Lumbar Disc HerniationPhase 4NCT01283438
A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
A Phase 4 study testing Barricaid in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics at 21 sites in 6 countries.
Trial summary
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Barricaid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 17 Dec 2010to Jun 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years old and skeletally mature (male or female).
- Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
- At least six (6) weeks of failed, conservative treatment prior to surgery
- Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
- Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
- Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Who cannot join
- Spondylolisthesis Grade II or higher (25% slip or greater).
- Prior surgery at the index lumbar vertebral level.
- Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- Any metabolic bone disease.
- Subject has insulin-dependent diabetes mellitus.
- Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
Show all 13Show fewer
- Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
- Subject has a known allergy to titanium, polyethylene or polyester materials.
- Any subject that cannot have a baseline MRI taken.
- Subject is pregnant or interested in becoming pregnant in the next three (3) years.
- Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
- Subject is currently involved in another investigational study.
- Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
Germany10 sites
Klinikum Augsburg
Augsburg
Charité - Universitätsmedizin Berlin
Berlin
Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
Bochum, North Rhine-Westphalia, 44892
Klinikum Deggendorf
Deggendorf
Universitätsklinikum Düsseldorf
Düsseldorf
Asklepios Westklinikum Hamburg
Hamburg
UNI Kiel
Kiel
St. Bonifatius Hospital GmbH
Lingen
UMM Mannheim
Mannheim
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, D-18055
Netherlands4 sites
SLAZ Amsterdam
Amsterdam
MCH Antoniushove
Leidschendam
MCH Westeinde
The Hague
Isala Klinieken
Zwolle, 8025AB
Belgium3 sites
OLV Aalst
Aalst
ZNA Middleheim / AZ Klina
Antwerp
AZ Nikolaas
Sint-Niklaas
About this study
Official title: A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.
Read the detailed description
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 \& 10 years for eligible subjects.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Barricaid, Standard of Care
- 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.
BarricaidDevice
Annular closure device
Standard of CareDevice
Standard Limited discectomy
| Study group | Role | What they receive |
|---|---|---|
| Barricaid Device | Experimental | Intervention: Barricaid Device Receives: Device: Barricaid |
| Standard of Care | Active comparator | Standard (Limited) Discectomy Only Receives: Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
To be considered a success, a patient will have achieved success in each of the following outcomes:
- 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op
- 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used)
- Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op
- No deterioration of neurological status at the index level measured by motor function
- Device integrity and lack of implant migration (radiographic, implanted patients only)
- No radiographically confirmed spontaneous fusion
- No radiographically or surgically confirmed reherniation at the index level (on either side)
- No secondary surgical interventions at the index level
Measured: 24 months
No radiographic evidence of recurrent disc herniation
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).
Measured: 24 months
Secondary outcomes (5)
Visual Analog Scale (VAS) Back Pain Improvement
Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on the VAS back at 24 months, relative to baseline.
Measured: 24 months
Oswestry Disability Index (ODI) Improvement
Change in function as measured using the Oswestry Disability Index (ODI). The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability. A subject is a success if there is at least a 15 point improvement (decrease) in the ODI at the 24 month visit relative to baseline.
Measured: 24 months
Reoperation
A subject will be deemed a success if they have not had a second operation at the index level by the 24 month visit. Rates of subject success in treatment and control will be compared at 24 months. A subject is a success if there is at least 75% of the pre-op disc height preserved at the 24 month visit.
Measured: 24 months
Visual Analog Scale (VAS) LEG Pain Improvement
Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on VAS leg pain in the ipsilateral leg at 24 months, relative to baseline.
Measured: 24 months
Disc Height Maintenance
A subject is a success if there is at least 75% of the pre-op disc height preserved as measured on MRI, at the 24 month visit.
Measured: 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 Jan 2011 (estimated)
- Study start17 Dec 2010
- Primary completionOct 2016
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283438
- Sponsor's protocol ID
- EUBARD-CP-011
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2011
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thome C, Klassen PD, Bouma GJ, Kursumovic A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Frohlich S, Wolfs J, Assaker R, Van de Kelft E, Kohler HP, Jadik S, Eustacchio S, Hes R, Martens F; Annular Closure RCT Study Group. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018 Dec;18(12):2278-2287. doi: 10.1016/j.spinee.2018.05.003. Epub 2018 May 3.
