The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Repair
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - 80 |
| Updated: | 2/3/2019 |
| Start Date: | April 17, 2018 |
| End Date: | April 17, 2032 |
A Prospective Cohort Clinical Trail Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-enhanced ACL Repair (BEAR)
Bridge-Enhanced ACL Repair (BEAR) is a new procedure being developed to treat patients with
ACL injuries. In the BEAR procedure, a scaffold is placed between the torn ends of the ACL
and the patient's own blood is added to the scaffold 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 of 300 patients 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.
ACL injuries. In the BEAR procedure, a scaffold is placed between the torn ends of the ACL
and the patient's own blood is added to the scaffold 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 of 300 patients 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 of 300 patients 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 study
will enroll patients both at Boston Children's Hospital as well as Rhode Island Hospital.
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 study
will enroll patients both at Boston Children's Hospital as well as Rhode Island Hospital.
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.
We found this trial at
2
sites
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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