Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lumbar spinal arthroplasty + Maverick™ | Patients requiring total disc replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar spinal arthroplasty + Maverick™ | Procedure | All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS) | Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced. 0 = no pain, 10 = worst possible pain | 6 months |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Patient eligibility is determined according to labeling
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles Le Huec, Prof. | CHU Pellegrin Tripode | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Québec | H3G1A4 | Canada | |||
| CHU Pellegrin Tripode |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lumbar Spinal Arthroplasty + Maverick™ | Patients requiring total disc replacement lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled |
|
| |||||||||||||||||||||
| Implant |
| ||||||||||||||||||||||
| Discharge |
| ||||||||||||||||||||||
| 6 Months Follow up |
| ||||||||||||||||||||||
| 12 Months Follow up |
| ||||||||||||||||||||||
| 24 Months Follow up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lumbar Spinal Arthroplasty + Maverick™ | Patients requiring total disc replacement lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'. | Reduction of disability was calculated for patients having available data at both baseline and 6 months. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumbar Spinal Arthroplasty + Maverick™ | Patients requiring total disc replacement lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal wall related | General disorders |
Not provided
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. All events are here-reported as SAEs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Faria | Medtronic Spinal & Biologics | +41 (0)21 802 70 00 | cristina.faria@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bordeaux |
| 33076 |
| France |
| CH Antoine Béclère - Service de Chirurgie Orthopédique | Clamart | 92141 | France |
| Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon | Clichy | 92110 | France |
| Clinique de Neurochirurgie Hôpital Roger Salengro | Lille | 59037 | France |
| CH La Timone | Marseille | 13385 | France |
| CH de Meulan - Service de Chirurgie Orthopédique | Meulan-en-Yvelines | 78250 | France |
| Service de Neurochirurgie Hôpital Nice | Nice | 06300 | France |
| CH Lariboisière, Service de Neurochirurgie | Paris | 75010 | France |
| Clinique du Cours Dillon | Toulouse | 31300 | France |
| Charité Berlin - Klinik für Orthopädie | Berlin | 10117 | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | 39120 | Germany |
| Praxis für Orthopädie und Neurochirurgie Potsdam | Potsdam | 14482 | Germany |
|
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS) | Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced. 0 = no pain, 10 = worst possible pain | Reduction of disability was calculated for patients having available data at both baseline and 6 months. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
|
| 57 |
| 134 |
| 0 |
| 134 |
| Neurologic - Access-related | Nervous system disorders |
|
| Neurologic - Late radiculopathy (not access-related) | Nervous system disorders |
|
| Vascular | Vascular disorders |
|
| Visceral - Bowel or Peritoneum | General disorders |
|
| Visceral - Genito-Urinary tract | General disorders |
|
| Subsidence / Impaction | Musculoskeletal and connective tissue disorders |
|
| Early non-specific low BP | General disorders |
|
| Late non-specific low BP | General disorders |
|
| Foreign body reaction | Immune system disorders |
|
| Other events | General disorders |
|
Confidential Information shall not be disclosed and shall be property of sponsor during the term of the agreement and for 3 years after agreement termination. Results might be published or presented, however sponsor should receive publication for review at least 90 days prior to submittal. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed, to allow sponsor to protect its rights in copyrightable material, and to check for technical correctness.