"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Orthosis in Cervical Spine Fracture Treatment

NCT06848660

Cervical Spine Fractures Cervical Spine Injury Rigid Collar

NOT_YET_RECRUITING NA

Survival After Surgical Treatment of Axis Fractures in Elderly

NCT02839057

Spinal Fractures

COMPLETED

SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70

NCT06961578

Odontoid Fracture Elderly

NOT_YET_RECRUITING NA

Surgical Innovations in Treatment of Clavicle Fractures

NCT02247778

Complication

UNKNOWN NA

Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

NCT01078480

Displaced Midshaft Fracture of the Collar Bone

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will include 150 patients with a stable cervical fractures of vertebra C3-C7 with a Subaxial Cervical Spine Injury Severity (SLIC) Score 1-3 and randomize them in to two similar groups. One group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. There will be a clinical check up and a CT scan at 1, 6, 12 and 26 weeks after the initial injury. The investigators will compare the results between the two groups when it comes to fracture healing (CT based), level of function, pain and the length of sick leave with a total of 6 months of follow up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Collar Treatment of Stable Subaxial Spine Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

6 weeks

This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur)

Group Type OTHER

Cervical collar (Miami J collar - Össur)

Intervention Type DEVICE

The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment

12 weeks

This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur)

Group Type OTHER

Cervical collar (Miami J collar - Össur)

Intervention Type DEVICE

The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cervical collar (Miami J collar - Össur)

The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with a newly diagnosed (within 5 days of injury) fracture in vertebra C3-C7 with SLIC score 1-3
* Patients must be abel to give their consent to participate in the study

Exclusion Criteria

* Unstable cervical fractures in need of surgery
* SLIC score \>3
* Fractures of the spinous process and the transverse process in the cervical spine
* Stable fractures in in the C3-C7 vertebra combined with fractures of the C0-C2 vertebra
* Pathological fractures in the cervical spine

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No