Chronic Low Back PainNCT02203448
Facet Wedge Post Market Study
An observational study of Chronic Low Back Pain and Degenerative Disc Disease, run by Synthes GmbH at 3 sites in 2 countries.
Trial summary
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease
- What is being tested?
- Facet Wedge spinal system
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 May 2014to 31 Aug 2018
- Phase
- Observational
- 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
Study population: The cases in the cohort are selected from patients treated in hospitals.
Who may be able to join
- Subjects diagnosed with at least one of the following:
- Degenerative Disc Disease (DDD);
- Degenerative facet joint disease (isolated facet based symptomatic back pain);
- Pseudoarthrosis post anterior instrumentation;
- Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
- Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Who cannot join
- Preoperative exclusion criteria:
- Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
- Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
- Compromised facets due to decompression techniques;
- Spondylolisthesis;
- Fracture or other instabilities of the posterior elements;
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- Tumor;
- Acute or chronic systemic or localized spinal infections;
- Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
- Subjects aged below 18 years;
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation;
- Intraoperative exclusion criteria:
- Intraoperative decision to use implants other than the device under investigation.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
BG Unfallklinik
Frankfurt am Main, 60439
Schon Klinik Munchen
München, 81547
About this study
Official title: A Multi-centre, Prospective, Single-arm Post Market Clinical Follow up Study (PMCF) of the FACET WEDGE Spinal System to Assess Outcomes in Subjects With Chronic Low Back Pain Due to Degenerative Disc Disease (DDD), Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.
The primary objective of this study is to determine the rate of re-operations at the index level(s).
The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease, Pseudo Arthrosis Post Anterior Instrumentation
- Being tested
- Facet Wedge spinal system
- 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.
Facet Wedge spinal systemDevice
| Study group | Role | What they receive |
|---|---|---|
| FACET WEDGE spinal system | The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions. Receives: Device: Facet Wedge spinal system |
What is being measured
The primary outcome is the main question the study is designed to answer.
reoperation rate at the index level(s)
Measured: at two years
Secondary outcomes (4)
the radiographic range of motion (ROM) at the index levels
Measured: Pre-treatment, 6 months, 12 months, 24 months
patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
Measured: pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.
functional success based on results from the Oswestry Disability Index (ODI)
Measured: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
Adverse events
The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start1 May 2014
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Kandziora, PhD, Principal investigator, Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203448
- Sponsor's protocol ID
- CT13/01
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2014
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Single-arm Post Market Clinical Follow up Study (PMCF) of the FACET WEDGE Spinal System to Assess Outcomes in Subjects With Chronic Low Back Pain Due to Degenerative Disc Disease (DDD), Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation
- ClinicalTrials.gov ID
- NCT02203448
- Acronym / sponsor ID
- CT13/01
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease, Pseudo Arthrosis Post Anterior Instrumentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 30 Jul 2014 (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 Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.
The primary objective of this study is to determine the rate of re-operations at the index level(s).
The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FACET WEDGE spinal system | – | Device: Facet Wedge spinal systemThe FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cases in the cohort are selected from patients treated in hospitals.
Key inclusion criteria (6 listed)
- Subjects diagnosed with at least one of the following:
- Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
- Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Key exclusion criteria (13 listed)
- Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
- Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
- Compromised facets due to decompression techniques;
- Spondylolisthesis;
- Fracture or other instabilities of the posterior elements;
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 |
|---|---|---|
| Facet Wedge spinal system | Device | FACET WEDGE spinal system |
Primary outcome
reoperation rate at the index level(s)
Time frame: at two years
4 secondary outcomes
the radiographic range of motion (ROM) at the index levels
Time frame: Pre-treatment, 6 months, 12 months, 24 months
patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
Time frame: pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.
functional success based on results from the Oswestry Disability Index (ODI)
Time frame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
Adverse events
Time frame: Throughout the study
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 19 Oct 2018.
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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.
Frank Kandziora, PhD principal investigator
Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Degenerative Disc Disease, run by Synthes GmbH at 3 sites in 2 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: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Slovakia. 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.
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?
reoperation rate at the index level(s) (time frame: at two years). 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 19 Oct 2018.