PRESTIGE Observational Study

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Medtronic

Status

Completed

Conditions

Degenerative Cervical Disc Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT00875810
PRESTIGE Observational Study

Details and patient eligibility

About

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).

Full 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.

Enrollment

194 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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