- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01652053
A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy
A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Laurie E Lynch, PhD
- Telefonnummer: 952-221-2468
- E-Mail: laurie.lynch@visi.com
Studieren Sie die Kontaktsicherung
- Name: Felt Jeff, MD
- Telefonnummer: 612-708-4838
- E-Mail: jfelt@vti-spine.com
Studienorte
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Manitoba
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Brandon, Manitoba, Kanada, R7A 2B3
- Rekrutierung
- Brandon Regional Health Center
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Kontakt:
- Jeff Felt, MD
- Telefonnummer: 612-708-4838
- E-Mail: jfelt@vti-spine.com
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Kontakt:
- Ben A. Wasscher, MBA
- Telefonnummer: 763-218-4311
- E-Mail: bwasscher@vti-spine.com
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Hauptermittler:
- Phillip de Mueleneare, MD
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patient has signed and dated a study specific informed consent form approved by the reviewing Institutional Review Board or Ethics Committee.
- Patient is 21 to 60 years of age.
- Patient is skeletally mature
- Patient requires a discectomy of one level from L2-S1.
- Patient has less than 50% loss of disc height at the affected level.
- Patient has persistent pain (predominantly leg pain, although some back pain that occurred at the same time as the leg pain and is believed to be associated with the disc herniation will not disqualify the patient from participating in this study) and symptoms despite a minimum of six weeks of non-operative treatment.
- Patient X-ray, CT or MR evidence of a herniated disc at the affected level.
- Patient has a minimum leg pain score of 6 cm on a 10 cm (i.e. 60 mm on a 100 mm) point visual analog scale (VAS).
- Patient has a minimum Oswestry Disability Index score of 40% (based upon a 100% scale).
- Patient is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
- Patient has had any previous surgery at the affected levels.
- Patient has had any attempt at spinal fusion, at any lumbar levels.
- Patient has motion of < 3 degrees on pre-operative lateral flexion/extension radiographs
- Patient has a BMI
- Patient has severe osteoporosis of the spine.
- Patient has previously undergone chemotherapy, immunosuppressive therapy or radiation to the local area.
- Patient has active local or systemic infection.
- Patient has any known active malignancy.
- Patient has rheumatoid arthritis or systemic lupus erythematosus, or other chronic, inflammatory autoimmune disorder.
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has spondylolisthesis.
- Patient is pregnant or plans to become pregnant during the course of the study.
- Patient has other concurrent physical or mental conditions that are likely to affect their outcome.
- Patient has congenital stenosis
- Patient is diabetic.
- The patient has osteoporosis or severe osteopenia as determined by the Investigator. Females over 40 with bone density score less than -1. A clinical SCORE calculator may also be utilized for females over 40 years of age.
- Patient has significant facet disease.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Disc Nucleus Replacement
Disc Nucleus Replacement (InterCushion DNP)
|
The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1.
These patients should have no spondylolisthesis at the involved level.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Decrease in ODI
Zeitfenster: 6 months
|
Improvement in the Oswestry Disability Index (ODI) score i.e. decrease of 15% or better ODI.
|
6 months
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Decrease in VAS
Zeitfenster: 6 months
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Improvement in leg pain evidenced by decrease in pain score of at least 2 cm (i.e.
20 mm) on the visual analog scale (VAS)
|
6 months
|
Maintenance of post-operative disc height
Zeitfenster: 6 months
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Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.
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6 months
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Mobility of treated segment
Zeitfenster: 6 months
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Motion of ≥ 3 degrees on lateral flexion/extension radiographs
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6 months
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Neurologic deficits
Zeitfenster: 6 months
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No new permanent neurological deficit or worsening of an existing permanent neurological deficit
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6 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Maintenance or decrease in ODI
Zeitfenster: 12 and 24 months
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Maintenance of improvement or further improvement in the Oswestry Disability Index (ODI) score measured at six months i.e. decrease of 15% or better ODI.
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12 and 24 months
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Maintenance or decrease in VAS
Zeitfenster: 12 and 24 months
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Maintenance of improvement or further improvement in leg pain evidenced by decrease in pain score on the visual analog scale (VAS)
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12 and 24 months
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Maintenance of post-operative disc height.
Zeitfenster: 12 and 24 months
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Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.
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12 and 24 months
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Mobility of treated segment
Zeitfenster: 12 and 24 months
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Motion of ≥ 3 degrees on lateral flexion/extension radiographs
|
12 and 24 months
|
Neurological deficits
Zeitfenster: 12 and 24 months
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No new permanent neurological deficit or worsening of an existing permanent neurological deficit
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12 and 24 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Failures
Zeitfenster: 6, 12 and 24 months
|
Revision: is a procedure that adjusts or in any way modifies or removes part of the original implant configuration, with or without replacement of a component. Removal: is a procedure where the entire original system configuration is removed with or without replacement. Supplemental fixation: a procedure in which additional instrumentation not under study is implanted. |
6, 12 and 24 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Phillip F de Muelanaere, MD, Brandon General Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CP 2010-001
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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