Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05337696
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2022-03-26
Brief Title:
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
Status:
RECRUITING
Status Verified Date:
2024-05
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:
RECONSTRUCT
Brief Summary:
The RECONSTRUCT study is a multi-center prospective single arm post-market pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK VIP implant in the treatment of symptomatic acute 8week vertebral compression fractures who have failed conservative care strategies
Detailed Description:
Vertebral compression fractures affect an estimated 14 million patients in the world annually and incidence rates rise exponentially with age especially in women Outcomes following non-interventional management of these injuries are generally poor largely as a consequence of opioid requirements prolonged immobilization and bedrest As a result interventional techniques such as balloon kyphoplasty and vertebroplasty with or without implantable devices are currently regarded as the standard of care for select patients with acute painful osteoporotic compression fractures These procedures relieve fracture pain by stabilizing the fracture site using cement
Alternative interventional techniques include percutaneous vertebral augmentation which combine cement injection with implantable devices such as the SpineJack and KIVA devices The RECONSTRUCT study will build on the outcomes of the SAKOS and KAST clinical trails that evaluated the SpineJack and KIVA devices respectively
The Vertebral Implant PEEK VIP implant V-STRUT manufactured by Hyprevention has undergone both clinical and pre-clinical testing Static and dynamic bending of the implant has been evaluated to demonstrate that the product is capable of supporting in-situ loading and increase fracture load and energy to fracture
A total of 30 eligible subjects with a diagnosis of osteoporotic fractures of the thoracolumbar spine as confirmed by MRI scan and who are treated with the Vertebral Implant PEEK VIP device will be asked to join the study No placebo or control will be utilized during this study
RECONSTRUCT has been designed with the intention of achieving two goals 1 to inform the design of larger controlled clinical trials in the future and 2 to assess the safety of the study device within the patient sample
Alternative interventional techniques include percutaneous vertebral augmentation which combine cement injection with implantable devices such as the SpineJack and KIVA devices The RECONSTRUCT study will build on the outcomes of the SAKOS and KAST clinical trails that evaluated the SpineJack and KIVA devices respectively
The Vertebral Implant PEEK VIP implant V-STRUT manufactured by Hyprevention has undergone both clinical and pre-clinical testing Static and dynamic bending of the implant has been evaluated to demonstrate that the product is capable of supporting in-situ loading and increase fracture load and energy to fracture
A total of 30 eligible subjects with a diagnosis of osteoporotic fractures of the thoracolumbar spine as confirmed by MRI scan and who are treated with the Vertebral Implant PEEK VIP device will be asked to join the study No placebo or control will be utilized during this study
RECONSTRUCT has been designed with the intention of achieving two goals 1 to inform the design of larger controlled clinical trials in the future and 2 to assess the safety of the study device within the patient sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None