Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374491
Status:
WITHDRAWN
Last Update Posted:
2016-01-05
First Post:
2006-09-07
Brief Title:
The Long-term Degradation Outcome of Bilok Screws Used for ACL Reconstruction
Sponsor:
ArthroCare Corporation
Organization:
ArthroCare Corporation
Study Overview
Official Title:
The Long-term Degradation Outcome of Bilok Biodegradable Interference Fixation Screws Used for Bone-Patellar Tendon-Bone ACL Reconstruction
Status:
WITHDRAWN
Status Verified Date:
2016-01
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 purpose of the study is to evaluate the long term outcome of a poly L-lactic acid β-tricalcium phosphate BILOK biodegradable interference fixation screw used for arthroscopic bone-patellar tendon-bone ACL reconstructionto determine if these BILOK screws completely biodegrade as expected three years after implantation and to determine whether there is bone ingrowth into the defect remaining after resorption of the BILOK screw
Detailed Description:
BILOK screws have been used for ACL interference fixation in the US since the late 1990s As yet there are no long-term studies to demonstrate the eventual biologic outcome of these devices Animal studies indicate that the material used in BILOK implants completely degrades after 3 years but these reports do not indicate what takes their place Reports of other screw materials indicate that pure PLLA screws remain intact and can be removed whole at revision surgery in the first few months to years after implantation Recently a report of a biopsy at 2 years after surgery indicated that whole fragments of a PLLA screw were observed Schwach and Vert suggested that a PDLLA screw combination of dextro and levo stereoisomers completely degrade and is replaced by bone 3 years after surgery in sheep but no information is available for the human In addition to being limited and anecdotal most studies evaluating the degradation of biodegradable screws used in humans are conducted using plain radiographs and MRI to evaluate the status of the biodegradable screws A report by Bach et al evaluated the MRI appearance of a biodegradable interference screw composed of a different polymer polyglycolic acid 67 and trimethylene carbonate 33 in eight patients at 2 years It showed the reabsorption of the screw but suggested that MRI is not the most effective method for determining the bone ingrowth status in the area of the resorbed screws CT scanning is a better methodology than MRI for this application and was recently used to study the disappearance of a pure PLLA screw at least 7 years after implantation The purpose of this study is to evaluate the long-term resorption status of a Bilok screw and determine using CT scan what material replaces the screw
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20061028 | None | None | None |