PRESTIGE Observational Study - Full Text View

Sponsored by:	Medtronic Spine, Biologics & Navigation
Information provided by:	Medtronic Spine, Biologics & Navigation
ClinicalTrials.gov Identifier:	NCT00875810

Purpose

Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence. The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).

Condition
Degenerative Cervical Disc Disease

Study Type:	Observational
Study Design:	Prospective
Official Title:	PRESTIGE Observational Study

Further study details as provided by Medtronic Spine, Biologics & Navigation:

Primary Outcome Measures:

EQ-5D, NDI, VAS [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of pain prior to enrollment [ Time Frame: at Baseline visit ] [ Designated as safety issue: No ]
Drug regimen [ Time Frame: throughout the course of the study ] [ Designated as safety issue: No ]
Range of Motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Heterotopic Ossification [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Implantation measurements [ Time Frame: at surgery visit ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: ongoing throughout the course of the study ] [ Designated as safety issue: No ]
Economic considerations (e.g. days in hospital, return-to-work) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observation Patients fulfilling IFU of Prestige(r) LP Cervical Disc criteria, BMI <= 35, no diabetes, no cervical instability, no extensive decompression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with DDD who are scheduled to receive a cervical arthroplasty.

Criteria

Inclusion Criteria:

Patient must be willing to sign a Patient Data Release Form.
Patient with DDD who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.

Exclusion Criteria:

Patient fulfills any contraindication according to the product description.
Patient has not reached the age of legal consent according to local laws.
Patient has diabetes.
Patient has Body Mass Index (BMI) > 35.
Patient has affected disc not between C3/C4 and C6/C7.
Patient with instability of cervical spine.
Patients who will receive extensive decompression.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875810

Contacts

Contact: Clinical Research Manager

++800 633 87425

prestige.study@medtronic.com

Locations

Czech Republic
	Recruiting
Prague, Czech Republic
	Recruiting
Plzen, Czech Republic
Estonia
	Not yet recruiting
Tallinn, Estonia
Greece
	Not yet recruiting
Athens, Greece
	Not yet recruiting
Heraklion, Greece
Hungary
	Not yet recruiting
Budapest, Hungary
Poland
	Recruiting
Szczecin, Poland
	Recruiting
Konstancin, Poland
	Recruiting
Zakopane, Poland
	Recruiting
Zielona Gora, Poland
	Recruiting
Opole, Poland
	Recruiting
Piekary Slaskie, Poland
	Not yet recruiting
Olstyn, Poland
	Not yet recruiting
Chelm, Poland
Slovakia
	Recruiting
Nove Zamky, Slovakia

Sponsors and Collaborators

Medtronic Spine, Biologics & Navigation

Investigators

Study Chair:

Clinical Research Manager

Medtronic Spine & Biologics, Clinical Dept. CEEGI

More Information

No publications provided

Responsible Party:	Medtronic Spine and Biologics Division, Central & Eastern Europe, Greece and Israel ( Clinical Research Manager )
Study ID Numbers:	PRESTIGE Observational Study
Study First Received:	April 1, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875810 History of Changes
Health Authority:	Czech Republic: Ethics Committee; Slovenia: Ethics Committee; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Greece: Ethics Committee

ClinicalTrials.gov processed this record on September 11, 2009