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The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. |
| |
| Retrospective Cohort | A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The BEAR® Implant | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria for Prospective Cohort:
Inclusion Criteria for Retrospective Cohort:
1. Underwent ACL surgery with the BEAR Implant
Exclusion Criteria:
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The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Redwood City | California | 94063 | United States | ||
| Steamboat Orthopaedic and Spine Institute |
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|
| 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 |
| Steamboat Springs |
| Colorado |
| 80487 |
| United States |
| Advent Health | Orlando | Florida | 32804 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Victory Sports Medicine | Skaneateles | New York | 13152 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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