Clinical Application of BioCleanse Meniscus

RTI Surgical9 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tear of Meniscus of Knee

Interventions

BioCleanse MeniscusOTHER

Subjects will undergo routine meniscal allograft transplant surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients, up to 10 who have selected a BioCleanse Meniscus transplant Exclusion Criteria: * Anyone not eligible for a meniscal transplant

Locations (1)

OrthoIndy

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)

The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.

Time frame: 60 months

Secondary Outcomes

MRI Assessments

MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn. Images were also assessed for oedema in each of these 3 regions of the meniscus.

Time frame: 12 months

Data from ClinicalTrials.gov

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