Articular Cartilage Defect
Conditions
Keywords
cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
Brief summary
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.
Detailed description
This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.
Interventions
COMBINATION_PRODUCTNOVOCART 3D
Matrix associated autologous chondrocyte implant
Sponsors
Aesculap Biologics, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* participated in study AAG-G-H-1220 * identified as a microfracture failure patient * voluntary consent to participate in the study
Exclusion criteria
* other cartilage repair procedures performed on target knee * other conditions that would interfere with healing or evaluating outcomes * lesions requiring implants larger than 9cm2 * non-compliance with requirements in study AAG-G-H-1220
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS pain subdomain score | 24 months | Comparison of pain scores from the KOOS questionnaire from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS function subdomain score | 24 months | Comparison of function scores from the KOOS questionnaire from baseline |
| VAS pain scale | 24 months | Comparison of pain from baseline |
| IKDC subjective scores | 24 months | Comparison of IKDC subjective scores from baseline |
Countries
Canada, United States
Outcome results
None listed