Clinical trial NCT05491564: SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
Official title: SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meniscus Tear
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals recommended to undergo meniscal repair using SoftStitch™ in routine clinical practice will be considered for participation in this study.

50 subjects, male and female, ≥ 18 years old who have been legally consented and meet the eligibility criteria will be enrolled at the time of surgery.

Subjects will be recruited from the principal investigator's patient population or referrals from other physicians.

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.


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

Primary outcomes:
measure: Lysholm Score
timeFrame: Collected at baseline, 6 weeks, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
measure: Tegner Activity Scale
timeFrame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
measure: International Knee Documentation Committee (IKDC) Subjective Measure
timeFrame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
timeFrame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
measure: McMurray Test
timeFrame: Collected at baseline, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: