Randomized Study of Anular Repair With the Xclose Tissue Repair System

NCT ID: NCT00760799

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Standard discectomy without anular repair

Group Type: ACTIVE_COMPARATOR

Discectomy with anular repair

Intervention Type: PROCEDURE

Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc

2

Standard Discectomy with anular repair

Group Type: EXPERIMENTAL

Discectomy with anular repair

Intervention Type: PROCEDURE

Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc

Interventions

Discectomy with anular repair

Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc

Intervention Type: PROCEDURE

Other Intervention Names

Repair of the anulus fibrosus following discectomy.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anulex Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Alabama Neurological, P.A.

Huntsville, Alabama, United States

Texas Back Institute

Phoenix, Arizona, United States

Desert Institute for Spine Care

Phoenix, Arizona, United States

University of California San Diego

San Diego, California, United States

Denver Spine (Porter Hospital)

Greenwood Village, Colorado, United States

Denver Spine (Presbyterian/St. Luke's Hospital)

Greenwood Village, Colorado, United States

North Florida Regional Hospital

Gainesville, Florida, United States

Lyerly Neurosurgical (Baptist Health)

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Lyerly Neurosurgical (Centerone)

Jacksonville, Florida, United States

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Chicago Institute of Neurosurgery and Neuroresearch

Chicago, Illinois, United States

Palos Community Hospital

Palos Heights, Illinois, United States

Indiana Spine Group

Indianapolis, Indiana, United States

Heartland Spine

Overland Park, Kansas, United States

New England Baptist

Boston, Massachusetts, United States

Oakwood Hospital

Dearborn, Michigan, United States

Henry Ford

Detroit, Michigan, United States

Central Minnesota Neurosciences

Sartell, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hudson Valley Neurosurgical Associates

Suffern, New York, United States

Capital Neurosurgery

Raleigh, North Carolina, United States

Atlantic Neurosurgical & Spine

Wilmington, North Carolina, United States

Pennsylvania Spine Institute

Harrisburg, Pennsylvania, United States

West Penn Neurosurgery Group

Pittsburgh, Pennsylvania, United States

Our Lady of Fatima Hospital

North Providence, Rhode Island, United States

East Tennessee Brain and Spine

Johnson City, Tennessee, United States

Texas Back Institute

Plano, Texas, United States

San Antonio Orthopedic Group

San Antonio, Texas, United States

South Texas Spine Clinic

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Wyoming Spine and Neurosurgery Associates

Cheyenne, Wyoming, United States

Countries

United States

References

Bailey A, Araghi A, Blumenthal S, Huffmon GV; Anular Repair Clinical Study Group. Prospective, multicenter, randomized, controlled study of anular repair in lumbar discectomy: two-year follow-up. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1161-9. doi: 10.1097/BRS.0b013e31828b2e2f.

Reference Type: DERIVED

PMID: 23392414 (View on PubMed)

Other Identifiers

06101_B

Identifier Type: -

Identifier Source: org_study_id