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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03348995
• Other study ID #: BEAR III Trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: April 17, 2034

Study information

• Verified date: August 2023
• Source: Miach Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: April 17, 2034
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University School Of Medicine	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	UT Southwestern	Dallas	Texas
United States	Inova Sports Medicine	Fairfax	Virginia
United States	MedStar Health Surgery Center of Timonium	Lutherville	Maryland
United States	Virtua Health	Marlton	New Jersey
United States	Ochsner Sports Medicine Institute	New Orleans	Louisiana
United States	Cynthia Chrostek	Providence	Rhode Island
United States	Scripps Health	San Diego	California
United States	Orthopedic Institute of Sioux Falls	Sioux Falls	South Dakota
United States	Florida Orthopedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miach Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Documentation Committee Subjective Score (IKDC) (Survey)	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.	Time points up to two years
Primary	International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)	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.	Time points up to two years.
Secondary	Knee Injury and Osteoarthritis Score (KOOS) questionnaire	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.	Time points up to two years
Secondary	Repair Failure	The number of times patients develop recurrent knee stability and require another ACL surgery.	Two years