SciaticaPhase 4NCT00749996
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
A Phase 4 study testing DIAM™ Spinal Stabilization System and Herniectomy in people with Sciatica and Back Pain, run by Medtronic Spinal and Biologics at 19 sites in 8 countries.
Trial summary
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- DIAM™ Spinal Stabilization System and Herniectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Nov 2006to Jun 2013
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification);
- Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year);
- Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale);
- Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette \& Fardon, 2001) as confirmed by MRI at the target level;
- Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001);
- Has an Oswestry Disability Index (ODI) score ≥ 34%;
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- Has been treated non-operatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, hydrotherapy, acupressure/acupuncture, massage, bracing and/or spinal injections) for at least 6 continuous weeks unless strong clinical grounds for expediting surgery;
- Patient male or female, age 20-60 years inclusive and is skeletally mature;
- Is willing and able to comply with the study plan and able to provide an informed consent;
Who cannot join
- Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level;
- Has a symptomatic disc herniation at more than one lumbar level;
- Requires a herniectomy at more than one lumbar level;
- Has a disc degeneration at the treated and adjacent levels > Grade IV (Pfirrmann, 2001);
- Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level;
- Has Modic changes on MRI greater than Grade I at the target level;
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- Has Modic changes on MRI at the adjacent levels;
- Has an advanced degree of retrolisthesis as shown by lateral X-rays (> 25%, i.e. grade I as per Meyerding);
- Has a clinical evidence of lysis, antero listhesis or scoliosis (Cobb angle more than 10°);
- Has signs of segmental instability: more than 4 mm of translation or more than 10° angular motion between adjacent end plates (comparing flexion and extension views);
- Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta);
- Has had any previous lumbar spine surgery;
- Has a Waddell signs of inorganic behaviour score greater than or equal to 3;
- Has evidence of an active disruptive psychiatric disorder, cognitive impairment or other known condition, significant enough to impact the perception of pain, precludes surgical procedure, clinical evaluation and/or ability to evaluate treatment outcome as determined by investigator;
- Has a known allergy to silicone, polyethylene, or titanium;
- Is an alcohol and /or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse;
- Has obesity defined by BMI greater than or equal to 35;
- Inability to complete the questionnaires;
- Planned pregnancy during the course of the study;
- Previous enrollment into a spine study;
- Vulnerable patients or unable to exercise free informed consent;
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Belgium4 sites
Cliniques Universitaires Bruxelles Hôpital Erasme
Brussels
AZ Sint-Lucas
Ghent
Hôpital de la Citadelle
Liège
AZ Sint-Elisabeth Hospital
Zottegem
Germany3 sites
Otto-Von-Guericke Universität
Magdeburg
CA NCH Klinikum rechts der Isar/München
München
Medizinisches Zentrum Kreis Aachen
Würselen
Switzerland3 sites
Hôpital Fribourgeois
Fribourg
Hôpitaux Universitaires de Genève
Geneva
Hirslanden Klinik St. Anna
Lucerne
United Kingdom3 sites
Chase Farm Hospital
Enfield
St. Georges Hospital
London
Greater Manchester Neuroscience Center
Salford
Poland1 site
St. Luke Hospital, University of Rzeszow, dept of Neurosurgery
Tarnów
About this study
Official title: Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.
Read the detailed description
This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups:
Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).
- Being tested
- DIAM™ Spinal Stabilization System, Herniectomy
- Medical subject headings
- Sciatica, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAM™ Spinal Stabilization SystemDevice
The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
HerniectomyProcedure or surgery
Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
| Study group | Role | What they receive |
|---|---|---|
| Investigational group | Experimental | Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System Receives: Device: DIAM™ Spinal Stabilization System |
| Control group | Active comparator | Single level herniectomy Receives: Procedure: Herniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).
The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
Measured: 6 Months
Secondary outcomes (1)
To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).
The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).
The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionApr 2013
- Study completionJun 2013
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 SciaticaStudies 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
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferdiand Krappel, Dr., Principal investigator, Spitalzentrum Oberwallis, Brig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749996
- Sponsor's protocol ID
- DIAM™ Study
- Status last verified
- Jan 2016
- First submitted
- 9 Sep 2008
- Last updated
- 28 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
- ClinicalTrials.gov ID
- NCT00749996
- Acronym / sponsor ID
- DIAM™ Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.
Detailed description
This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups:
Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational group | Experimental | Device: DIAM™ Spinal Stabilization SystemSingle level herniectomy followed by placement of the DIAM™ Spinal Stabilization System |
| Control group | Active comparator | Procedure: HerniectomySingle level herniectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification);
- Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year);
- Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale);
- Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette \& Fardon, 2001) as confirmed by MRI at the target level;
- Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001);
Key exclusion criteria (21 listed)
- Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level;
- Has a symptomatic disc herniation at more than one lumbar level;
- Requires a herniectomy at more than one lumbar level;
- Has a disc degeneration at the treated and adjacent levels > Grade IV (Pfirrmann, 2001);
- Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level;
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 |
|---|---|---|
| DIAM™ Spinal Stabilization SystemThe DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach. | Device | Investigational group |
| HerniectomyHerniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments. | Procedure or surgery | Control group |
Primary outcome
To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).
Time frame: 6 Months
The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
1 secondary outcome
To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ferdiand Krappel, Dr. principal investigator
Spitalzentrum Oberwallis, Brig
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DIAM™ Spinal Stabilization System and Herniectomy in people with Sciatica and Back Pain, run by Medtronic Spinal and Biologics at 19 sites in 8 countries.
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 9 inclusion and 21 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium, Germany, Switzerland, United Kingdom, Italy and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 23 May 2014). 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?
To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS). (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016.