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Long-term follow-up of movement of the cervical spine after anterior cervical discectomy (ACD) or anterior cervical discectomy with arthroplasty (ACDA)

Long-term follow-up of movement of the cervical spine after anterior cervical discectomy (ACD) or anterior cervical discectomy with arthroplasty (ACDA) - Cervical spine motion. Long term-follow up of ACDA and ACD.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49700
Enrollment
27
Registered
2020-09-28
Start date
2022-02-24
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Wervelkolom aandoeningen Cervical spine motion

Interventions

None listed

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients will now be included according to the following criteria: - All participants of previous RCT - Able to perform flexion/extension movement of the cervical spine - Signed informed consent

Exclusion criteria

Exclusion criteria: Patients were excluded in the RCT based on the following criteria, and will now be excluded based on the same criteria: - Ongoing or active infection - Previous or actual tumorous processes in the cervical region - Pregnancy - Previous radiation therapy in the cervical region - Not being able to speak Dutch

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to investigate whether the sequence of segmental contributions in the cervical spine in the long-term follow-up of ACD and ACDF had changed compared to the short-term follow-up and if this correlates to clinical symptoms. At the start of the cinematographic recording, one image will be saved as a lateral X-ray of the cervical spine to determine Kellgrens* Score (KS). The KS will be determined by two neurosurgeons and is a scoring method to determine severity of degenerative disc disease, using five gradations: * Grade 0: absence of degeneration in the disc. * Grade 1: minimal anterior osteophytosis. * Grade 2: definite anterior osteophytosis, possible narrowing of the disc space, some sclerosis of the vertebral plates. * Grade 3: moderate narrowing of the disc space, sclerosis of the vertebral plates, osteophytosis. * Grade 4: severe narrowing of the disc space, severe sclerosis of the vertebral plates, multiple large osteophytes. Cinematographic recordings: participants are seated on a crutch, adjustable in height, with their neck, shoulders and head free. Before recordings are made, participants will be instructed to perform the prescribed flexion and extension movement in about 10 seconds with 7 frames per second. . Participants are placed on the crutch with their shoulder*s perpendicular to the image intensifier to obtain sagittal images from the occiput till C7. As soon as the recording is started, the participant is instructed to move his head in the sagittal plane from maximal extension to maximal flexion, without moving the upper part of the body. It is important that the participants shoulders are kept as low as possible while making the recordings to ensure that all the cervical vertebrae are visible. The movement of the cervical spine should be as fluent as possible to prevent for sudden large rotations and translations between consecutive frames. The cinematographic recordings will be mad

Secondary

MeasureTime frame
The secondary outcome will be to determine the radiological sROM on the cinematographic recordings. The amount of degeneration will be assessed on the lateral X-ray according to the Kellgren's Score (KS). Clinical outcomes will be assessed according to the visual analogue score (VAS) score for neck and arm pain, the neck disability index (NDI), SF-36 and Odom Outcome Score. Patients will be asked to indicate whether they have been diagnosed with new episodes of CDDD and how these were treated. All patients will receive a clinical neurological exam to objectify clinical outcomes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)