Clinical trial NCT03097744: Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs
Official title: Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Medial Meniscus Tears
Meniscus Lesion
Meniscus; Rupture, Bucket Handle
Meniscus Disorder
Keywords: Lateral Meniscus Tear
Medial Meniscus Tear
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals, 18-years-old or older, who have undergone a meniscus repair with a Ceterix NovoStitch device at least 12 months ago.

Brief summary: 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.

Detailed description: 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:

* Reoperation rate
* Validated patient-reported outcomes measures
* 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.

Eligibility criteria: Inclusion Criteria:

* Able and willing to give consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
* In the opinion of the Investigator are able to comply with study-required follow-up

Exclusion Criteria:

* Post-operative interval \<1year
* Concurrent bony fractures
* Post-operative reinjury (except the meniscus)
* Pre-operative arthritis grade 3 or higher on modified outerbridge
* Knee surgery prior to meniscus repair surgery
* Any kind of infection

Primary outcomes:
measure: Reoperation Rate
timeFrame: January 2015-February 2016
measure: Validated patient-reported outcomes measures
timeFrame: January 2015-February 2016
measure: Contribution of the following retrospective covariates on failure and outcomes when available
timeFrame: January 2015-February 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Agility Center Orthopedics
state: Arkansas
Study officials:
affiliation: Ceterix Orthopaedics
name: Kathryn Olson
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.