PRESTIGE Observational Study

Degenerative Cervical Disc Disease Clinical Trial

Official title:

PRESTIGE Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875810
• Other study ID #: PRESTIGE Observational Study
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: January 26, 2016
• Start date: April 2008
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeHungary: Institutional Ethics CommitteeKuwait:Local Ethics CommitteePoland: Ethics CommitteeSaudi Arabia: Ethics CommitteeSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovak Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Description:

Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.

Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.

The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.

Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.

Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.

The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Cervical Disc Disease

Locations

Country	Name	City	State
Czech Republic	Hospital Plzen - Lochotin	Plzen
Czech Republic	Hospital Plzen - Lochotin	Plzen
Czech Republic	University Clinic Motol	Prague
Greece	Agia Olga Hospital	Athens
Hungary	National Center for Spinal Disorders	Budapest
Hungary	National Center for Spinal Disorders	Budapest
Kuwait	Al-Salam International Hospital	Kuwait
Kuwait	Al-Salam International Hospital	Kuwait City
Kuwait	Razi Hospital for Orthopedic Surgery	Kuwait City
Poland	Centrum Ksztalcenia I Rehabilitcji	Konstancin
Poland	Centrum Ksztalcenia I Rehabilitcji	Konstancin
Poland	Centrum Rehabilitacji im.prof. M.Weissa "STOCER"	Konstancin
Poland	Centrum Rehabilitacji im.prof.M.Weissa "STOCER"	Konstancin-Jeziorna
Poland	State Hospital- Wojewodzkie Centrum	Opole
Poland	Specialist Hospital Prof. Alfreda Sokolowskiego	Szczecin
Poland	Specialist Hospital Prof. Alfreda Sokolowskiego	Szczecin
Poland	Orthopaedic University Hospital in Zakopane	Zakopane
Poland	Orthopaedic University Hospital in Zakopane	Zakopane
Poland	State Hospital- Szpital Wojewodzki	Zielona Gora
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Jeddah
Serbia	Neurosurgical Clinic KCS	Belgrade
Serbia	Neurosurgical Clinic KCS	Belgrade
Serbia	Clinical Center Niš	Niš
Serbia	Clinical Center Nis Neurosurgical Clinic	Nis
Serbia	Clinical Center of Vojvodina	Novi Sad
Serbia	Clinical Center of Vojvodina Neurosurgical Clinic	Novi Sad
Slovakia	NsP Nové Zámky Hospital	Nové Zamky

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Czech Republic,  Greece,  Hungary,  Kuwait,  Poland,  Saudi Arabia,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Duration of Pain Prior to Enrollment	Documentation of duration of pain prior to enrollment	Baseline visit	No
Secondary	Intervertebral Disc Space		2 years	No