NCT00875810

PRESTIGE Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Cervical Disc Disease

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-04-03
• Last updated: 2016-01-28
• Results posted: 2015-03-17

Locations

26 sites across 8 countries: Czechia, Greece, Hungary, Kuwait, Poland, Saudi Arabia, Serbia, Slovakia