Clinical Application of BioCleanse Meniscus

Tear of Meniscus of Knee Clinical Trial

— Meniscus  

Official title:

Clinical Application of BioCleanse Meniscus Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659880
• Other study ID #: BioMen
• Status: Completed
• Phase: Phase 4
• First received: April 14, 2008
• Last updated: July 17, 2015
• Start date: April 2008
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will follow patients after routine surgery of a meniscal allograft transplant.

Description:

The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients, up to 10 who have selected a BioCleanse Meniscus transplant

Exclusion Criteria:

• Anyone not eligible for a meniscal transplant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tear of Meniscus of Knee

Intervention

Other:
• BioCleanse Meniscus
Subjects will undergo routine meniscal allograft transplant surgery.

Locations

Country	Name	City	State
United States	OrthoIndy	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective subject questionnaire scores as well as X-ray and MRI evaluations		Subject questionnaires at 4 weeks, 6 months, 12 months, 24 months and 60 months. X-rays at 4 weeks and 12 months. MRI at 6 months (optional) and 12 months.	No