Clinical trial NCT00875810: PRESTIGE Observational Study
Official title: PRESTIGE Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Cervical Disc Disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: EQ-5D
timeFrame: 2 years
measure: Neck Disability Index (NDI) Score
timeFrame: 2 years
Secondary outcomes:
measure: Duration of Pain Prior to Enrollment
timeFrame: Baseline visit
measure: Intervertebral Disc Space
timeFrame: 2 years
Other outcomes:
Locations:
city: Plzen
country: Czech Republic
facility: Hospital Plzen - Lochotin
city: Plzen
country: Czech Republic
facility: Hospital Plzen - Lochotin
city: Prague
country: Czech Republic
facility: University Clinic Motol
city: Athens
country: Greece
facility: Agia Olga Hospital
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders
city: Kuwait City
country: Kuwait
facility: Al-Salam International Hospital
city: Kuwait City
country: Kuwait
facility: Razi Hospital for Orthopedic Surgery
city: Kuwait
country: Kuwait
facility: Al-Salam International Hospital
city: Konstancin-Jeziorna
country: Poland
facility: Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
city: Konstancin
country: Poland
facility: Centrum Ksztalcenia I Rehabilitcji
city: Konstancin
country: Poland
facility: Centrum Ksztalcenia I Rehabilitcji
city: Konstancin
country: Poland
facility: Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
city: Opole
country: Poland
facility: State Hospital- Wojewodzkie Centrum
city: Szczecin
country: Poland
facility: Specialist Hospital Prof. Alfreda Sokolowskiego
city: Szczecin
country: Poland
facility: Specialist Hospital Prof. Alfreda Sokolowskiego
city: Zakopane
country: Poland
facility: Orthopaedic University Hospital in Zakopane
city: Zakopane
country: Poland
facility: Orthopaedic University Hospital in Zakopane
city: Zielona Gora
country: Poland
facility: State Hospital- Szpital Wojewodzki
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Belgrade
country: Serbia
facility: Neurosurgical Clinic KCS
city: Belgrade
country: Serbia
facility: Neurosurgical Clinic KCS
city: Nis
country: Serbia
facility: Clinical Center Nis Neurosurgical Clinic
city: Niš
country: Serbia
facility: Clinical Center Niš
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina Neurosurgical Clinic
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Nové Zamky
country: Slovakia
facility: NsP Nové Zámky Hospital
Study officials:
affiliation: University Clinic Motol
name: Jan Štulik, MUDr
role: PRINCIPAL_INVESTIGATOR
References: