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OpenTrials
Completed

NCT Number: NCT00659880

Clinical Application of BioCleanse Meniscus

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

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Key information

Conditions

Tear of Meniscus of Knee

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OrthoIndy

Indianapolis, Indiana, 46237, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Anyone not eligible for a meniscal transplant

Treatment and study plan

BioCleanse Meniscus

Other

Subjects will undergo routine meniscal allograft transplant surgery.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 60 months

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

Secondary outcomes

  1. MRI Assessments

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Official study title

Clinical Application of BioCleanse Meniscus Registry

Acronym: Meniscus

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2008
Registry last updated
Jun 26, 2017

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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