Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge-Enhanced ACL Restoration (BEAR) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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.
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Health | San Diego | California | 92121 | United States | ||
| Florida Orthopedic Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cohort Study
Not provided
Not provided
Not provided
Not provided
| Repair Failure | The number of times patients develop recurrent knee stability and require another ACL surgery. | Two years |
| Tampa |
| Florida |
| 33637 |
| United States |
| Emory University School Of Medicine | Atlanta | Georgia | 30329 | United States |
| Ochsner Sports Medicine Institute | New Orleans | Louisiana | 70121 | United States |
| MedStar Health Surgery Center of Timonium | Lutherville | Maryland | 21093 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Cynthia Chrostek | Providence | Rhode Island | 02903 | United States |
| Orthopedic Institute of Sioux Falls | Sioux Falls | South Dakota | 57105 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Inova Sports Medicine | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided