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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT03348995
Study type Interventional
Source Miach Orthopaedics
Contact
Status Active, not recruiting
Phase N/A
Start date April 17, 2018
Completion date April 17, 2034

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