Tear of Meniscus of KneeMeniscusNCT00659880

Clinical Application of BioCleanse Meniscus

An observational study of Tear of Meniscus of Knee, run by RTI Surgical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will follow patients after routine surgery of a meniscal allograft transplant. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Tear of Meniscus of Knee
What is being tested?: BioCleanse Meniscus
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Jul 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

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.

Who may be able to join

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

Who cannot join

Anyone not eligible for a meniscal transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

OrthoIndy
Indianapolis, Indiana, 46237

Other trials in United States

About this study

Official title: Clinical Application of BioCleanse Meniscus Registry

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

Read the 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.

Conditions: Tear of Meniscus of Knee
Being tested: BioCleanse Meniscus
Keywords: Meniscus transplant, Meniscal allograft, MAT, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioCleanse MeniscusOther
Subjects will undergo routine meniscal allograft transplant surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 months

Secondary outcomes (1)

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jul 2015

First posted16 Apr 2008 (estimated)
Study startApr 2008
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tear of Meniscus of KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659880
Sponsor's protocol ID: BioMen
Acronym: Meniscus
Status last verified: Apr 2017
First submitted: 14 Apr 2008
Last updated: 26 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Application of BioCleanse Meniscus Registry
ClinicalTrials.gov ID: NCT00659880
Acronym / sponsor ID: Meniscus / BioMen
Conditions: Tear of Meniscus of Knee
Keywords: Meniscus transplant, Meniscal allograft, MAT, Knee
Study type: Observational
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: RTI SurgicalIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 26 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Anyone not eligible for a meniscal transplant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BioCleanse MeniscusSubjects will undergo routine meniscal allograft transplant surgery.	Other	–

Primary outcome

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.

1 secondary outcome

MRI Assessments
Time frame: 12 months

Results and safety

Results posted to the registry on 26 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meniscal Allograft Transplant	9	4

Primary outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame: 60 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Meniscal Allograft Transplant n = 4
Value	70.1 (33.6)

Meniscal Allograft Transplant: p = 0.06, Friedman

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meniscal Allograft Transplant	0 of 9 (0%)	4 of 9 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jack Farr, MD principal investigator

OrthoIndy -Orthopaedic Research Foundation, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tear of Meniscus of Knee, run by RTI Surgical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00659880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.