To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the difference in pain after six weeks noted on the
NRS-score.
Secondary outcome
1. Pain
a. as reported on the NRS scale on each day the brace is worn directly
post-operative (average of 24 hours) and on 2, 6, 12 weeks and 6, 12 months
(average of last week).
b. Pain medication use at the same measuring moments. Rated on three steps;
paracetamol, NSAID*s and opiods, noted as yes/no.
2. Quality of life
a. EQ-5D-5L on day of discharge and at 12 weeks and 6, 12 months
3. Back pain related function
a. ODI at 2, 6, 12 weeks and 6, 12 months.
4. Kyphosis (Cobb-angle)
a. Measured on sagittal CT pre-operative and conventional standing lateral
X-ray at discharge and 6, 12 weeks and 6, 12 months.
5. Increased risk of infections:
a. Wound infection (culture proven or antibiotics given)
b. Decubitus (clinically diagnosed and noted)
c. Pulmonary infections (culture proven or antibiotics given)
d. Urinary tract infections (urinary sample, culture proven or antibiotics
given)
6. Ileus (clinically diagnosed, gastic drainage tube given and noted in chart)
7. Clinically relevant deep venous thrombosis (ultrasound proven and treated)
8. Hospital stay (days)
9. Return to work (weeks/days)
10. Consolidation on long term as seen on X-rays
11. Subjective feeling of:
a. Feeling the need of an orthosis if in the same situation again?
b. Satisfaction with orthosis
c. Subjective feeling of additional value of the orthosis
12. Orthosis compliance
Background summary
There is no evidence in the current literature regarding the additional value
of an orthosis after surgically treated thoracolumbar spine fractures.
Study objective
To assess whether an orthosis provides additional pain relief compared to no
orthosis after posteriorly fixated thoracolumbar spine fractures. Primary
outcome is difference in pain at six weeks post-operatively. Secondary
objectives are painmedication used, pain at other moments, pain related
disability, quality of life, long-term kyphosis, possible complications,
hospital stay, return to work and subjective feeling on benefit or disadvantage
from the orthosis.
Study design
Randomized controlled intervention study, non-inferiority trial.
Intervention
Orthosis versus no orthosis.
Study burden and risks
Currently, all patientes receive an orthosis after surgically dorsal
stabilization of thoracolumbar fractures, except cases when the treating
surgeon has good reasons not to prescribe an orthosis. With subjects being
randomized between the use of an orthosis or no orthosis there is no additional
risk, there is only one half which does not have to wear an orthosis. We
hypothesize there is no difference in postoperative pain and there might be a
lower risk of complications related to the orthosis. Participants will receive
the same care as patients not included. During hospitalization each day a pain
score questionnaire is conducted and on the day of discharge there are two
additional questionnaires. Compared to patients not included in the study,
included patients will have no additional outpatient appointments but will
receive two to three additional questionnaires during the standard outpatient
appointments. If the patient is unable to come to the outpatient clinic, an
email will be sent to fill in the questionnaires digitally and if there is no
response patients will be reminded through telephone or as a last resort the
questionnaire will be conducted through telephone. Standard follow-up X-rays
are used to measure kyphosis. While at home patients randomized to an orthosis
are asked to keep a short diary on their orthosis compliance.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Age 18 * 65 years
- Traumatic thoracolumbar spine fracture from thoracic 7 * lumbar 4
- AO fracture types A-C
- Undergoing surgical dorsal fixation for fracture
Exclusion criteria
- Inadequate knowledge of Dutch language or to fill in questionnaire
- Complete or partial spinal cord injury (ASIA A to D)
- (Additional) anterior surgical stabilization
- Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious
- Not able to walk before fracturing vertebra
- Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)
- Injury Severity Score (ISS) * 16
- Brain injury with Abbreviated Injury Score (AIS) * 4
- Solitary Lumbar 5 fracture
- Diagnosed osteoporosis; using bisphosphonates or diagnosed by DEXA-scan
- Psychiatric history
- Inability to wear an orthosis, most probable reasons:
o BMI > 35
o Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.
o Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.
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 |
|---|---|
| ClinicalTrials.gov | NCT03097081 |
| CCMO | NL58856.029.16 |