Spinal Stenosis CervicalNCT07789288
Hard Cervical Collar Use Following Posterior Cervical Fusion
A study testing Hard Cervical Collar in people with Spinal Stenosis Cervical and Radiculopathy, Cervical Region, run by Georgetown University at 2 sites in United States.
Trial summary
Postoperative immobilization with a hard cervical collar following posterior cervical fusion remains common practice despite limited evidence demonstrating improved clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Cervical, Radiculopathy, Cervical Region, Posterior Cervical Fusion
- What is being tested?
- Hard Cervical Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of degenerative disk disease (DDD)
- Ability to provide informed consent
- Patients with cervical spondylotic myelopathy, cervical deformity, or pseudoarthrosis
Who cannot join
- Patients with trauma, tumors, or infections
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Min Ji Koh contact
United States2 sites, 2 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Amjad Anaizi, MD, 301-856-2323, Amjad.N.Anaizi@gunet.georgetown.edu
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 22209
Amjad Anaizi, MD, 301-856-2323, Amjad.N.Anaizi@gunet.georgetown.edu
About this study
Official title: Impact of a Hard Cervical Collar Versus No Cervical Collar on Recovery Outcomes Following Posterior Cervical Fusion: A Prospective Study
Postoperative immobilization with a hard cervical collar following posterior cervical fusion remains common practice despite limited evidence demonstrating improved clinical outcomes. This is a prospective, multi-site, randomized clinical trial evaluating postoperative hard cervical collar use following posterior cervical fusion for degenerative cervical spine disease. Eligible patients will be randomized to either wear an FDA-approved hard cervical collar (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) for 6 weeks after surgery or receive no cervical collar. