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Does size matter? Clinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study


- candidate number19208
- NTR NumberNTR4705
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2014
- Secondary IDsNL50062.058.14 
- Public TitleDoes size matter? Clinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study
- Scientific TitleClinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study
- ACRONYMCOnnECT.
- hypothesisDegenerative disease of the cervical spine is the most common indication for (cranio)cervical fixation, as it is the most common cause of myelopathy and radiculopathy, causing progressive functional disability and impairment. However, consensus has yet to be reached on the extent of the procedure. The extent is, in part, based on the clinical outcome and complications of the procedure. The aim of this study is to prospectively observe and assess the clinical outcome of posterior (cranio)cervical fixations in patients with degenerative cervical spine disease, differentiated for the extent of the procedure
- Healt Condition(s) or Problem(s) studiedCervical spine
- Inclusion criteria1. Male and female patients aged between 18 and 80 years;
2. Degenerative cervical spine disease requiring posterior (cranio)cervical fixation, with or without decompression;
3. Radiological findings in accordance with clinical signs and symptoms;
4. Patient is able and willing to comply with the follow-up schedule and protocol;
5. Patient is able to provide informed written consent
- Exclusion criteria1. Additional anterior fixation required;
2. Cervical spine surgery in the last 6 months;
3. Other cervical spine disease, e.g. trauma, tumor
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mei-2015
- planned closingdate30-apr-2022
- Target number of participants220
- InterventionsPosterior (cranio)cervical fixations stratified into the following five groups:
1. C0 to C2/3;
2. C0 to C4/5/6;
3. C0 to T2/3;
4. Cervical fixation > 2 levels;
5. Cervicothoracic fixation
- Primary outcomeClinical outcome: Neck Disability Index (NDI)
- Secondary outcomeNeurologic status: Japanese Orthopaedic Association (JOA) score;
Surgical outcome: Likert scale;
Pain: Visual Analogue Scale (VAS) for arm and neck pain;
Quality of life: 36-item Short Form health survey (SF-36), European Quality of life-5 Dimensions (EQ-5D);
Mental health: Hospital Anxiety and Depression Scale (HADS);
Radiologic data: cervical spine alignment, segmental range of motion (ROM) at the operative levels;
Complications, including revision surgery and mortality
- TimepointsFollow-up visits are scheduled to be 3, 6, 12 and 24 months. Patients will also be evaluated early postoperative, during hospitalization
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES C.N. Lie Tjauw
- CONTACT for SCIENTIFIC QUERIES C.N. Lie Tjauw
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Medtronic B.V.
- PublicationsN/A
- Brief summaryAll patients aged between 18 and 80 years with degenerative cervical spine disease requiring posterior (cranio)cervical fixation, with or without decompression, will be asked to participate in this study. Those who meet the inclusion criteria and have given written informed consent will be included in the study. The aim of this study is to prospectively observe and assess the clinical outcome of posterior (cranio)cervical fixations in patients with degenerative cervical spine disease, differentiated for the extent of the procedure.
- Main changes (audit trail)Timepoints:
Old: Follow-up visits are scheduled to be 3, 6, 12 and 24 months. Patients will also be evaluated early postoperative, during hospitalization.

New:Follow-up visits are scheduled to be 3 months, 6 months, 1-2- 5 years.
- RECORD30-jul-2014 - 11-apr-2015


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