PubMed 29730458Martens F, Vajkoczy P, Jadik S, Hegewald A, Stieber J, Hes R. Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial. JB JS Open Access. 2018 Apr 16;3(2):e0037. doi: 10.2106/JBJS.OA.17.00037. eCollection 2018 Jun 28.
PubMed 30280130Klassen PD, Hsu WK, Martens F, Inzana JA, van den Brink WA, Groff MW, Thome C. Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial. Clinicoecon Outcomes Res. 2018 Jun 26;10:349-357. doi: 10.2147/CEOR.S164129. eCollection 2018.
PubMed 29983583Ament J, Thaci B, Yang Z, Kulubya E, Hsu W, Bouma G, Kim KD. Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations. Spine (Phila Pa 1976). 2019 Jan 1;44(1):5-16. doi: 10.1097/BRS.0000000000002746.
PubMed 29927860Kursumovic A, Kienzler JC, Bouma GJ, Bostelmann R, Heggeness M, Thome C, Miller LE, Barth M; Annular Closure RCT study group. Morphology and Clinical Relevance of Vertebral Endplate Changes Following Limited Lumbar Discectomy With or Without Bone-anchored Annular Closure. Spine (Phila Pa 1976). 2018 Oct 15;43(20):1386-1394. doi: 10.1097/BRS.0000000000002632.
PubMed 29538243Klassen PD, Bernstein DT, Kohler HP, Arts MP, Weiner B, Miller LE, Thome C. Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge. J Pain Res. 2017 Aug 26;10:2047-2055. doi: 10.2147/JPR.S144500. eCollection 2017.
PubMed 28894388Thome C, Kursumovic A, Klassen PD, Bouma GJ, Bostelmann R, Martens F, Barth M, Arts M, Miller LE, Vajkoczy P, Hes R, Eustacchio S, Nanda D, Kohler HP, Brenke C, Fluh C, Van de Kelft E, Assaker R, Kienzler JC, Fandino J; Annular Closure RCT Study Group. Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up. JAMA Netw Open. 2021 Dec 1;4(12):e2136809. doi: 10.1001/jamanetworkopen.2021.36809.
PubMed 34882183Kienzler JC, Fandino J, Van de Kelft E, Eustacchio S, Bouma GJ; Barricaid(R) Annular Closure RCT Study Group. Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study. Acta Neurochir (Wien). 2021 Jan;163(1):259-268. doi: 10.1007/s00701-020-04505-4. Epub 2020 Oct 21.
PubMed 33085021van den Brink W, Fluh C, Miller LE, Klassen PD, Bostelmann R. Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial. Medicine (Baltimore). 2019 Nov;98(44):e17760. doi: 10.1097/MD.0000000000017760.
PubMed 31689835Kienzler JC, Klassen PD, Miller LE, Assaker R, Heidecke V, Frohlich S, Thome C; Annular Closure RCT Study Group. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir (Wien). 2019 Jul;161(7):1389-1396. doi: 10.1007/s00701-019-03948-8. Epub 2019 May 15.
PubMed 31089894
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors
- ClinicalTrials.gov ID
- NCT01283438
- Acronym / sponsor ID
- EUBARD-CP-011
- Conditions
- Lumbar Disc Herniation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2010 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Jan 2011 (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.
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.
Detailed description
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 \& 10 years for eligible subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barricaid Device | Experimental | Device: BarricaidIntervention: Barricaid Device |
| Standard of Care | Active comparator | Device: Standard of CareStandard (Limited) Discectomy Only |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21 to 75 years old and skeletally mature (male or female).
- Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
- At least six (6) weeks of failed, conservative treatment prior to surgery
- Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
- Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
Key exclusion criteria (13 listed)
- Spondylolisthesis Grade II or higher (25% slip or greater).
- Prior surgery at the index lumbar vertebral level.
- Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- Any metabolic bone disease.
- Subject has insulin-dependent diabetes mellitus.
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 |
|---|---|---|
| BarricaidAnnular closure device | Device | Barricaid Device |
| Standard of CareStandard Limited discectomy | Device | Standard of Care |
Primary outcome
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
Time frame: 24 months
To be considered a success, a patient will have achieved success in each of the following outcomes: * 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op * 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used) * Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op * No deterioration of neurological status at the index level measured by motor function * Device integrity and lack of implant migration (radiographic, implanted patients only) * No radiographically confirmed spontaneous fusion * No radiographically or surgically confirmed reherniation at the index level (on either side) * No secondary surgical interventions at the index level
No radiographic evidence of recurrent disc herniation
Time frame: 24 months
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).
