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Clinical Application of BioCleanse Meniscus (Meniscus)

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ClinicalTrials.gov Identifier: NCT00659880
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

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

Condition or disease Intervention/treatment
Tear of Meniscus of Knee Other: BioCleanse Meniscus

Detailed 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.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Application of BioCleanse Meniscus Registry
Study Start Date : April 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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


Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients, between the ages of 18 and 55 years, who have selected meniscal allograft transplantation (MAT) using BioCleanse allografts will be eligible to participate in the MAT registry.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Anyone not eligible for a meniscal transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659880


Locations
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United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46237
Sponsors and Collaborators
RTI Surgical
Investigators
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Principal Investigator: Jack Farr, MD OrthoIndy -Orthopaedic Research Foundation, Inc

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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00659880     History of Changes
Other Study ID Numbers: BioMen
First Posted: April 16, 2008    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by RTI Surgical:
Meniscus transplant
Meniscal allograft
MAT
Knee