Degenerative Disc DiseaseNCT01850537
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
A study testing treatment of degenerative disc disease using the PROW LIF in people with Degenerative Disc Disease, run by NLT Spine at 1 site in Israel.
Trial summary
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- treatment of degenerative disc disease using the PROW LIF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between 18-65 years of age (skeletally mature).
- Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:
- instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
- osteophyte formation;
- decreased disc height;
- ligamentous thickening;
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- disc degeneration/herniation; or
- facet joint degeneration.
- A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
- Be non-responsive to non-operative treatment for at least 6 months;
- -
Who cannot join
- The Antero-Posterior (AP) diameter (at midline) of the involved level is <31mm.
- Any previous spinal surgery at the involved level;
- Spondylolisthesis > grade I;
- Ankylosed segment at the affected level;
- History or radiographic evidence of osteoporotic fractures in the spine;
- Paraparesis;
- Progressive neurologic conditions;
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Spine Surgery Department, Meir Hospital, Israel
Kfar Saba
Joseph Leitner, MD Dr., +972- 97472590, leitner@clalit.org.il
Joseph Leitner, MD Dr.
About this study
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
Read the detailed description
Primary endpoints:
- Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded.
- Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.
- Conditions
- Degenerative Disc Disease
- Being tested
- treatment of degenerative disc disease using the PROW LIF
- Keywords
- DDD, PROW, FUSION, eSPIN, Cage, IBF, Discectomy, Lumbar Fusion, TLIF, MIS
- 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.
treatment of degenerative disc disease using the PROW LIFDevice
Also called PROW LIF Procedure
TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | treatment of degenerative disc disease using the PROW LIF Receives: Device: treatment of degenerative disc disease using the PROW LIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
Primary radiographic effectiveness outcome parameter: evaluations of fusion. Fusion will be evaluated at 6 months, 12 months and 24 months post-op using plain radiographs (AP, lateral and flexion/extension films) and at 24 months using CT scan as well
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NLT Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Leitner, MD Dr., Principal investigator, Head of the Spine surgery department, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850537
- Sponsor's protocol ID
- CLN0171
- Status last verified
- May 2013
- First submitted
- 30 Apr 2013
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
- ClinicalTrials.gov ID
- NCT01850537
- Acronym / sponsor ID
- CLN0171
- Conditions
- Degenerative Disc Disease
- Keywords
- DDD, PROW, FUSION, eSPIN, Cage, IBF, Discectomy, Lumbar Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NLT SpineIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 May 2013 (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.
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
Detailed description
Primary endpoints:
- Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded.
- Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Device: treatment of degenerative disc disease using the PROW LIFtreatment of degenerative disc disease using the PROW LIF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female between 18-65 years of age (skeletally mature).
- Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:
- A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
- Be non-responsive to non-operative treatment for at least 6 months;
- -
Key exclusion criteria (8 listed)
- The Antero-Posterior (AP) diameter (at midline) of the involved level is <31mm.
- Any previous spinal surgery at the involved level;
- Spondylolisthesis > grade I;
- Ankylosed segment at the affected level;
- History or radiographic evidence of osteoporotic fractures in the spine;
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 |
|---|---|---|
| treatment of degenerative disc disease using the PROW LIFAlso: PROW LIF ProcedureTLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system) | Device | single arm study |
Primary outcome
Fusion rate
Time frame: 24 months follow up
Primary radiographic effectiveness outcome parameter: evaluations of fusion. Fusion will be evaluated at 6 months, 12 months and 24 months post-op using plain radiographs (AP, lateral and flexion/extension films) and at 24 months using CT scan as well
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
- NLT SPINE websiteLink 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.
Joseph Leitner, MD Dr. principal investigator
Head of the Spine surgery department, Meir Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment of degenerative disc disease using the PROW LIF in people with Degenerative Disc Disease, run by NLT Spine at 1 site in Israel.
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 11 inclusion and 8 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 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josef Leitner, MD DR. (+972-9-7472590, leitner@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (time frame: 24 months follow up). 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 9 May 2013.