The objective of this study is to compare short- and long-term surgical and clinical outcomes of patients with chronic neck pain and neck disability due to a single-level spinal disorder that undergo Anterior Cervical Discectomy followed by…
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the rate of fusion in the two treatment groups.
Secondary outcome
Further objectives of the study are to assess clinical outcome parameters in
both groups. Such parameters are primarily assessed using questionnaires (Neck
Disability Index, Myelopathy Disability Index, Visual Analogue Scales for pain
in the arm and neck and Prolo*s economic and functional scale.) The incidence
and severity of adverse events are also compared between groups.
Background summary
Anterior cervical disc excision followed by interbody arthrodesis is a standard
surgical procedure to treat patients with symptomatic cervical spondylosis.
Resorbable materials have recently been introduced in spinal surgery. The
advantage of these materials is that they offer the correct mechanical
environment to achieve fusion, but are absorbed over time, therefore avoiding
long term adverse events. The extent of this improvement needs to be assessed
objectively and compared to current standard care.
Study objective
The objective of this study is to compare short- and long-term surgical and
clinical outcomes of patients with chronic neck pain and neck disability due to
a single-level spinal disorder that undergo Anterior Cervical Discectomy
followed by interbody Fusion (ACDF) with either a bioresorbable (SOLIS RS) or
non-resorbable (SOLIS) interbody fusion device.
The primary (outcome measure) study objective is to determine the fusion
parameters of both patient groups. Secondary outcome measures include clinical
outcome parameters and safety and adverse events Parameters are primarily
assessed using questionnaires: Neck Disability Index, Myelopathy Disability
Index, Visual Analogue Scales for pain in the arm and neck and Prolo*s economic
and functional scale. The incidence and severity of adverse events is also
compared between groups.
Study design
Multi-site European prospective randomized controlled single blinded outcome
study
Intervention
Intercorporal cervical fusion via an anterior approach (ACDF). In one group a
bioresorbable (SOLIS RS) implant is used. The second group receives a
non-resorbable PEEK (SOLIS) implant. The patient is allocated to one of the two
groups via randomization.
Study burden and risks
The anterior single level cervical discectomy and fusion procedure is a well
described surgical technique, and is the routine surgical treatment for the
patients in the selected patient group.
The benefits of this procedure are pain relief and the improvement of
neurological symptoms. Every operation has certain risks regardless of the
study and irrespective of which implant is used. Participation in this study
does not increase the risks.
The burden for the patients involves that at the visits before the surgery and
at each follow up they will be asked to complete questionnaires regarding pain
and health issues.
Cite-Centre, Grand-rue 92
PO Box 1568, 1820 Montreux
CH
Cite-Centre, Grand-rue 92
PO Box 1568, 1820 Montreux
CH
Listed location countries
Age
Inclusion criteria
Willing and able to participate;
Patient is male or female and between 18 and 70 years of age;
Patient has clinical symptomatic myelopathy and/or radiculopathy;
Based on clinical history, physical examination and radiographic evidence, pain interpreted as emanating between C3/4 and C6/7;
No improvement of symptoms after at least 3 months of conservative treatment;
Progressive neurological deficit despite conservative management irrespective of the duration;
Evidence of degenerative changes between levels C3/4 and C6/7 (*spondylosis*) as shown on plain radiographs and/or CT scan and/or MRI. The pathology should be predominant on one level. Other levels may show degeneration, however, it should not be clinically necessary to operate on;
Use of autograft from the iliac crest or the spine is necessary;
Capable of providing informed consent.
Exclusion criteria
Previous cervical spine surgery at the symptomatic level to be operated on and previous cervical spine surgery during the last two years at other levels;
Symptomatic degenerative disc disorder at more than one cervical level;
Pregnancy or planning a pregnancy during the two year study;
Ongoing severe psychiatric illness or mental retardation;
Evidence of alcohol and/or drug abuse;
Inability to complete the questionnaires;
Local or general infection which could jeopardize the surgical objective;
Extensive local inflammatory reactions;
Proven or suspected hypersensitivity to materials;
Immunosuppressive pathologies;
Abnormal, immature or weak bone structure, insufficient quantity or quality or diseased bone that is incapable of supporting or stabilizing the device;
Severe pathologies of the airway, esophagus, abnormal vascostructure or bypassing nerves;
Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, previous cervical spinal fracture, inflammatory process or neoplasm (confirmed by radiographs and/or DEXA scans and/or CT and/or MRI);
Excessive physical activity.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16767.029.07 |