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The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

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ClinicalTrials.gov Identifier: NCT03348995
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Miach Orthopaedics

Brief Summary:
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Device: Bridge-Enhanced ACL Restoration (BEAR) Not Applicable

Detailed Description:
The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort Study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Repair Failure [ Time Frame: Two years ]
    The number of times patients develop recurrent knee stability and require another ACL surgery.



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: ACL tear, within 50 days of injury, at least 5% of the ACL attached to the tibia.

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Exclusion Criteria: Prior surgery on the affected knee, history of knee infection, use of tobacco, use of corticosteroid, chemotherapy, allergy to bovine products or gelatin, history of anaphylaxis, BMI over 35, moderate osteoarthritis.

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Information from the National Library of Medicine

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


Contacts
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Contact: Rita A Paparazzo, BS/MBA +18005906995 ext 107 clinicaltrials@miachortho.com
Contact: Beth Trainor, BSN +18005906995 ext 103 clinicaltrials@miachortho.com

Locations
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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       cchrostek@lifespan.org   
Sponsors and Collaborators
Miach Orthopaedics
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Responsible Party: Miach Orthopaedics
ClinicalTrials.gov Identifier: NCT03348995    
Other Study ID Numbers: BEAR III Trial
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries