Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Costal Cartilage Graft | Other | Patients undergoing rhinoplasty will receive autologous rib graft. |
|
| Costal Cartilage Allograft | Other | Patients undergoing rhinoplasty will receive costal cartilage allograft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Costal Cartilage Graft | Other | Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for preoperative assessment. | Preoperative |
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 3 months post-operative |
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 6 months post-operative |
| Patient Outcome Assessment | Subjective assessment using the Face-Q checklists and scoring for post-operative assessments. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc. | 12 months | |
| Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: occurrence of adverse events (AEs) | Evaluation of the occurrence of adverse events (AEs) as documented by the treating physician during the course of treatment and follow-up visits and as reported by the subjects at each Assessment Visit. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Costal Cartilage Allograft. | Other | Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention. |
|
| 12 months |