Clinical Trials

Inclusion Criteria: 

• Confirmed meniscal tear by physical exam and MRI (minimum 5T).
• Recommended to undergo surgical intervention using SoftStitch™ for All-Inside meniscus repair of longitudinal tears on the posterior horn that a surgeon would traditionally repair with two or more all-inside devices, as standard of care.
• Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays.
• Male or female, ≥ 18 years old and ≤ 55.
• Provide written informed consent.
• Able and willing to participate in follow up visits and all required activities.
• Have a valid email and internet access to receive and respond to ePROs throughout the study.

Exclusion Criteria:

• Meniscal tears which are not amendable to repair, such as degenerative, flap, radial, complex, etc..
• ACL-injured knees that are unstable.
• Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax.
• Blood supply limitations and previous or active.
• Joint or systemic infections which may decrease healing.
• Skeletally immature defined as patients with open epiphyseal plates viewed on radiographs.
• Concomitant disease that would interfere with study outcomes.
• Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
• Locked knee or haemarthrosis.
• Mutiligament knee injuries requiring multiple ligament surgical stabilizatiin.
• Concomitant hybrid meniscal repair techniques or devices.
• Advanced Osteoarthritis; Kellgren Lawrence ≥ 2.
• Fracture of the lower extremities within 6 months prior to screening.
• Previous surgery on the affected knee within 12 months prior to screening.
  • Subject is included in a vulnerable population (child, prisoner, etc.).
• Subject is requesting or receiving Worker's Compensation related to the knee injury.
• Inability to reply to online questionnaires because of mental impairment.
• Planned participation in another clinical study in the next two years.

Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.