DiskectomyPhase 4NCT00760799
Randomized Study of Anular Repair With the Xclose Tissue Repair System
A Phase 4 study testing Discectomy with anular repair in people with Diskectomy, run by Anulex Technologies, Inc. at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diskectomy
- What is being tested?
- Discectomy with anular repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 34 sitesUnited States
- Study dates
- Mar 2007to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
New England Baptist
Boston, Massachusetts, 02120
Wyoming Spine and Neurosurgery Associates
Cheyenne, Wyoming, 82009
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Chicago Institute of Neurosurgery and Neuroresearch
Chicago, Illinois, 60640
Oakwood Hospital
Dearborn, Michigan, 48124
Henry Ford
Detroit, Michigan, 48202
North Florida Regional Hospital
Gainesville, Florida, 32605
Denver Spine (Porter Hospital)
Greenwood Village, Colorado, 80111
Denver Spine (Presbyterian/St. Luke's Hospital)
Greenwood Village, Colorado, 80111
Pennsylvania Spine Institute
Harrisburg, Pennsylvania, 17109
North Alabama Neurological, P.A.
Huntsville, Alabama, 35801
Indiana Spine Group
Indianapolis, Indiana, 46260
Lyerly Neurosurgical (Baptist Health)
Jacksonville, Florida, 32207
Mayo Clinic
Jacksonville, Florida, 32224
Lyerly Neurosurgical (Centerone)
Jacksonville, Florida, 32256
East Tennessee Brain and Spine
Johnson City, Tennessee, 37604
University of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Our Lady of Fatima Hospital
North Providence, Rhode Island, 02904
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2035
Heartland Spine
Overland Park, Kansas, 66211
Palos Community Hospital
Palos Heights, Illinois, 60463
Texas Back Institute
Phoenix, Arizona, 85015
Desert Institute for Spine Care
Phoenix, Arizona, 85020
West Penn Neurosurgery Group
Pittsburgh, Pennsylvania, 15232
Texas Back Institute
Plano, Texas, 75093
Capital Neurosurgery
Raleigh, North Carolina, 27609
University of Utah
Salt Lake City, Utah, 84112
San Antonio Orthopedic Group
San Antonio, Texas, 75216
South Texas Spine Clinic
San Antonio, Texas, 75258
University of California San Diego
San Diego, California, 92103
Central Minnesota Neurosciences
Sartell, Minnesota, 56377
Hudson Valley Neurosurgical Associates
Suffern, New York, 10901
Atlantic Neurosurgical & Spine
Wilmington, North Carolina, 28401-7593
About this study
The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.
Read the 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
- Being tested
- Discectomy with anular repair
- Keywords
- Lumbar Disc Herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discectomy with anular repairProcedure or surgery
Also called Repair of the anulus fibrosus following discectomy.
Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard discectomy without anular repair Receives: Procedure: Discectomy with anular repair |
| 2 | Experimental | Standard Discectomy with anular repair Receives: Procedure: Discectomy with anular repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operations due to re-herniation (repeat discectomy procedure)
Measured: 2 wks and at 6, 12, 18 and 24 months
Secondary outcomes (1)
Patient outcomes (utilizing Oswestry Disability Index, Visual Analog Scale and SF-12 quality of life assessment), Health care utilization, Return to work
Measured: 2 weeks and at 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiskectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anulex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760799
- Sponsor's protocol ID
- 06101_B
- Status last verified
- May 2012
- First submitted
- 25 Sep 2008
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23392414
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Anular Repair With the Xclose Tissue Repair System
- ClinicalTrials.gov ID
- NCT00760799
- Acronym / sponsor ID
- 06101_B
- Conditions
- Diskectomy
- Keywords
- Lumbar Disc Herniation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Anulex Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Discectomy with anular repairStandard discectomy without anular repair |
| 2 | Experimental | Procedure: Discectomy with anular repairStandard Discectomy with anular repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discectomy with anular repairAlso: Repair of the anulus fibrosus following discectomy.Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc | Procedure or surgery | 1, 2 |
Primary outcome
Re-operations due to re-herniation (repeat discectomy procedure)
Time frame: 2 wks and at 6, 12, 18 and 24 months
1 secondary outcome
Patient outcomes (utilizing Oswestry Disability Index, Visual Analog Scale and SF-12 quality of life assessment), Health care utilization, Return to work
Time frame: 2 weeks and at 6, 12, 18, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
- Derived from this study: PubMed 23392414Bailey 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.
Related trials for Diskectomy
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Not yet recruitingObservational study
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
ACDF Surgery
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Not yet recruiting
Rehabilitation After Anterior Cervical Discectomy and Fusion
Cervical Disc Disease, Cervical Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discectomy with anular repair in people with Diskectomy, run by Anulex Technologies, Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operations due to re-herniation (repeat discectomy procedure) (time frame: 2 wks and at 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.