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Slow enrolment & potential regulatory changes for allograft in cartilage repair
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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 of smaller, focal defects (like the injury the patient has to their knee).
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary injury site | Other | CR-Plug will be placed in the site of the primary injury |
|
| Backfill site | Other | Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary injury site | Other | Autograft will be placed in the primary defect site. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS | 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 (CHA) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akbar Nawab, MD | Ellis and Badenhausen Orthopaedics, PSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ellis and Badenhausen Orthopaedics, PSC | Louisville | Kentucky | 40202 | United States |
Patients were assigned to the treatment arm based on a randomization table. Enrolled patients excluded: Not fulfilling inclusion or exclusion criteria, withdrawal of consent. Enrolled patients were followed to completion unless lost to follow up. Of 4 enrolled, 1 withdrew consent, 1 was lost to follow up & 2 completed
All participants were recruited from the patient population at one of the investigative sites between 12 June 2009 and 5 May 2010.
One subject was enrolled at 17 years, 7 months. A protocol waiver was approved by the Institutional Review Board and parental informed consent and assent of subject was obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | Backfill | Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site. |
| FG001 | Primary | CR Plug will be placed in the site of the primary injury. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
There are only 3 patients in the baseline analysis due to one patient withdrawing from the study before data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Backfill | Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site |
| BG001 | Primary | CR Plug will be placed in the site of the primary injury |
| 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 | Knee Injury and Osteoarthritis Outcome Score (KOOS | 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. | Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient. | Posted | Mean | Full Range | units on a scale | 24 months |
|
Patients were followed through the termination of the study, i.e. 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 | Backfill | CR-Plug will be placed in harvest site. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain in right knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Enrollment was closed early due to slow enrollment & a potential change in the regulatory pathway for the allograft used in cartilage repair.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Projects | RTI Biologics | 386-418-8888 | 4172 | 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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| Backfill site |
| Other |
Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site. |
|
| IKDC Assessment |
The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score, |
| 24 months |
| Magnetic Resonance Imaging (MRI) Results | 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 |
| Lysholm Score at 24 Months | The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | 24 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| 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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CR Plug will be placed in the site of the primary injury |
|
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| Secondary | Current Health Assessment (CHA) | 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. | Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient. | Posted | Mean | Full Range | units on a scale | 24 months |
|
|
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| Secondary | IKDC Assessment | The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score, | Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient. | Posted | Mean | Full Range | units on a scale | 24 months |
|
|
|
| Secondary | Magnetic Resonance Imaging (MRI) Results | 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. | Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient. | Posted | Mean | Full Range | units on a scale | 24 months |
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|
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| Secondary | Lysholm Score at 24 Months | The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. | Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient. | Posted | Mean | Full Range | units on a scale | 24 months |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Primary | Autograft will be placed in primary defect site. | 0 | 1 | 1 | 1 |
| Increased swelling in right knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Motor Vehicle Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Open Reduction Internal Fixation of talus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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