Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs (STITCHRetro)

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion; Meniscus Disorder; Knee Medial Meniscus Tears; Meniscus; Rupture, Bucket Handle
• Intervention / Treatment: Device: Ceterix NovoStitch

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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Agility Center Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Kathryn Olson, Ceterix Orthopaedics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): April 20, 2018
• Study Completion (ACTUAL): April 20, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (ACTUAL): March 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Lateral Meniscus Tear; Medial Meniscus Tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: CTX-CP003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No