SoftStitch™ Comparative Analysis of Patient Reported Outcome Measures for All-Inside Meniscal Repair


About this study

The purpose of this study is to evaluate the effectiveness of SoftStitch™ for All-Inside Meniscal Repair of longitudinal tears on the posterior horn, and to observe improvement for ePROM and functional assessments of the knee at 24 months follow-up when compared to baseline.

The secondary objective is to assess complications related to SoftStitch™, retears and repeated surgery. Structural healing of the meniscus will be evaluated at 6 months with MRI. Also, the safety profile of SoftStitch™ for All-Inside Meniscal Repair will be observed.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Daniel Saris, M.D., Ph.D.

Contact us for the latest status

Contact information:

Ciara Terry

(507) 538-3562

More information


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