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OpenTrials
Completed

NCT Number: NCT03097744

Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Agility Center Orthopedics

Bentonville, Arkansas, 72712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reoperation Rate

    Time frame: January 2015-February 2016

    Data provided by patients

  2. Validated patient-reported outcomes measures

    Time frame: January 2015-February 2016

    IKDC Subjective

  3. Contribution of the following retrospective covariates on failure and outcomes when available

    Time frame: January 2015-February 2016

    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

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Acronym: STITCHRetro

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2017
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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