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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348995
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Miach Orthopaedics

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE April 17, 2018
Estimated Primary Completion Date April 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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.
  • Repair Failure [ Time Frame: Two years ]
    The number of times patients develop recurrent knee stability and require another ACL surgery.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Official Title  ICMJE A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Cohort Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Device: Bridge-Enhanced ACL Restoration (BEAR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
250
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE April 17, 2032
Estimated Primary Completion Date April 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rita A Paparazzo, BS/MBA +18005906995 ext 107 clinicaltrials@miachortho.com
Contact: Kim Mooney, BS +18005906995 clinicaltrials@miachortho.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348995
Other Study ID Numbers  ICMJE BEAR III Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Miach Orthopaedics
Study Sponsor  ICMJE Miach Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Miach Orthopaedics
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP