NCT00659880

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

April 1, 2017

Enrollment Period

7.3 years

First QC Date

April 14, 2008

Results QC Date

September 12, 2016

Last Update Submit

April 10, 2017

Conditions

Tear of Meniscus of Knee

Keywords

Meniscus transplantMeniscal allograftMATKnee

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 months

Secondary Outcomes (1)

  • MRI Assessments

    12 months

Interventions

BioCleanse MeniscusOTHER

Subjects will undergo routine meniscal allograft transplant surgery.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Anyone not eligible for a meniscal transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoIndy

Indianapolis, Indiana, 46237, United States

Location

Results Point of Contact

Title
Robin Waite, RN
Organization
RTI Surgical
rwaite@rtix.com
386-418-8888

Study Officials

  • Jack Farr, MD

    OrthoIndy -Orthopaedic Research Foundation, Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 26, 2017

Results First Posted

June 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)