Cervical Radiculopathy
Conditions
Keywords
Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol
Brief summary
FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion (ACDF) procedure.
Detailed description
To determine whether early discharge (outpatient care) is noninferior to inpatient care, the investigators will randomize 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that early discharge is not significantly worse (inferior) than the current care in terms of change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, within statistical variability, by a margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to health care system. Secondary outcomes in the study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS), sickness absence days, return to previous leisure activities, and complications. Patients who are eligible for the trial, but are not willing to undergo randomization, will be asked to be included in a simultaneous, pragmatic follow-up cohort.
Interventions
PROCEDUREDischarge on the day of surgery
Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
Sponsors
Turku University Hospital
Oulu University Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
1. Cervical radiculopathy syndrome (CRS) unresponsive to non-operative treatment for at least six weeks or with severe progressive signs and symptoms of nerve root compression during conservative treatment of shorter duration. 2. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8. 3. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms 4. Neck Disability Index score ≥30 out of 100 5. Age between 18 to 62 years 6. No previous cervical operations 7. Currently employed 8. No co-morbidities causing a need for a sick leave 9. Provision of informed consent from the participant 10. No contraindication for randomization in postoperative check (see below)
Exclusion criteria
1. MRI finding inconsistent with patient's symptoms 2. Diagnosed osteoporosis or permanent use of oral corticosteroids 3. ACDF operation requiring plate or cage fixation with screws 4. Active malignancy 5. American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients) 6. Pregnancy 7. Abundant use of alcohol, drugs or narcotics 8. No possibility to be accompanied by an adult person over the first postoperative night after the surgery 9. Insufficient Finnish language skills 10. Distance to the closest hospital emergency more than 60 min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Neck Disability Index at 6 months after operation | Before and up to 6 months after operation | Neck disability Index scale score ranges from 0 to 100%. Score 0 indicates no disability as score 100% indicates worst possible disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Numeric rating scale on neck pain at six months after operation | Before and up to 6 months after operation | Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain |
| Change from baseline Numeric rating scale on arm pain at six months after operation | Before and up to 6 months after operation | Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain |
| Rate of returning to previous leisure activities after operation | Before and up to 6 months after operation | Before the operation, participants will be asked to name the most important daily leisure activity they are not able to perform because of the disease. At each follow-up time point (Table 2), participants will be asked to respond to the following question: Have you been able to return to your leisure activity? (yes or no) |
| Change from baseline Work Ability Score (WAS) at six months after operation | Before and up to 6 months after operation | Numeric rating score ranges from 0 to 10, where 0 indicates that participant is completely incapable to work and 10 indicates participants work ability at its best |
| The duration of sick leave | Before and after operation | the number of sickness absence days from work both before and after the operation. The number of sickness absence days will be treated as a continuous variable |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative success | at one week, one month, three months and six months after operation | patient subjectively rates the perception of operative success from poor to excellent by the modified Odom's criteria. the first and second categories ('excellent' and 'good') as a successful outcome of the operation and conversely, last two categories ('fair' and 'poor') as an unsuccessful outcome. |
| Rate of complications and adverse effects | From operation up to six months postoperatively | The rate of complications related to intervention or operation in both group after operation |
| Patient satisfaction to treatment | at six months after operation | patients' global assessment of satisfaction to the treatment at six months after operation with this question: If you were to choose again, would you choose an operative treatment? (yes or no). |
| Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation | Before and at 6 months after operation | EQ-5D-5L descriptive score ranges from 0 (no problems in health state) to 25 (maximal problem in health state). EQ-5D-5L Visual analogic score (VAS) ranges form 0 (the worst health) to 100 (the best health) assessed by participant. |
Countries
Finland
Outcome results
None listed