- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01076244
Vertos Mild - Post Market Patient Outcomes
22 februari 2013 uppdaterad av: The Center for Pain Relief, Inc.
Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.
The patients will be followed for 6 months after the procedure.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks.
Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
Studietyp
Interventionell
Inskrivning (Faktisk)
46
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25301
- The Center for Pain Relief, Inc
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Charleston, West Virginia, Förenta staterna, 25301
- The Center for Pain Relief, Inc.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- Able to walk at least 10 feet unaided before being limited by pain
- Available to complete 26 weeks of follow up
- A signed Consent Form is obtained from the patient
- Adults 18 years of age or older
Exclusion Criteria:
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- Disc protrusion or osteophyte formation severe enough to confound study outcome
- Facet hypertrophy severe enough to confound study outcome
- Bleeding disorders and/or current use of anti-coagulants
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
- Epidural steroids with 3 weeks prior to procedure
- Inability of patient to lie prone for any reason with anesthesia support
- Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
- Dementia and/or inability to give informed consent
- Pregnant and/or breastfeeding
- On workman's Compensation or considering litigation associated with back pain
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Minimally invasive lumbar decompression
|
This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine.
The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring.
Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process.
The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain as Measured by Visual Analog Scale (VAS).
Tidsram: Baseline and six months
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A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain.
The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
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Baseline and six months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement in Functional Mobility
Tidsram: baseline and month 6
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Measured subjectively by the Oswestry Disability Index.
Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity.
The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking.
Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations.
The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
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baseline and month 6
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Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
Tidsram: Baseline and month 6
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As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator.
A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms.
The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value.
Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
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Baseline and month 6
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Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
Tidsram: Baseline and month 6
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For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function.
Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6.
A positive value represents the baseline value minus the 6 month value.
Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.
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Baseline and month 6
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Timothy R Deer, MD, Center for Pain Relief, Inc
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2010
Primärt slutförande (Faktisk)
1 januari 2012
Avslutad studie (Faktisk)
1 januari 2012
Studieregistreringsdatum
Först inskickad
24 februari 2010
Först inskickad som uppfyllde QC-kriterierna
25 februari 2010
Första postat (Uppskatta)
26 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 februari 2013
Senast verifierad
1 februari 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- #D1
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