Bridge-Enhanced ACL Repair vs ACL Reconstruction
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02664545|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : February 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Tear||Device: BEAR Scaffold Procedure: Tendon Graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2028|
Experimental: Bridge-Enhanced ACL Repair (BEAR)
The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.
Device: BEAR Scaffold
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
Active Comparator: Tendon Graft
ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.
Procedure: Tendon Graft
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)
- Patient Reported Outcomes Score [ Time Frame: 2 years after surgery ]This is a survey taken by patients to report how their knee is working for them.
- Instrumented Anteroposterior (AP) laxity testing [ Time Frame: 2 years after surgery ]This is a test of how stable the knee is.
- Hamstring and Quadriceps Strength [ Time Frame: 3 months to 2 years out from surgery ]Measured by a hand-held dynamometer on both the involved and contralateral knees
- Patient Reported Outcomes Score [ Time Frame: Baseline, 6 months, 1 year and 6 and 10 years after surgery. ]This is a survey taken by patients to report how their knee is working for them
- X-ray Imaging [ Time Frame: Baseline and 2, 6 and 10 years after surgery. ]A semiflexed weight bearing MTP view, as well as a lateral projection
- MR imaging [ Time Frame: Baseline and 2, 6 and 10 years after surgery. ]MR imaging with the CISS sequence will be used to measure the volume and orientation of both the repaired knee and the contralateral knee
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): NCT02664545
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Dennis Krammer, MD||Boston Children's Hospital|