A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusi… (NCT01143324) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
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 Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.
Who can participate
Age range18 Years
SexALL
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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. S…
What they're measuring
1
Time From Surgery to First Ambulation.
Timeframe: From date of Surgery to date of First ambulation, assessed up to hospital discharge.
2
Time to Surgery Recovery Day.
Timeframe: From date of surgery until date of surgery recovery day assessed up to hospital discharge.