Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Meniscus Lesion Clinical Trial

— STITCHRetro  

Official title:

Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097744
• Other study ID #: CTX-CP003
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: January 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Ceterix NovoStitch
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.

Locations

Country	Name	City	State
United States	Agility Center Orthopedics	Bentonville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation Rate	Data provided by patients	January 2015-February 2016
Primary	Validated patient-reported outcomes measures	IKDC Subjective	January 2015-February 2016
Primary	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