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This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months.
The study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. The following clinical efficacy endpoints will be evaluated at greater than 12 months:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceterix NovoStitch | Device | The device allows the physician to place a circumferential compression stitch around meniscal tears. This stitch is placed by passing suture from the tibial side to the femoral side of the meniscus and across the tear. This allows compression across the entire tear surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation Rate | Data provided by patients | January 2015-February 2016 |
| Validated patient-reported outcomes measures | IKDC Subjective | January 2015-February 2016 |
| Contribution of the following retrospective covariates on failure and outcomes when available | Type of tear Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction | January 2015-February 2016 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals, 18-years-old or older, who have undergone a meniscus repair with a Ceterix NovoStitch device at least 12 months ago.
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Olson | Ceterix Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agility Center Orthopedics | Bentonville | Arkansas | 72712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24265995 | Background | Saliman JD. The circumferential compression stitch for meniscus repair. Arthrosc Tech. 2013 Jul 12;2(3):e257-64. doi: 10.1016/j.eats.2013.02.016. eCollection 2013. | |
| 23318612 | Background | Nepple JJ, Dunn WR, Wright RW. Meniscal repair outcomes at greater than five years: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012 Dec 19;94(24):2222-7. doi: 10.2106/JBJS.K.01584. |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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