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An anterior cruciate ligament (ACL) implant can be
suggested as an effective treatment option for ACL rupture.
Lately, an ACL implant, was granted marketing authorization by the FDA on 16th December 2020 as a new treatment option for ACL rupture. As opposed to the conservative reconstruction, this device does not entail the harvested tendons usage for ACL repair and is the only presently- available as a substitute to reconstruction with allograft, autograft or suture-only repair for ACL rupture treatment. This implant works by absorbing and replacing the body's own tissue in about 8 weeks following the surgical implant placement.
The marketing authorization by FDA was based on the safety and efficacy study of this implant in a total of 100 patients with complete ACL rupture. Sixty-five patients received the Implant and thirty-five patients of the control group had ACL reconstruction with autograft. The patients received physical therapy with a 2 years’ follow-up.
Based on the International Knee Documentation Committee Subjective Score questionnaire comprising of questions about symptoms like stiffness and pain, sports activity and knee function, the patients with implant had a good score than the control group patients (Table 1) at 2-year follow-up:
Based on arthrometric assessments, patients with the implant had a greater laxity by 1.7 mm in the treated knee than untreated knee at 2 years’. But in control group, it was greater by 1.8 mm in the treated knee as compared to untreated knee at 2 years’. Graft or repair failure was reported as a complication in the study.
This Implant is designated for skeletally mature patients aged at least 14 years with an extensive rupture of the ACL, as established by MRI. The patients must have an ACL stump connected to the tibia for repair construction.
FDA
FDA Authorizes Marketing of New Implant to Repair a Torn ACL
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