Stability and function of the Prodisc-C VIVO cervical disc replacement. A radiostereometric (RSA) study

Stability and function of the Prodisc-C VIVO cervical disc replacement. A radiostereometric (RSA) study - Prodisc-C Vivo RSA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38907

Enrollment

Registered

2013-11-13

Start date

2014-06-05

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical disc disease

Interventions

All patients receive the Prodisc-C Vivo cevical disc replacement.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Single level C3-7 radiculopathy due to herniated disc, degenerative disc disease or spondylosis (confirmed by MRI) * Preserved motion at symptomatic level (confirmed by flexion/extension X-rays) * Failure of conservative treatment for at least 6 weeks * Age > 21 years * Written informed consent

Exclusion criteria

Exclusion criteria: * Cervical deformity (kyphosis or lordosis or congenital) * Loss of lordosis * Multilevel spondylosis * Disc height less than 50% * Cervical trauma and instability * Facet arthritis * Infections * Previous surgery at index level * Osteoporosis * Pregnancy (or plans to become pregnant during the study) * BMI > 30 * Metastases

Design outcomes

Primary

Measure	Time frame
Primary outcome: Stability of both the upper and lower end plates of the Prodisc-C Vivo cervical disc replacement with regard to the adjacent cervical vertebrae. Stability is defined as the absence of micro-motion or migration. Migration is defined as the amount of translation in mm along the x-, y-, and z-axis and rotation in degrees around the x-, y-, and z-axis. As the accuracy is only acceptable for the translational component of migration, this is will be the main focus in this study. Migration will be measured using model-based radiostereometric analysis (MB-RSA). At 6 weeks, double RSA-measurements will be performed to assess the precision of the measurement method and to assess the level of migration that is no migration.	—

Measure

Time frame

Primary outcome: Stability of both the upper and lower end plates of the Prodisc-C Vivo cervical disc replacement with regard to the adjacent cervical vertebrae. Stability is defined as the absence of micro-motion or migration. Migration is defined as the amount of translation in mm along the x-, y-, and z-axis and rotation in degrees around the x-, y-, and z-axis. As the accuracy is only acceptable for the translational component of migration, this is will be the main focus in this study. Migration will be measured using model-based radiostereometric analysis (MB-RSA). At 6 weeks, double RSA-measurements will be performed to assess the precision of the measurement method and to assess the level of *migration* that is no migration.

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Secondary

Measure	Time frame
Secondary outcomes * Neck Disability Index (NDI) * NRS pain (arm and neck) * Maximal flexion and maximal extension mobility of the cervical spine using radiographic motion in the sagittal plane was measured according to the method described by Frobin et al.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)