Study on Orthosis in Cervical Spine Fracture Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University Hospital
About this trial
Background and Purpose:
Neck fractures affect over 1,100 people in Sweden each year, with the majority being frail older adults. Most neck fractures are stable and therefore treated without surgery, typically using a rigid collar. However, the collar only limits neck movement by 40-50% and can cause pressure sores, as well as difficulties with swallowing and breathing. Because of these issues, the latest Swedish national guidelines for pre-hospital and hospital spinal motion restriction have replaced the rigid collar with other methods. This raises the question of whether the rigid collar still has a role in the modern treatment of stable neck fractures.
The aim of this study is to determine whether treatment with or without a rigid collar leads to equally good healing outcomes.
Method:
All adults diagnosed with a stable neck fracture deemed suitable for non-surgical treatment will be included in the study at the time of registration in the Swedish Fracture Register (SFR). Participating hospitals will be randomly assigned (1:1) to either use no collar at all or a rigid collar for 12 weeks. After an initial period of 1.5 years, the hospitals will switch to the opposite treatment group. A total of 616 participants are expected to be included within 3 years.
At the one-year follow-up, investigators will evaluate how many participants in each treatment group that required a switch to surgical stabilization due to treatment failure. Secondary outcomes will include quality of life, neck pain, and the need for assistive devices in relation to disability and complications in both groups.
Summary:
Non-surgical treatment rarely fails, and the need to switch from non-surgical treatment to surgery is very uncommon. The rigid collar is often prescribed out of habit, without much consideration for its potential negative effects. If this study shows that the rigid collar is unnecessary for treating stable neck fractures, frail older adults-who often struggle with collar-related discomfort, malnutrition, and pressure sores-could avoid unnecessary suffering.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged > 18 years with a stable cervical spine fracture*.
A history of recent trauma (within 3 weeks).
Recruited within 3 weeks of injury.
Determined by the consultant spinal surgeon as suitable for non-surgical treatment.
Disqualifiers
New neurological deficit attributable to the fracture.
Additional cervical spine fracture not suitable for non-surgical treatment.
Underlying condition with risk of spinal instability (e.g., ankylosing spondylitis, DISH, rheumatoid arthritis).
Fracture suspected to be older than 3 weeks at the time of assessment.
Trial design
Design model
Parallel
Treatments tested in this trial
A rigid cervical collar
DeviceThe rigid cervical collar is used for spinal motion restriction for 12 weeks for the non-surgical treatment of a stable cervical spine fracture.
Treatment groups
616 Participants
are divided into 2 treatment groupsGroup A: Non-surgical treatment with a rigid collarExperimental treatment 1 intervention
Group B: Non-surgical treatment without a rigid collarNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants that had surgery within 1 year after the fracture incident
Treatment failure, defined as non- surgical treatment converted to surgical treatment, measured at 1 year of follow-up. All participants that receive cervical spine surgery within 1 year after the cervical spine fracture incident, are accounted for and compared between the groups.
Time frame
From enrollment to the 1 year of follow-upSecondary outcomes
1
European quality of life 5 dimensions 5 lite (EQ-5D 5L)
Change from baseline to one year of follow-up, in the EQ-5D 5L index with a higher number representing better life quality, ranging from -0.59 to 1.00 (10).
Time frame
From enrollment to 1 year of follow-up.2
European quality of life health scale (EQ-5D health)
Change from baseline to one year of follow-up, in EQ-5D health, ranging from 0-100 with higher scores indicating better health.
Time frame
From enrollment to 1 year of follow-up.3
Short musculoskeletal function assessment (SMFA)
Change from baseline to one year of follow-up, in the SMFA (11), a 46-item questionnaire describing the patient´s musculoskeletal function, containing both a dysfunction index and a bother index. The indexes range from 0-100.
Time frame
From enrollment to 1 year of follow-up.4
Adverse events
Adverse events might be pressure ulcer, difficulty in swallowing or breathing or other uncomfortable experiences. Prolonged neck pain and fracture pseudarthrosis is an adverse event as long as no surgical treatment has been performed to resolve the neck pain or fracture pseudarthrosis.
Time frame
From enrollment to 1 year of follow-up.Other outcomes
1
Neck disability index (NDI)
A subgroup analysis will be performed to investigate the disability in participants following a cervical spine fracture. One of the most common disease specific indices for neck pain and disability is the NDI (16). NDI ranges from 0-100 % with higher scores indicating severe disability. The MCID is 15%-17% (16, 17). NDI is not available in the Swedish fracture register, while the EQ-5D and SMFA is. A subgroup of 100 participants in Uppsala will be asked to fill in both NDI and the SMFA to investigate correlations between the two PROMs. Our previous experience is that the Oswestry disability index (ODI), the corresponding disability index constructed for back pain, have a high correlation to SMFA (18). It is likely that NDI has a similar correlation to SMFA as ODI.
Time frame
From enrollment to 1 year of follow-up.2
Compliance to rigid collar treatment
A single-center sub-group of 50 patients will be asked to participate in a study concerning compliance to rigid collar treatment. After verbal and written information and a signed consent has been obtained a small sensor will be placed inside the cervical collar. The sensor measures the warmth from the neck when the collar is worn and will register if the collar is taken off.
Time frame
From enrollment to 12 weeks of follow-up.3
Osteopororsis screening
A single-center sub-group of 50 participants with a stable cervical spine fracture assigned to non-surgical treatment, will be asked to participate in a study concerning osteoporosis screening. After verbal and written information and a signed consent has been obtained, a Dual energy X-ray Absorptiometry (DXA) will be performed. If the participant already has been screened with a DXA previously a new DXA will examine the change in bone mineral density (BMD) over time.
Time frame
From enrollment to 12 weeks of follow-up.Sponsors and contacts
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Source ClinicalTrials.gov