Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
Conditions
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.
Interventions
DEVICEBridge-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.
Sponsors
Miach Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohort Study
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee Subjective Score (IKDC) (Survey) | 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 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
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Score (KOOS) questionnaire | 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 | Two years | The number of times patients develop recurrent knee stability and require another ACL surgery. |
Countries
United States
Outcome results
None listed