Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

NCT00749996 | Completed Phase 4 Results

• 1 other identifier: DIAM™ Study
• Study Type: interventional
• Target: 165
• Locations: 8 countries
• Sites: 19

Brief Summary

The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.

Conditions

Sciatica; Back Pain

Outcome Measures

Primary Outcomes (1)

• To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).

  The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.

  6 Months

Secondary Outcomes (1)

• To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).

  12 Months

Study Arms (2)

Investigational group

EXPERIMENTAL

Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System

Device: DIAM™ Spinal Stabilization System

Control group

ACTIVE COMPARATOR

Single level herniectomy

Procedure: Herniectomy

Interventions

DIAM™ Spinal Stabilization System DEVICE

The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.

Investigational group

Herniectomy PROCEDURE

Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification);
• Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year);
• Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale);
• Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette \& Fardon, 2001) as confirmed by MRI at the target level;
• Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001);
• Has an Oswestry Disability Index (ODI) score ≥ 34%;
• Has been treated non-operatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, hydrotherapy, acupressure/acupuncture, massage, bracing and/or spinal injections) for at least 6 continuous weeks unless strong clinical grounds for expediting surgery;
• Patient male or female, age 20-60 years inclusive and is skeletally mature;
• Is willing and able to comply with the study plan and able to provide an informed consent;

You may not qualify if:

• Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level;
• Has a symptomatic disc herniation at more than one lumbar level;
• Requires a herniectomy at more than one lumbar level;
• Has a disc degeneration at the treated and adjacent levels \> Grade IV (Pfirrmann, 2001);
• Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level;
• Has Modic changes on MRI greater than Grade I at the target level;
• Has Modic changes on MRI at the adjacent levels;
• Has an advanced degree of retrolisthesis as shown by lateral X-rays (\> 25%, i.e. grade I as per Meyerding);
• Has a clinical evidence of lysis, antero listhesis or scoliosis (Cobb angle more than 10°);
• Has signs of segmental instability: more than 4 mm of translation or more than 10° angular motion between adjacent end plates (comparing flexion and extension views);
• Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta);
• Has had any previous lumbar spine surgery;
• Has a Waddell signs of inorganic behaviour score greater than or equal to 3;
• Has evidence of an active disruptive psychiatric disorder, cognitive impairment or other known condition, significant enough to impact the perception of pain, precludes surgical procedure, clinical evaluation and/or ability to evaluate treatment outcome as determined by investigator;
• Has a known allergy to silicone, polyethylene, or titanium;

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (19)

Cliniques Universitaires Bruxelles Hôpital Erasme

Brussels, Belgium

Location

AZ Sint-Lucas

Ghent, Belgium

Location

Hôpital de la Citadelle

Liège, Belgium

Location

AZ Sint-Elisabeth Hospital

Zottegem, Belgium

Location

University Hospital Olomouc, dept of Neurosurgery

Olomouc, Czechia

Location

Otto-Von-Guericke Universität

Magdeburg, Germany

Location

CA NCH Klinikum rechts der Isar/München

München, Germany

Location

Medizinisches Zentrum Kreis Aachen

Würselen, Germany

Location

Anthea Casa di Cura

Bari, Italy

Location

Istituto Ortopedico Galeazzi

Milan, Italy

Location

St. Luke Hospital, University of Rzeszow, dept of Neurosurgery

Tarnów, Poland

Location

Hospital Universitari Bellvitge

Barcelona, Spain

Location

Hospital de León

León, Spain

Location

Hôpital Fribourgeois

Fribourg, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Location

Chase Farm Hospital

Enfield, United Kingdom

Location

St. Georges Hospital

London, United Kingdom

Location

Greater Manchester Neuroscience Center

Salford, United Kingdom

Location

MeSH Terms

Conditions

Sciatica; Back Pain

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The current study was limited by not reaching the target enrollment. Because of the low patient recruitment rate, despite major efforts by the investigators and sponsor, enrollment was stopped prematurely.

Results Point of Contact

• Title: Irène Ayer, Clinical research specialist
• Organization: Medtronic Spinal & Biologics

irene.ayer@medtronic.com

+41 21 803 84 27

Study Officials

• Ferdiand Krappel, Dr.

  Spitalzentrum Oberwallis, Brig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: November 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 28, 2016
• Results First Posted: May 23, 2014

Record last verified: 2016-01

Locations

DE (3); GB (3); CZ (1); IT (2); BE (4); PL (1); ES (2); CH (3)