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
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERAMENT BVF | Device | CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute. |
| Measure | Description | Time Frame |
|---|---|---|
| Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months |
| Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months |
| Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months |
| Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months |
| Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological assessment at 6 and 12 months. Objective assessment of regeneration | Bone healing | 6 Months |
| Radiological assessment at 6 and 12 months. Objective assessment of regeneration | Bone healing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The racial, gender, and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily received CERAMENT BVF for the treatment of their condition at the designated investigative centers. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender or sexuality.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian M Bartholdi | Contact | 6178923927 | brian.bartholdi@bonesupport.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months |
| adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months |
| SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months |
| SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months |
| 12 Months |
| Pain VAS score | Pain assessment at 6,12, and 18 months | 6, 12, and 18 Months |
| EQ-5D-3L | Functional assessment at 6, 12, and 18 months | 6, 12, and 18 months |
| Golden Orthopedic Knee, Hip, Shoulder and Foot Center | Recruiting | Boca Raton | Florida | 33434 | United States |
|
| Sports and Orthopedic Center | Recruiting | Boca Raton | Florida | 33434 | United States |
|
| Dr. Peter Merkle | Recruiting | Pompano Beach | Florida | 33064 | United States |
|
| Florida Orthopedic Foot & Ankle Center | Recruiting | Sarasota | Florida | 34233 | United States |
|
| James Cottom | Recruiting | Sarasota | Florida | 34233 | United States |
|
| Indiana University | Terminated | Indianapolis | Indiana | 46202 | United States |
| OrthoIndy | Completed | Indianapolis | Indiana | 46278 | United States |
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| The Research Foundation of The State University of New York | Recruiting | Syracuse | New York | 13210 | United States |
|
| OrthoCarolina | Recruiting | Charlotte | North Carolina | 28207 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|