Randomized Study of Anular Repair With the Xclose Tissue Repair System

Anulex Technologies

Status and phase

Completed

Phase 4

Conditions

Diskectomy

Treatments

Procedure: Discectomy with anular repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT00760799

06101_B

Details and patient eligibility

About

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

Full 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.

Enrollment

750 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Candidate for a one or two level discectomy
Positive imaging evidence of intervertebral disc herniation at location corresponding to patient's radicular signs or symptoms
Anular tear or slit incision and additionally deemed to include sufficient tissue for tissue reapproximation
Persistent and predominant radicular pain
Pre-operative leg pain score > 4.0 cm on a 10 cm Visual Analog Scale (VAS)
Leg pain unresponsive to conservative treatment (physical therapy and non-steroidal anti-inflammatory medical therapy) for 6 or more weeks; exception, individuals suffering from acute and uncontrollable severe leg pain
Patient is willing and able to comply with study requirements; willing and able to sign a study-specific, informed consent form, complete necessary study paperwork and return for required follow-up visits.

Exclusion criteria

Age less than 18 years
Prior or planned surgical procedure intended to fuse or stabilize the lumbar spine
Previous surgery involving index level
Cauda Equina Syndrome
Evidence of severe disc degeneration
Greater than Grade I spondylolisthesis or retrolisthesis at the affected level
No apparent anular defect and no indication to open the anulus at time of procedure
Active local or systemic infection
Active malignancy or other significant medical co-morbidities
Current chemical dependency or significant emotional and/or psychosocial disturbance that would impact treatment outcome or study participation
Patient or legal guardians who are unwilling or unable to cooperate or give written informed consent
Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Current fracture, tumor and/or deformity (> 15° of lumbar scoliosis, using Cobb measuring technique) of the spine
Documented history of allergy or intolerance to PET
Patient is currently enrolled in other research that could confound the results of the study.