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

NCT ID: NCT05491564

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-10-01

Brief Summary

Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of SoftStitch™ when used as standard of care for All-Inside Meniscal Repair. Electronic Patient Reported Outcome Measures (ePROM), functional assessments of the knee, Adverse Events of interest and Adverse Device Effects will be assessed.

Conditions

Meniscus Tear

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

SoftStitch™

The SoftStitch™ meniscal repair system includes a unique knotless all-inside meniscal repair implant with all suture fixation, eliminating the traditional hard plastic PEEK anchors used in the previous devices.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Confirmed meniscal tear by physical exam and MRI (minimum 1.5T)

2. 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

3. Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays

4. Male or female, ≥ 18 years old and ≤55

5. Provide written informed consent

6. Able and willing to participate in follow up visits

7. Have a valid email and internet access to receive and respond to ePROs throughout the study

Exclusion Criteria

1. Meniscal tears which are not amendable to repair, such as degenerative, flap, radial, complex, etc.

2. ACL-injured knees that are unstable (concomitant ACL reconstruction OK to include)

3. Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax

4. Blood supply limitations and previous or active6, joint or systemic, infections which may decrease healing

5. Skeletally immature defined as patients with open epiphyseal plates viewed on radiographs

6. Concomitant disease that would interfere with study outcomes

7. Congenital ligamentous hypermobility defined by Beighton score 4 or 5

8. Locked knee or haemarthrosis7

9. Mutiligament injuries requiring multiligament surgical stabilization

10. Concomitant hybrid meniscal repair techniques or devices

11. Advanced Osteoarthritis; Kellgren Lawrence ≥ 2

12. Fracture of the lower extremities within 6 months prior to screening

13. Previous surgery on the affected knee within 12 months prior to screening

14. Subject is included in a vulnerable population (child, prisoner, etc).

15. Subject is requesting or receiving Worker's compensation related to the knee injury

16. Inability to reply to online questionnaires because of mental impairment

17. Participation in another clinical investigation in the next two years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Justin W Moss, DHSc

Role: CONTACT

justin.moss@arthrex.com

770 584 4972

Alicia Ruiz

Role: CONTACT

alicia.ruiz@arthrex.com

Other Identifiers

AIRR-0065

Identifier Type: -

Identifier Source: org_study_id