Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05405374
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2021-12-09
Brief Title:
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
Sponsor:
Bioventus LLC
Organization:
Bioventus LLC
Study Overview
Official Title:
A Prospective Randomized Intra-Patient Controlled Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures
Status:
RECRUITING
Status Verified Date:
2023-08
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:
SELECT
Brief Summary:
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft in terms of effectiveness and safety when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion LIF by means of an intra-patient control model
Detailed Description:
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures In particular the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion LIF procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease DDD degenerative spondylolisthesis andor mild degenerative scoliosis
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months
Safety will be evaluated by documenting the number and nature of all serious adverse events that may in any way be related to the surgical procedure or product The complication rate will be compared to the rate in control populations from literature
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months
Safety will be evaluated by documenting the number and nature of all serious adverse events that may in any way be related to the surgical procedure or product The complication rate will be compared to the rate in control populations from literature
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?:
True
Is an FDA AA801 Violation?:
None