Long-term Follow-up Motion Analysis of ACD Versus ACDA

NCT04545983 | Completed DMC

• 1 other identifier: Z2020101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment. Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA. Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial. Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery. Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made. Main study parameters/endpoints: The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.

Conditions

Cervical Myelopathy; Cervical Radiculopathy; Spinal Stenosis; Spinal Disease; Spine Degeneration; Spine Fusion

Keywords

Anterior Cervical Discectomy; Anterior Cervical Discectomy with Arthroplasty; ACD; ACDA; Cervical Motion; Long-term Follow-up; Motion Analysis

Outcome Measures

Primary Outcomes (2)

• Motion Analysis

  The sequence of segmental contributions in sagittal rotation during flexion and extension in the lower cervical spine at the long-term after ACDA or ACD surgery for CDDD will be defined. There will be differentiated between normal or abnormal movement amongst ACD and ACDA.

  9,5 years average

• Level of Degeneration

  At the start of the cinematographic recording, one image will be saved as a lateral X-ray of the cervical spine to determine Kellgren's 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.

  9,5 years average

Secondary Outcomes (5)

• VAS Score

  9,5 years average

• NDI

  9,5 years average

• SF-36

  9,5 years average

• Odom's Outcome Criteria

  9,5 years average

• New complaints and/or surgeries

  9,5 years average

Study Arms (2)

ACD

ACTIVE COMPARATOR

In the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA.

Other: Motion Analysis

ACDA

EXPERIMENTAL

In the previously conducted RCT 27 adult patients with an indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI, were included and randomized to undergo ACD or ACDA.

Other: Motion Analysis

Interventions

Motion Analysis OTHER

Cinematographic recordings will be made. 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.

ACD; ACDA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An indication for ACD because of a monoradicular syndrome, corresponding to the C5-C6 or C6-C7 level, with corresponding pathology on MRI.
• Aged 18-55 years.
• Able to actively perform flexion/extension movement.
• Able to read the information form and sign IC.
• All participants of previous RCT
• Able to perform flexion/extension movement of the cervical spine
• Signed IC.
• Patients were excluded in the previous 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Limburg, 6419 PC, Netherlands

Location

MeSH Terms

Conditions

Radiculopathy; Spinal Stenosis; Spinal Diseases

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Henk Van Santbrink, Md, PhD, Professor

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a fundamental research project in which a cohort of previously operated patients will be included. All of these patients were previously operated in the setting of an RCT an underwent ACD or ACDA for CDDD. In the RCT flexion and extension cinematographic recordings of the cervical spine were made before surgery, and at three months and one-year post-operatively. This study investigates the long-term follow-up of this same study population. The average follow-up duration is 9 years (range 6-13 years). We make similar flexion and extension cinematographic recordings to assess the sequence of segmental contributions of the lower cervical spine years after ACD and ACDA surgery for CDDD. The sROM and level of degeneration will be assessed as a secondary outcome. Moreover, the long-term clinical outcomes will be assessed through questionnaires.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: September 11, 2020
• Study Start: February 12, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 25, 2022
• Last Updated: January 27, 2023

Record last verified: 2021-05

Locations

NL (1)