severely Abnormal). A is the best outcome and D is the worst.
- Knee Injury and Osteoarthritis Score (KOOS) questionnaire [ Time Frame: Time points up to two years ]This is a survey with 5 subscales (Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee Related Quality of Life). The range of each subscale is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems. The subscales are reported individually and not combined.
- Repair Failure [ Time Frame: Two years ]The number of times patients develop recurrent knee stability and require another ACL surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348995
|Contact: Rita A Paparazzo, BS/MBA||+18005906995 ext email@example.com|
|Contact: Beth Trainor, BSN||+18005906995 ext firstname.lastname@example.org|
|United States, Maryland|
|MedStar Health Surgery Center of Timonium||Recruiting|
|Lutherville, Maryland, United States, 21093|
|Contact: Garima Arora Garima.V.Arora@medstar.net|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ryan Sanborn Ryan.Sanborn@childrens.harvard.edu|
|United States, Rhode Island|
|Cynthia Chrostek||Not yet recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Cynthia Chrostek email@example.com|