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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB #20080290 | Other Identifier | Western IRB |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR Plug BackFill | Experimental | Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CR Plug | Other | CR Plug will be placed in the harvest site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Carter, MD | The Orthopedic Clinic, Assoc | Principal Investigator |
| David Flanigan, MD | The Ohio State Univesity | Principal Investigator |
| Phillip Stull, MD | Colorado Orthopedic Consultants | Principal Investigator |
| Jeffrey Dugas, MD | American Sports Medicine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Sports Medicine Institute | Birmingham | Alabama | 35205 | United States | ||
| The Orthopedic Clinic Assoc |
This was a single arm study, thus there is no assignment
All participants were recruited from the patient population at the four investigative sites
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| ID | Title | Description |
|---|---|---|
| FG000 | CR Plug BackFill | Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CR Plug BackFill | Evaluation of the CR Plug for Repair of Defects Created at the Harvest 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 | 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. | 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 | Adverse Events | Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Collapse of Graft | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Interval Collapse in Size of Central Defect within the Anterior Lateral Femoral Condyle (per MRI) |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Waite, 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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| Phoenix |
| Arizona |
| 85016 |
| United States |
| Colorado Orthopedic Consultants | Englewood | Colorado | 80110 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 9 |
| 6 |
| 9 |
|
| PAIN IN RIGHT KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | NOT related |
|
| VOMITING NAUSEA | Gastrointestinal disorders | Non-systematic Assessment | unlikely related |
|
| MEDICATION REACTION | General disorders | Non-systematic Assessment | NOT related |
|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment | NOT RELATED |
|
| FELL ON KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | NOT RELATED |
|
| PAIN RIGHT KNEE FROM FALL | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | NOT related |
|
| PAIN IN RIGHT KNEE FORM COLD | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | UNLIKELY RELATED |
|
| SWELLING IN RIGHT KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | NOT RELATED |
|
| ABDOMINAL PAIN | General disorders | Non-systematic Assessment | NOT RELATED |
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| TRANSIENT KNEE EFFUSION | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | UNLIKELY RELATED |
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| CHEST PAIN | General disorders | Non-systematic Assessment | NOT RELATED |
|
| INFECTION OF LEFT KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | UNLIKELY RELATED |
|
| RIGHT LEG SWELLING | General disorders | Non-systematic Assessment | NOT RELATED |
|
| INCREASED KNEE EFFUSION DUE TO FALL | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | NOT RELATED |
|
| DEPRESSION | Psychiatric disorders | Non-systematic Assessment | NOT RELATED |
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| QUADRICEPS ATROPHY - IPSILATERAL LEG | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | UNLIKELY RELATED |
|
| KIDNEY STONES | General disorders | Non-systematic Assessment | NOT RELATED |
|
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