A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Degenerative Lumbar Spine Causing Back and/or Leg Pain · Lumbar Spine Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01143324 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MAST™ procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Spinal and Biologics
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Surgery to First Ambulation. |
1.3 | — |
| PRIMARY Time to Surgery Recovery Day. |
3.2 | — |
| SECONDARY Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline. |
6.2; 2.9 | <0.0001 sig |
| SECONDARY Leg Pain Intensity VAS Score as Compared to Baseline |
5.9; 2.2 | <0.0001 sig |
| SECONDARY EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline. |
0.34; 0.71 | <0.0001 sig |
| SECONDARY Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care. |
118; 43 | — |
| SECONDARY Number of Patients Who Utilized Rehabilitation Programs |
61 | — |
| SECONDARY Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates). |
3 | — |
| SECONDARY Proportion of Patients Needing Intervention at Adjacent Level(s). |
4 | — |
| SECONDARY Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline. |
185; 107 | — |
| SECONDARY Document Adverse Events Occurrence Throughout the Study. |
125 | — |
| SECONDARY ODI Difference 12 Months After the Surgery as Compared to Baseline. |
45.5; 22.4 | <0.0001 sig |
| SECONDARY Number of Patients That Returned to Work 12months After the Surgery. |
79; 97 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Patient is >18 years of age (or minimum age as required by local regulations).
- Patient has indication for a single or double level instrumented lumbar fusion for the treatment of the degenerative lumbar spine.
- Patient agrees to participate in the study and is able to sign the Data Release Form/Informed Consent.
- The procedure planned for the patient complies with the labeling of the Devices that may be used in the surgical procedure as described in the section B.2 Device Information.
- Patient is planned to be submitted to the fusion procedure using PLIF or TLIF techniques and to receive a CD HORIZON® Spinal System via a MAST™ approach.
- The patient is willing and is able to cooperate with study procedures and required follow-up visits.
Exclusion Criteria
- Patient that has already undergone an open lumbar spine surgery other than microdiscectomy.
- Indications for the procedure other than degenerative spine disease like Osteoporotic vertebral fractures, Spine trauma fractures and Spine tumor.
In order to reduce as much as possible bias in this observational study, the study centers should propose the study to all consecutive individuals who meet these in and exclusion criteria to participate in the study in order to comply with the 'real world' population concept. This observational study does not require any specific test or procedure that falls outside a standard surgical procedure and patient follow-up as routinely done in the hospital. Some data was collected only for centers that applied such procedures as standard of care.
Data sourced from ClinicalTrials.gov (NCT01143324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.