Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03348995

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Health, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Bridge-Enhanced ACL Restoration (BEAR)

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Miach Orthopaedics

Industry

Registry information

Official study title

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

Important dates

Study start
2018
Primary completion
2026
Study completion
2034
First posted
Nov 21, 2017
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.