Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-11
Brief Title:
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Sponsor:
AlloSource
Organization:
AlloSource
Study Overview
Official Title:
A Prospective Open Label Single-Arm Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle
Detailed Description:
Patients between the ages of 12 years and 60 years who have a symptomatic full-thickness cartilage lesion Grade 3 or 4 on the femoral condyle in a mechanically stable knee or is being mechanically stabilized in the same procedure between 20-80 cm2 in size and cystic changes requiring osseous repair present in less than or equal to 12 mm of subchondral bone as confirmed by Magnetic Resonance Imaging MRI or arthroscopy and undergoing an osteochondral transplant procedure will be eligible for enrollment Patients will receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage
Patients will be followed for up to 60 months post-procedure 6 weeks 3 months 6 months 12 months 24 months 36 months 48 months and 60 months to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores
Patients will be followed for up to 60 months post-procedure 6 weeks 3 months 6 months 12 months 24 months 36 months 48 months and 60 months to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None