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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB # 20081109 | Other Identifier | Western IRB | |
| St Francis IRB Project # 571 | Other Identifier | St. Francis IRB |
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Slow enrolment & potential regulatory changes for allograft in cartilage repair
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Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR Plug | Other | Placement of allograft CR Plug in primary injury site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of allograft CR Plug in primary injury site | Procedure | Core defect and implant allograft CR plug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months, MRI only at 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Farr, MD, PhD | OrthoIndy, Inc | Principal Investigator |
| Ralph A Gambardella, MD | Kerlan Jobe Orthopaedic Clinic | Principal Investigator |
| Stewart Weinerman, MD | Colorado Orthopedic Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerlan Jobe Orthopaedic Clinic | Los Angeles | California | 90045 | United States | ||
| Colorado Orthopedic Consultants |
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| Label | URL |
|---|---|
| Click here to find more information from OrthoIndy | View source |
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There was no group assignment
All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | CR Plug | Placement of allograft CR Plug in primary injury site |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CR Plug | Placement of allograft CR Plug in primary injury site |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CR Plug | Placement of allograft CR Plug in primary injury site |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft Failure | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild knee effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Waite , Clinical Projects Director | RI Biologics | 386-418-8888 | rwaite@rtix.com |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 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. | 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. | 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. | 24 months |
| Denver |
| Colorado |
| 80012 |
| United States |
| OrthoIndy, Inc | Indianapolis | Indiana | 46237 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months, MRI only at 12 and 24 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
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| 2 |
| 10 |
| 10 |
| 10 |
| Moderate knee effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| reduced rom, KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
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| whole body itching | General disorders | Non-systematic Assessment |
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| tingling sensation in foot | General disorders | Non-systematic Assessment |
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| knee catching | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| meniscus tear | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| plug protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| knee pain, mild | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| knee pain, moderate | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| knee pain after activity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| increased knee pain, moderate | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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