Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

194

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach

8 countries

26 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

Study Start

First participant enrolled

April 1, 2008

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed

Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

5.6 years

First QC Date

April 1, 2009

Results QC Date

December 19, 2014

Last Update Submit

January 26, 2016

Conditions

Degenerative Cervical Disc Disease

Outcome Measures

Primary Outcomes (2)

EQ-5D
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.
2 years
Neck Disability Index (NDI) Score
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.
2 years

Secondary Outcomes (2)

Duration of Pain Prior to Enrollment
Baseline visit
Intervertebral Disc Space
2 years

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Medtronic Spinal and Biologicslead

Study Sites (26)

Hospital Plzen - Lochotin

Pilsen, 32318, Czechia

Location

Hospital Plzen - Lochotin

Pilsen, Czechia

Location

University Clinic Motol

Prague, Czechia

Location

Agia Olga Hospital

Athens, Greece

Location

National Center for Spinal Disorders

Budapest, 1126, Hungary

Location

National Center for Spinal Disorders

Budapest, Hungary

Location

Al-Salam International Hospital

Kuwait City, Kuwait

Location

Razi Hospital for Orthopedic Surgery

Kuwait City, Kuwait

Location

Centrum Rehabilitacji im.prof.M.Weissa "STOCER"

Konstancin-Jeziorna, 05-510, Poland

Location

Centrum Ksztalcenia I Rehabilitcji

Konstancin, 05-510, Poland

Location

Centrum Ksztalcenia I Rehabilitcji

Konstancin, Poland

Location

Centrum Rehabilitacji im.prof. M.Weissa "STOCER"

Konstancin, Poland

Location

State Hospital- Wojewodzkie Centrum

Opole, 45-418, Poland

Location

Specialist Hospital Prof. Alfreda Sokolowskiego

Szczecin, 70-891, Poland

Location

Specialist Hospital Prof. Alfreda Sokolowskiego

Szczecin, Poland

Location

Orthopaedic University Hospital in Zakopane

Zakopane, 34-500, Poland

Location

Orthopaedic University Hospital in Zakopane

Zakopane, Poland

Location

State Hospital- Szpital Wojewodzki

Zielona Góra, 65-046, Poland

Location

King Faisal Specialist Hospital & Research Center

Jeddah, Saudi Arabia

Location

Neurosurgical Clinic KCS

Belgrade, 11000, Serbia

Location

Neurosurgical Clinic KCS

Belgrade, Serbia

Location

Clinical Center Nis Neurosurgical Clinic

Niš, 18000, Serbia

Location

Clinical Center Niš

Niš, Serbia

Location

Clinical Center of Vojvodina Neurosurgical Clinic

Novi Sad, 21000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, Serbia

Location

NsP Nové Zámky Hospital

Nové Zamky, Slovakia

Location

Limitations and Caveats

Low patient compliance at the 6 and 12 months follow up visits

Results Point of Contact

Title: Cristina Faria
Organization: MedtronicSpineECA

Study Officials

Jan Štulik, MUDr
University Clinic Motol
PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 3, 2009

Study Start

April 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 28, 2016

Results First Posted

March 17, 2015

Record last verified: 2016-01

Locations

SE(6)SL(1)CZ(3)KU(2)HU(2)GR(1)SA(1)PL(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations