Miach Orthopaedics has treated the first participant in the BEAR III post-market study of the BEAR Implant, a medical technology to facilitate healing of torn anterior cruciate ligaments (ACL).
The bio-engineered implant secured de novo approval from the US Food and Drug Administration (FDA) in December last year.
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BEAR is indicated to be used in skeletally mature patients aged over 14 years with a complete ACL rupture as confirmed with magnetic resonance imaging (MRI).
Patients with an ACL stump attached to the tibia can get the implant to enable restoration. BEAR should be implanted within 50 days of injury and is absorbed by the body on the healing of the ACL.
The single-arm, multi-centre cohort BEAR III study will involve 250 patients who will be implanted with the BEAR device and followed for ten years.
It is intended to analyse whether age is a risk factor for a worse outcome following a bridge-enhanced ACL repair (BEAR).
The risk factor will be determined by an 11.5 point difference on the International Knee Documentation Committee (IKDC) Subjective or Objective Knee Evaluation score at two years post-surgery.
Other objectives of the trial are the impact of age on safety outcomes such as infection, graft rejection and requirement for additional surgical procedures.
A male aged 32 years with a mid-substance ACL tear was treated at MedStar Surgery Center at Timonium in Maryland, US, as the first patient in the BEAR III study.
Additional patients will be enrolled at orthopaedic centres in Maryland, Massachusetts, Louisiana, South Dakota, Georgia, Rhode Island and New Jersey.
Miach Orthopaedics president and CEO Martha Shadan said: “We have seen consistently positive results in the BEAR I and BEAR II studies.
“We’re excited to have some of the leading orthopaedic centres across the US partnering with us on BEAR III as we continue to add to our extensive base of clinical evidence for the BEAR Implant.”
