Clinical trial NCT05398341: A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
Official title: A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL
ACL surgery
ACL tear
Torn ACL
BEAR Implant
BEAR ACL
BEAR restoration
Bridge-enhanced ACL restoration
ACL restoration
ACL implant bridge
Lead sponsor: Miach Orthopaedics
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.

Brief summary: The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for Prospective Cohort:

1. Scheduled to undergo ACL surgery with the BEAR Implant
2. Willing and able to provide informed consent
3. 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:

1. 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
2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
timeFrame: 2 Years
measure: Knee laxity based on the Lachman test at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care
timeFrame: 6-12 months
measure: 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
timeFrame: 6 months- 2 years post surgery
measure: Marx Activity Score at 6, 9, 12 months and at 2 years after surgery
timeFrame: 6 months thru 2 years
measure: Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery
timeFrame: 6 months thru 2 years
measure: VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery
timeFrame: 1 year
measure: Current Status Questionnaire
timeFrame: 2 years
measure: Pain Medication Use
timeFrame: 2 years
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford
state: California
city: Steamboat Springs
country: United States
facility: Steamboat Orthopaedic and Spine Institute
state: Colorado
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Skaneateles
country: United States
facility: Victory Sports Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
References: