Knee InjuryPhase 3CRBNCT00821873

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

A Phase 3 study testing CR Plug in people with Knee Injury, run by RTI Surgical at 4 sites in United States.

Completed

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

Trial summary

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Knee Injury
What is being tested?: CR Plug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 4 sitesUnited States
Study dates: Dec 2008to Jul 2012
Phase: Phase 3
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

Who may be able to join

Are male or female at least 18 years of age and up to 55 years of age
Must be skeletally mature
Have a grade III or IV lesion in femoral condyle

Who cannot join

Skeletally immature
Osteoarthritic knees, osteonecrotic knees, osteophyte formation
Use of any investigational therapy within thirty (30) days prior to the first visit

Trial locations and contacts

4 sites in 1 country.

United States4 sites

American Sports Medicine Institute
Birmingham, Alabama, 35205
Ohio State University
Columbus, Ohio, 43221
Colorado Orthopedic Consultants
Englewood, Colorado, 80110
The Orthopedic Clinic Assoc
Phoenix, Arizona, 85016

Other trials in United States

About this study

Official title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Read the detailed description

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Conditions: Knee Injury
Being tested: CR Plug
Keywords: Cartilage injury, OATS, Knee injury, allograft, autograft
Medical subject headings: Knee Injuries

What participants receive

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

CR PlugOther
CR Plug will be placed in the harvest site

Study groups in NCT00821873
Study group	Role	What they receive
CR Plug BackFill	Experimental	Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site Receives: Other: CR Plug

What is being measured

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

MRI to Evaluate Success of Outcome.
The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.
The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.
Measured: 24 months

Timeline

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

Dec 2008Jul 2012

First posted14 Jan 2009 (estimated)
Study startDec 2008
Primary completionJul 2012
Study completionJul 2012

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 Knee InjuryStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00821873
Sponsor's protocol ID: CRB2008
Other IDs: WIRB #20080290
Acronym: CRB
Status last verified: Nov 2013
First submitted: 12 Jan 2009
Last updated: 28 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Stair Biomechanics and Vibration Study After ACLR
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
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Not yet recruiting
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All Knee Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure
ClinicalTrials.gov ID: NCT00821873
Acronym / sponsor ID: CRB / CRB2008
Conditions: Knee Injury
Keywords: Cartilage injury, OATS, Knee injury, allograft, autograft
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: RTI SurgicalIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 14 Jan 2009 (estimated)
Results: Posted 6 Nov 2013

Clinical summary

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

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CR Plug BackFill	Experimental	Other: CR PlugEvaluation of the CR Plug for Repair of Defects Created at the Harvest Site

Who may qualify

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

Key inclusion criteria (3 listed)

Are male or female at least 18 years of age and up to 55 years of age
Must be skeletally mature
Have a grade III or IV lesion in femoral condyle

Key exclusion criteria (3 listed)

Skeletally immature
Osteoarthritic knees, osteonecrotic knees, osteophyte formation
Use of any investigational therapy within thirty (30) days prior to the first visit

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
CR PlugCR Plug will be placed in the harvest site	Other	CR Plug BackFill

Primary outcome

MRI to Evaluate Success of Outcome.
Time frame: 24 months
The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.

Results and safety

Results posted to the registry on 6 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CR Plug BackFill	9	5

Primary outcome: MRI to Evaluate Success of Outcome.

Time frame: 24 months. Mean (Standard Deviation). Unit: units on a scale

Measure	CR Plug BackFill n = 5
Value	88.6 (5.7)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events	0 of 9 (0%)	6 of 9 (66.7%)	Not reported

Limitations and caveats (from the sponsor): Enrollment was closed early due for 2 factors: 1\) Slow enrollment and 2) A potential change in the regulatory pathway for allografts used in cartilage repair. Of the 9 patients enrolled, 4 were lost to follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Injury

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes

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.

Thomas Carter, MD principal investigator

The Orthopedic Clinic, Assoc

David Flanigan, MD principal investigator

The Ohio State Univesity

Phillip Stull, MD principal investigator

Colorado Orthopedic Consultants

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CR Plug in people with Knee Injury, run by RTI Surgical at 4 sites 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 3 inclusion and 3 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2013). 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?

MRI to Evaluate Success of Outcome. (time frame: 24 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 NCT00821873.

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 28 Nov 2013.