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This study will follow patients after routine surgery of a meniscal allograft transplant.
The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCleanse Meniscus | Other | Subjects will undergo routine meniscal allograft transplant surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI Assessments | MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn. Images were also assessed for oedema in each of these 3 regions of the meniscus. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients, between the ages of 18 and 55 years, who have selected meniscal allograft transplantation (MAT) using BioCleanse allografts will be eligible to participate in the MAT registry.
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| Name | Affiliation | Role |
|---|---|---|
| Jack Farr, MD | OrthoIndy -Orthopaedic Research Foundation, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoIndy | Indianapolis | Indiana | 46237 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meniscal Allograft Transplant | Patients who received a BioCeanse Meniscal Allograft Transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Meniscal Allograft Transplant | Patients who received a BioCeanse Meniscal Allograft Transplant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms.
Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
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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 | Meniscal Allograft Transplant | Patients who received a BioCeanse Meniscal Allograft Transplant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ipsilateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Waite, RN | RTI Surgical | 386-418-8888 | rwaite@rtix.com |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | MRI Assessments | MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn. Images were also assessed for oedema in each of these 3 regions of the meniscus. | Posted | Number | participants | 12 months |
|
|
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| 0 |
| 9 |
| 4 |
| 9 |
| arm fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee impinging scar | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chondrosis: Trochlea & Patella | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| meniscal allograft lesion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral (non-study) knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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PI may present/publish in meetings, journals, theses, dissertations the results of Investigation provided that RTI will have been furnished copies of any proposed publication/presentation at least 40 days in advance of the submission. RTI will have 30 days after receipt to object & withhold consent to the proposed presentation/publication either because there is patentable subject matter which needs protection and or there is Confidential or inaccurate information contained in the publication
| Title |
|---|
| Measurements |
|---|
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| Mild Edema Anterior Horn |
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| Mild Edema Posterior Horn |
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| Mild Edema Meniscal Body |
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