Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

NCT03097744 | Completed FDA Device

• 1 other identifier: CTX-CP003
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Medial Meniscus Tears; Meniscus Lesion; Meniscus; Rupture, Bucket Handle; Meniscus Disorder

Keywords

Lateral Meniscus Tear; Medial Meniscus Tear

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Agility Center Orthopedics

Bentonville, Arkansas, 72712, United States

Location

Related Publications (2)

• 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.

  PMID: 24265995 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.

  PMID: 23318612 BACKGROUND

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kathryn Olson

  Ceterix Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: February 1, 2017
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: September 7, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)