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

NCT01143324 | Completed Results

• 1 other identifier: MASTERS-D Study
• Study Type: observational
• Target: 255
• Locations: 14 countries
• Sites: 19

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.

Conditions

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

Keywords

Single or double level instrumented fusion; Degenerative lumbar spine; PLIF; TLIF; MAST procedure

Outcome Measures

Primary Outcomes (2)

• Time From Surgery to First Ambulation.

  The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital.

  From date of Surgery to date of First ambulation, assessed up to hospital discharge.

• Time to Surgery Recovery Day.

  The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors.

  From date of surgery until date of surgery recovery day assessed up to hospital discharge.

Secondary Outcomes (11)

• Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.

  Baseline, 12 months

• Leg Pain Intensity VAS Score as Compared to Baseline

  Baseline, 12 months

• EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.

  Baseline, 12 months

• Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.

  12 months

• Number of Patients Who Utilized Rehabilitation Programs

  From 6-12 months after the day of surgery

Study Arms (1)

MAST™ procedure

Device: MAST™ procedure

Interventions

MAST™ procedure DEVICE

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

MAST™ procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population comprises individuals that have an indication for a single or double level instrumented lumbar fusion for the treatment of the degenerative lumbar spine causing back and/or leg pain. Patients enrolled in this study will receive a single or double level instrumented fusion using PLIF or TLIF techniques via a MAST™ procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (19)

Klinikum Amstetten

Amstetten, Austria

Location

OLV Ziekenhuis

Aalst, Belgium

Location

Spine, Sports Medicine and Orthopedic Surgery

Saint John, New Brunswick, Canada

Location

Karvinska Hornicka Nemocnice

Fryštát, Czechia

Location

Klinikum Kulmbach

Kulmbach, Bavaria, Germany

Location

Marienhaus Klinikum

Bendorf, Germany

Location

Neurochirurgische Universitatsklinik

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Mediterraneo

Glyfada, Greece

Location

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Instituto Ortopedici Rizzoli

Bologna, Italy

Location

Fatebenefratelli Hospital

Milan, Italy

Location

Bergman Clinics

Naarden, Netherlands

Location

Franciscus Ziekenhuis Roosendaal

Roosendaal, Netherlands

Location

University Clinical Center

Gdansk, Poland

Location

Hospital San Joao

Porto, Portugal

Location

Ustredna Vojenska Nemocnica SNP

Ružomberok, Slovakia

Location

Hospital Clinic De Barcelona

Barcelona, 08036, Spain

Location

Guys & St; Thomas NHS Trust

London, United Kingdom

Location

Limitations and Caveats

Limitations of this study include the lack of a direct comparison of outcomes of minimally invasive surgery and open surgery, since it was designed as an observational trial and not designed as a randomized controlled trial.

Results Point of Contact

• Title: Christel Van Dam
• Organization: MedtronicSpineECA

christel.van.dam@medtronic.com

+31433566523

Study Officials

• Jörg Franke, PD Dr.

  Klinik für Wirbelsäulenchirurgie; Dortmund

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 8, 2019
• Results First Posted: August 19, 2014

Record last verified: 2016-01

Locations

CA (1); ES (1); CZ (1); IL (1); BE (1); GR (1); AU (1); DE (4); NL (2); PL (1); SL (1); GB (1); IT (2); PT (1)