A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

NCT ID: NCT01143324

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 255 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-08-31

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 Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

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, to a prolonged recovery time from the surgery. This open approach is frequently associated with significant blood loss and need of transfusion, produces the majority of the perioperative pain, increases hospital stay and the chances of infection and delays the return to normal activities and to work. In a long term basis, the open procedure leads to denervation, atrophy and loss of the muscles independent function, resulting in an increased risk of "fusion disease", a term that has been coined to describe its occurrence.

The minimally invasive spinal surgery was developed as a potential solution to the above-mentioned problems by reducing the amount of iatrogenic soft tissue injury while reaching the same traditional goals of the open procedures. Besides minimizing the long-term effects of exposure-related muscle injury, minimally invasive lumbar fusion techniques hold the promise of immediate short-term advantages. Patients undergoing minimally invasive procedures are reported to recover earlier from the surgery. Shorter time to first ambulation, less pain medication consumption, less blood loss, less required transfusion, shorter hospital stay and earlier return to work are generally associated with the minimally invasive procedure as compared to the standard open surgeries. The minimally invasive access requires a surgical corridor targeted on the disease which is accomplished by using a series of tubular muscle dilators allowing a clear intraoperative visualization to perform these procedures together with the parallel use of image guided percutaneous insertion of pedicle screws and instrumentation.

The purpose of this study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF or TLIF techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

Conditions

Degenerative Lumbar Spine Causing Back and/or Leg Pain; Lumbar Spine Degeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

MAST™ procedure

MAST™ procedure

Intervention Type: DEVICE

Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.

Interventions

MAST™ procedure

Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörg Franke, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Wirbelsäulenchirurgie; Dortmund

Locations

Klinikum Amstetten

Amstetten, , Austria

OLV Ziekenhuis

Aalst, , Belgium

Spine, Sports Medicine and Orthopedic Surgery

Saint John, New Brunswick, Canada

Karvinska Hornicka Nemocnice

Fryštát, , Czechia

Klinikum Kulmbach

Kulmbach, Bavaria, Germany

Marienhaus Klinikum

Bendorf, , Germany

Neurochirurgische Universitatsklinik

Freiburg im Breisgau, , Germany

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Mediterraneo

Glyfada, , Greece

The Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Instituto Ortopedici Rizzoli

Bologna, , Italy

Fatebenefratelli Hospital

Milan, , Italy

Bergman Clinics

Naarden, , Netherlands

Franciscus Ziekenhuis Roosendaal

Roosendaal, , Netherlands

University Clinical Center

Gdansk, , Poland

Hospital San Joao

Porto, , Portugal

Ustredna Vojenska Nemocnica SNP

Ružomberok, , Slovakia

Hospital Clinic De Barcelona

Barcelona, , Spain

Guys & St; Thomas NHS Trust

London, , United Kingdom

Countries

Austria; Belgium; Canada; Czechia; Germany; Greece; Israel; Italy; Netherlands; Poland; Portugal; Slovakia; Spain; United Kingdom

Other Identifiers

MASTERS-D Study

Identifier Type: -

Identifier Source: org_study_id