Lumbar Degenerative Disc DiseaseATBNCT01323387

Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer

A study testing Interbody Fusion in people with Lumbar Degenerative Disc Disease, run by Synthes USA HQ, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years. The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lumbar Degenerative Disc Disease
What is being tested?: Interbody Fusion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: No sites listed yet
Study dates: 1 Apr 2004to 1 Feb 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:
Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:
Modic type 2 endplate changes on T2 weighted MRI
high intensity zone signal on T2 weighted MRI
positive discogram with negative controls
dark disc (diminished T2 weighted signal)

Show all 12Show fewer

decreased disc height
Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
Skeletally mature and at least 18 years of age
Signs the approved Informed Consent Document
Is available for long term follow-up and interval visits

Who cannot join

Has more than 2 levels to be instrumented
Has had a previous fusion attempt at the involved level(s)
Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
Currently implanted with anterior instrumentation at the involved level(s)
Patient would be classified as morbidly obese BMI > 35
Active localized or systemic infection

Show all 12Show fewer

Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.)
Has an immunosuppressive disorder
Pregnant or interested in becoming pregnant during the study.
Has a known sensitivity to device materials
Mentally incompetent or prisoner
Currently a participant in another study for the same indications.

About this study

Official title: Lumbar Degenerative Disc Disease Treated With

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.

The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.

Conditions: Lumbar Degenerative Disc Disease
Being tested: Interbody Fusion
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interbody FusionDevice
Also called ATB, Anterior Tension Band
allograft spacer + anterior plate

Study groups in NCT01323387
Study group	Role	What they receive
Treatment	Other	Interbody fusions with Anterior Plating Receives: Device: Interbody Fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Successful Radiographic Fusion
CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
Measured: 24 Months

Secondary outcomes (7)

Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.
Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.
Measured: 24 Months
Pain Scores on the Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)
Measured: Baseline and 24 Months
Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Measured: 24 Months
Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Measured: Baseline and 24 Months
SF-12 Physical Composite Score (PCS) Summary
The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Measured: Baseline and 24 Months
SF-12 Mental Composite Score (MCS) Summary
The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Measured: Baseline and 24 Months
Oswestry Disability Index (ODI) Summary
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Measured: Baseline and 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20041 Feb 2011

First posted25 Mar 2011 (estimated)
Study start1 Apr 2004
Primary completion1 May 2009
Study completion1 Feb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Degenerative Disc DiseaseStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323387
Sponsor's protocol ID: 1255
Acronym: ATB
Status last verified: Dec 2017
First submitted: 23 Mar 2011
Last updated: 16 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

All Lumbar Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lumbar Degenerative Disc Disease Treated With
ClinicalTrials.gov ID: NCT01323387
Acronym / sponsor ID: ATB / 1255
Conditions: Lumbar Degenerative Disc Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2004 (actual)
Primary completion: 1 May 2009 (actual)
Study completion: 1 Feb 2011 (actual)
First posted: 25 Mar 2011 (estimated)
Results: Posted 17 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Device: Interbody FusionInterbody fusions with Anterior Plating

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:
Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:
Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
Skeletally mature and at least 18 years of age

Key exclusion criteria (12 listed)

Has more than 2 levels to be instrumented
Has had a previous fusion attempt at the involved level(s)
Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
Currently implanted with anterior instrumentation at the involved level(s)
Patient would be classified as morbidly obese BMI > 35

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
Interbody FusionAlso: ATB, Anterior Tension Bandallograft spacer + anterior plate	Device	Treatment

Primary outcome

Number of Subjects With Successful Radiographic Fusion
Time frame: 24 Months
CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.

7 secondary outcomes

Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.
Time frame: 24 Months
Pain Scores on the Numeric Rating Scale (NRS)
Time frame: Baseline and 24 Months
Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
Time frame: 24 Months
Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
Time frame: Baseline and 24 Months
SF-12 Physical Composite Score (PCS) Summary
Time frame: Baseline and 24 Months
SF-12 Mental Composite Score (MCS) Summary
Time frame: Baseline and 24 Months
Oswestry Disability Index (ODI) Summary
Time frame: Baseline and 24 Months

Results and safety

Results posted to the registry on 17 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	178	94

Primary outcome: Number of Subjects With Successful Radiographic Fusion

Time frame: 24 Months. Count of participants. Unit: Participants

Measure	Treatment n = 94
Value	90

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	19 of 150 (12.7%)	77 of 150 (51.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Degenerative Disc Disease

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

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.

Kirkham Wood, MD principal investigator

Massachusetts General Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Interbody Fusion in people with Lumbar Degenerative Disc Disease, run by Synthes USA HQ, Inc..

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 12 inclusion and 12 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 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Successful Radiographic Fusion (time frame: 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 NCT01323387.

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 16 Jan 2018.