Adjacent Segment DegenerationWallisvsDiamNCT03477955
PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration
A study testing PEEK interspinous spacer in people with Adjacent Segment Degeneration, run by University Hospital of Patras.
Trial summary
A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 49 to 71 years
- Conditions the study is for
- Adjacent Segment Degeneration
- What is being tested?
- PEEK interspinous spacer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Nov 2009
- 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 49 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative MRI with degeneration grades<III at the 1st supradjacent lumbar segment.
Who cannot join
- Body mass index≥40kg/m*m
- Severe osteoporosis
- Lumbar fracture
- Preoperative SVA>4cm
- Spondylolisthesis grades>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation
About this study
Official title: PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.
Read the detailed description
Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.
- Conditions
- Adjacent Segment Degeneration
- Being tested
- PEEK interspinous spacer
- Keywords
- spinopelvic alignment, short lumbosacral instrumentation, PEEK, silicon spacer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK interspinous spacerProcedure or surgery
Also called Silicon interspinous spacer
To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.
| Study group | Role | What they receive |
|---|---|---|
| Peek Group | Active comparator | Patients that received PEEK interspinous spacer Receives: Procedure: PEEK interspinous spacer |
| Silicon Group | Active comparator | Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer Receives: Procedure: PEEK interspinous spacer |
| Control Group | Active comparator | Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer Receives: Procedure: PEEK interspinous spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Oswestry Disability Index scale (0-100)
Measured: Three years
Secondary outcomes (3)
Disc heights
Measured in cm
Measured: Three years
Sacral Slope
Measured in degrees
Measured: Three years
Pain
Visual Analog Scale (0-10)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startApr 2006
- Primary completionApr 2006
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjacent Segment DegenerationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Responsible party
- Principal investigator, Vasileios Syrimpeis, University Hospital of Patras
- Investigators
- Panagiotis Korovessis, PhD, Principal investigator, General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477955
- Sponsor's protocol ID
- WALLIS2018
- Acronym
- WallisvsDiam
- Status last verified
- Apr 2018
- First submitted
- 3 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Korovessis P, Syrimpeis V, Tsekouras V, Vardakastanis K, Fennema P. PEEK versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis. Adv Orthop. 2018 Aug 8;2018:1623647. doi: 10.1155/2018/1623647. eCollection 2018.
PubMed 30174959
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT03477955
- Acronym / sponsor ID
- WallisvsDiam / WALLIS2018
- Conditions
- Adjacent Segment Degeneration
- Keywords
- spinopelvic alignment, short lumbosacral instrumentation, PEEK, silicon spacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Study start
- Apr 2006 (actual)
- Primary completion
- Apr 2006 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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 retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.
Detailed description
Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peek Group | Active comparator | Procedure: PEEK interspinous spacerPatients that received PEEK interspinous spacer |
| Silicon Group | Active comparator | Procedure: PEEK interspinous spacerPatients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer |
| Control Group | Active comparator | Procedure: PEEK interspinous spacerPatients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer |
Who may qualify
- Ages
- 49 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Preoperative MRI with degeneration grades<III at the 1st supradjacent lumbar segment.
Key exclusion criteria (5 listed)
- Body mass index≥40kg/m*m
- Severe osteoporosis
- Lumbar fracture
- Preoperative SVA>4cm
- Spondylolisthesis grades>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation
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 |
|---|---|---|
| PEEK interspinous spacerAlso: Silicon interspinous spacerTo study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers. | Procedure or surgery | Control Group, Peek Group, Silicon Group |
Primary outcome
Quality of Life
Time frame: Three years
Oswestry Disability Index scale (0-100)
3 secondary outcomes
Disc heights
Time frame: Three years
Sacral Slope
Time frame: Three years
Pain
Time frame: Three years
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 10 Apr 2018.
- Derived from this study: PubMed 30174959Korovessis P, Syrimpeis V, Tsekouras V, Vardakastanis K, Fennema P. PEEK versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis. Adv Orthop. 2018 Aug 8;2018:1623647. doi: 10.1155/2018/1623647. eCollection 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Adjacent Segment Degeneration
Not yet recruitingObservational study
Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
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Recruiting
Rehabilitation Exercise Against Complications in High-risk Elderly After Lumbar Fusion(REACH)
Adjacent Segment Degeneration, Multimodal Rehabilitation
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Cervical Arthroplasty Cost Effectiveness Study (CACES)
Radiculopathy, Cervical, Myelopathy Cervical
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Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
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Recruiting
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease
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.
Panagiotis Korovessis, PhD principal investigator
General Hospital of Patras
Questions about this trial
What is this clinical trial studying?
A study testing PEEK interspinous spacer in people with Adjacent Segment Degeneration, run by University Hospital of Patras.
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 1 inclusion and 5 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 10 Apr 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?
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?
Quality of Life (time frame: Three years). 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 NCT03477955, which also lists 1 linked publication.
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 10 Apr 2018.