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Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.
With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unicompartmental Biologic Arthroplasty | Active Comparator | Subject will be receiving a unicompartmental biologic arthroplasty only |
|
| Extensive Biologic Arthroplasty | Active Comparator | Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicompartmental Biologic Arthroplasty | Procedure | Unicompartmental Biologic Arthroplasty surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Score (Visual Analog Scale) | This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee Score (IKDC) | This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score. | 12 Months |
| Single Assessment Numeric Evaluation (SANE) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Stannard, MD | University of Missouri, Department of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Columbia | Missouri | 65202 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Extensive Biologic Arthroplasty | Procedure | Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently |
|
This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible
| 12 Months |
| PROMIS Mobility | This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility | 12 Months |
| D012216 |
| Rheumatic Diseases |