NCT00760799

Randomized Study of Anular Repair With the Xclose Tissue Repair System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Anulex Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.

Detailed description

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.

Conditions

• Diskectomy

Interventions

Type	Name	Description
PROCEDURE	Discectomy with anular repair	Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2008-09-26
• Last updated: 2012-05-02

Locations

34 sites across 1 country: United States