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

Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00793104

Enrollment

Registered

2008-11-19

Start date

2008-11-30

Completion date

2012-03-31

Last updated

2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injury

Keywords

allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage

Brief summary

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.

Interventions

PROCEDUREPlacement of allograft CR Plug in primary injury site

Core defect and implant allograft CR plug

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame	Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months	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.

Secondary

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

Countries

United States

Participant flow

Recruitment details

All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.

Pre-assignment details

There was no group assignment

Participants by arm

Arm	Count
CR Plug Placement of allograft CR Plug in primary injury site	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	CR Plug
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	10 Participants
Age Continuous	36.9 years STANDARD_DEVIATION 8.2
Region of Enrollment United States	10 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 10
serious Total, serious adverse events	2 / 10

Arm	Measure	Value (MEAN)	Dispersion
CR Plug	MRI Evaluation Score	95.5 units on a scale	Standard Deviation 7.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026