Status:
COMPLETED
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Lumbar Spine Causing Back and/or Leg Pain
Lumbar Spine Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar In...
Detailed Description
Instrumented lumbar fusion is usually done through an open procedure which involves an excessive intraoperative dissection and retraction of the paraspinal musculature leading, in a short term basis, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01143324
Start Date
June 1 2010
End Date
August 1 2013
Last Update
January 8 2019
Active Locations (19)
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1
Klinikum Amstetten
Amstetten, Austria
2
OLV Ziekenhuis
Aalst, Belgium
3
Spine, Sports Medicine and Orthopedic Surgery
Saint John, New Brunswick, Canada
4
Karvinska Hornicka Nemocnice
Fryštát, Czechia