Knee InjuryPhase 3NCT00793104

Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

A Phase 3 study testing Placement of allograft CR Plug in primary injury site in people with Knee Injury, run by RTI Surgical at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Knee Injury
What is being tested?: Placement of allograft CR Plug in primary injury site
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesUnited States
Study dates: Nov 2008to Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older
Skeletally mature
Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
Functional meniscal tissue (defined as 5 mm or more width)
A score of = or greater than 4 on the VAS questionnaire

Who cannot join

Associated tibial or patellar articular cartilage defect greater than 2 ICRS
Osteoarthritis of either knee
Mechanical axis malalignment of greater than 5 degrees
Patellofemoral incongruity of Merchant view
One or more multiple defects greater than 2.5 cm
Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm

Show all 13Show fewer

Ligament treatments in the affected knee within one yer prior to current study
Previous surgical meniscus treatments in the affected knee in the last 6 months
Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
Use of any investigational therapy with in 30 days prior to the first visit
Corticosteroid or viscosupplementation within the past 3 months
A score of 3 or less on the VAS Questionnaire
Active gout or pseudogout or systemic inflammatory condition

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Colorado Orthopedic Consultants
Denver, Colorado, 80012
OrthoIndy, Inc
Indianapolis, Indiana, 46237
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, 90045

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 Focal Cartilage Lesions in the Femoral Condyle

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Read the detailed description

The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

Conditions: Knee Injury
Being tested: Placement of allograft CR Plug in primary injury site
Keywords: allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage
Medical subject headings: Knee Injuries

What participants receive

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

Placement of allograft CR Plug in primary injury siteProcedure or surgery
Core defect and implant allograft CR plug

Study groups in NCT00793104
Study group	Role	What they receive
CR Plug	Other	Placement of allograft CR Plug in primary injury site Receives: Procedure: Placement of allograft CR Plug in primary injury site

What is being measured

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

The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 24 months

Secondary outcomes (4)

Current Health Assessment
Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 24 months, MRI only at 12 and 24 months
Lysholm With Tegner Score
The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.
Measured: 24 months
International Knee Documentation Committee (IKDC) at 24 Months.
The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 24 months
MRI Evaluation Score
MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.
Measured: 24 months

Timeline

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

Nov 2008Mar 2012

First posted19 Nov 2008 (estimated)
Study startNov 2008
Primary completionMar 2012
Study completionMar 2012

Why it stopped: Slow enrolment \& potential regulatory changes for allograft in cartilage repair

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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00793104
Sponsor's protocol ID: CRP2008
Other IDs: WIRB # 20081109, St Francis IRB Project # 571
Status last verified: Nov 2013
First submitted: 17 Nov 2008
Last updated: 25 Dec 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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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 25 Dec 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 Focal Cartilage Lesions in the Femoral Condyle
ClinicalTrials.gov ID: NCT00793104
Acronym / sponsor ID: CRP2008
Conditions: Knee Injury
Keywords: allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrolment \& potential regulatory changes for allograft in cartilage repair
Enrolment: 10 participants (actual)
Lead sponsor: RTI SurgicalIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 25 Dec 2013

Clinical summary

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

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Detailed description

The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

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	Other	Procedure: Placement of allograft CR Plug in primary injury sitePlacement of allograft CR Plug in primary injury site

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years of age or older
Skeletally mature
Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
Functional meniscal tissue (defined as 5 mm or more width)
A score of = or greater than 4 on the VAS questionnaire

Key exclusion criteria (13 listed)

Associated tibial or patellar articular cartilage defect greater than 2 ICRS
Osteoarthritis of either knee
Mechanical axis malalignment of greater than 5 degrees
Patellofemoral incongruity of Merchant view
One or more multiple defects greater than 2.5 cm

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
Placement of allograft CR Plug in primary injury siteCore defect and implant allograft CR plug	Procedure or surgery	CR Plug

Primary outcome

The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
Time frame: 24 months
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

4 secondary outcomes

Current Health Assessment
Time frame: 24 months, MRI only at 12 and 24 months
Lysholm With Tegner Score
Time frame: 24 months
International Knee Documentation Committee (IKDC) at 24 Months.
Time frame: 24 months
MRI Evaluation Score
Time frame: 24 months

Results and safety

Results posted to the registry on 25 Dec 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	10	9

Primary outcome: The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months

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

Measure	CR Plug n = 9
Value	86.04 (17.44)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CR Plug	2 of 10 (20%)	10 of 10 (100%)	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 1 patient was lost to follow up, with no data collected at the 24-month visit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here to find more information from OrthoIndyLink provided by the sponsor.

Related trials for Knee Injury

Not yet recruiting
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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
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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, PhD principal investigator

OrthoIndy, Inc

Ralph A Gambardella, MD principal investigator

Kerlan Jobe Orthopaedic Clinic

Stewart Weinerman, MD principal investigator

Colorado Orthopedic Consultants

3 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 Placement of allograft CR Plug in primary injury site in people with Knee Injury, run by RTI Surgical at 3 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 25 Dec 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?

The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months (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 NCT00793104.

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 25 Dec 2013.