Diskectomy Clinical Trial
Official title:
Randomized Study of Anular Repair With the Xclose Tissue Repair System
The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.
Discectomy surgery is intended to remove the impinging fragment on the nerve root thus
alleviating the pain and providing the nerve with a better healing environment. Discectomy
procedures entail removing a bony portion of the vertebral body to access the posterior side
of the disc space, and then removing the impinging fragment from the disc. The fragment
being removed can either be contained within the wall of the anulus, which requires incision
into the anulus to remove it, or it could be extruded through an anular fissure. In the
absence of a safe and easy method to close or seal the defect in the anulus following a
discectomy procedure, surgeons are left with no alternative but to leave the anulus in this
compromised state which is largely the current practice. This rent in the soft tissue of the
anulus fibrosus can lead to postoperative problems if the remaining nuclear tissue in the
disc pushes through the anular defect or incision causing recurrent or persistent pain.
Initial studies involved the placement of sutures to seal the anular defect. This work
strongly suggested that microsurgical anular reconstruction can reduce recurrent herniations
and re-operations, post discectomy. Unfortunately, this technique is not easy to perform and
may pose an increased risk to the patient.
This study utilizes the Xclose™ Tissue Repair System to re-approximate the compromised
tissue of the anulus fibrosus in appropriately randomized patients in an effort to quantify
the benefits of anular repair for discectomy patients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06358040 -
Opioid Dispenser for Microdiscectomy/Laminectomy
|
N/A | |
Completed |
NCT00868335 -
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
|
N/A |