5 secondary outcomes
Visual Analog Scale (VAS) Back Pain Improvement
Time frame: 24 months
Oswestry Disability Index (ODI) Improvement
Time frame: 24 months
Reoperation
Time frame: 24 months
Visual Analog Scale (VAS) LEG Pain Improvement
Time frame: 24 months
Disc Height Maintenance
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 29730458Thome C, Klassen PD, Bouma GJ, Kursumovic A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Frohlich S, Wolfs J, Assaker R, Van de Kelft E, Kohler HP, Jadik S, Eustacchio S, Hes R, Martens F; Annular Closure RCT Study Group. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018 Dec;18(12):2278-2287. doi: 10.1016/j.spinee.2018.05.003. Epub 2018 May 3.
- Results publication: PubMed 30280130Martens F, Vajkoczy P, Jadik S, Hegewald A, Stieber J, Hes R. Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial. JB JS Open Access. 2018 Apr 16;3(2):e0037. doi: 10.2106/JBJS.OA.17.00037. eCollection 2018 Jun 28.
- Results publication: PubMed 29983583Klassen PD, Hsu WK, Martens F, Inzana JA, van den Brink WA, Groff MW, Thome C. Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial. Clinicoecon Outcomes Res. 2018 Jun 26;10:349-357. doi: 10.2147/CEOR.S164129. eCollection 2018.
- Results publication: PubMed 29927860Ament J, Thaci B, Yang Z, Kulubya E, Hsu W, Bouma G, Kim KD. Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations. Spine (Phila Pa 1976). 2019 Jan 1;44(1):5-16. doi: 10.1097/BRS.0000000000002746.
- Results publication: PubMed 29538243Kursumovic A, Kienzler JC, Bouma GJ, Bostelmann R, Heggeness M, Thome C, Miller LE, Barth M; Annular Closure RCT study group. Morphology and Clinical Relevance of Vertebral Endplate Changes Following Limited Lumbar Discectomy With or Without Bone-anchored Annular Closure. Spine (Phila Pa 1976). 2018 Oct 15;43(20):1386-1394. doi: 10.1097/BRS.0000000000002632.
- Results publication: PubMed 28894388Klassen PD, Bernstein DT, Kohler HP, Arts MP, Weiner B, Miller LE, Thome C. Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge. J Pain Res. 2017 Aug 26;10:2047-2055. doi: 10.2147/JPR.S144500. eCollection 2017.
- Derived from this study: PubMed 34882183Thome C, Kursumovic A, Klassen PD, Bouma GJ, Bostelmann R, Martens F, Barth M, Arts M, Miller LE, Vajkoczy P, Hes R, Eustacchio S, Nanda D, Kohler HP, Brenke C, Fluh C, Van de Kelft E, Assaker R, Kienzler JC, Fandino J; Annular Closure RCT Study Group. Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up. JAMA Netw Open. 2021 Dec 1;4(12):e2136809. doi: 10.1001/jamanetworkopen.2021.36809.
- Derived from this study: PubMed 33085021Kienzler JC, Fandino J, Van de Kelft E, Eustacchio S, Bouma GJ; Barricaid(R) Annular Closure RCT Study Group. Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study. Acta Neurochir (Wien). 2021 Jan;163(1):259-268. doi: 10.1007/s00701-020-04505-4. Epub 2020 Oct 21.
- Derived from this study: PubMed 31689835van den Brink W, Fluh C, Miller LE, Klassen PD, Bostelmann R. Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial. Medicine (Baltimore). 2019 Nov;98(44):e17760. doi: 10.1097/MD.0000000000017760.
- Derived from this study: PubMed 31089894Kienzler JC, Klassen PD, Miller LE, Assaker R, Heidecke V, Frohlich S, Thome C; Annular Closure RCT Study Group. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir (Wien). 2019 Jul;161(7):1389-1396. doi: 10.1007/s00701-019-03948-8. Epub 2019 May 15.
- Sponsor websiteLink provided by the sponsor.
- Published protocol design manuscriptLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Barricaid in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics at 21 sites in 6 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Netherlands, Belgium, Austria, France and 1 more country. 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?
Results are not available in the source record.
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?
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT01283438, which also lists 10 linked publications.
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 Sep 2023.