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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (11)

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