Cervical spine movement, before and after anterior cervical discectomy (ACD). ACD, pure intervertebral discectomy (1) compared to intervertebral discectomy followed by implantation of an intervertebral disc prosthesis (2) in patients with a radicular syndrome. A randomised study

Cervical spine movement, before and after anterior cervical discectomy (ACD). ACD, pure intervertebral discectomy (1) compared to intervertebral discectomy followed by implantation of an intervertebral disc prosthesis (2) in patients with a radicular syndrome. A randomised study - Cervical spine movement, before and after anterior cervical discectomy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38336

Enrollment

Registered

2007-05-02

Start date

2007-12-10

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

cervical disc prolaps cervical radiculopathy

Interventions

Anterior cervical discectomy (standard treatment option) in the control group, additional impantation after discectomy of a disc prosthesis in the investigational group.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Studygroups: Clinical moniradicular syndrome C6 or C7 age between 18 and 55 Monosegmental abnormality on MRI Able to perform flexion and extension movement by the patient self Segmental Range of Motion (ROM) > 2 degrees Willingness to Follow up Informed consent;Control-group: Age 18-55 Subject is able to actively perform flexion and extension movement Informed consent Anamnestic and based on the neck disability index no neck complaints (NDI

Exclusion criteria

Exclusion criteria: -Cervical spinal surgery in history -Degenerative spinal deformities on multiple levels -Positive sign of L'Hermitte -Active infection -Immature bone -Cervical spine tumor -Radiotherapy in history -Pregnancy -Cervical myelopathy -Not able to speak and understand the Dutch language;Control-group: -Cervical spinal surgery in history -X-ray imaging of head/cervical spine/thorax in the previous year -Degenerative spinal deformities (vertebral bodies or zygapophysial joints) -Positive sign of L'Hermitte -Active infection -Immature bone -Cervical spine tumor -Radiotherapy in history -Pregnancy -Cervical myelopathy -Not able to speak and understand the Dutch language

Design outcomes

Primary

Measure	Time frame
Movement testing of the cervical vertebral column in both groups according the given methods. Comparing both investigational arms, defined to normal values.	—

Secondary

Measure	Time frame
Clinical condition of the different patients groups according the used outcome/scoring scales	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)