A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

Study Overview
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Brief Summary
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The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.

Detailed Description
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This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.

Official Title
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A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Device: The BEAR® Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Prospective Cohort: Scheduled to undergo ACL surgery with the BEAR Implant Willing and able to provide informed consent Willing and able to complete required follow-up visits and assessments Inclusion Criteria for Retrospective Cohort: 1. Underwent ACL surgery with the BEAR Implant Exclusion Criteria: The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. | Device: The BEAR® Implant<br>* The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.<br>|
| Retrospective Cohort<br>A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group. | Device: The BEAR® Implant<br>* The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2 | 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. | 2 Years | 
| Knee laxity based on the Lachman test at 1 year | The Lachman will be performed during physical exam. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care | 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. | 6-12 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery | 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. | 6 months- 2 years post surgery | 
| Marx Activity Score at 6, 9, 12 months and at 2 years after surgery | Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation. | 6 months thru 2 years | 
| Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery | Measures the patients emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. There are 12 questions and the subjects answer each in range is from 0 to 100. The response scale meaning is dictated by the question. The sum of all questions are reported, divided by 12,000 and multiplied by 100 to get a %. | 6 months thru 2 years | 
| VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery | A tool widely used to measure pain. The patient indicates his/her perceived pain intensity along a 100 mm horizontal line and this rate is then measure from the left edge to give a score. | 1 year | 
| Current Status Questionnaire | Elements include return to activity, pain medication use. No Score. | 2 years | 
| Pain Medication Use | Administered by questionnaire. No score. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, ACL surgery, ACL tear, Torn ACL, BEAR Implant, BEAR ACL, BEAR restoration, Bridge-enhanced ACL restoration, ACL restoration, ACL implant bridge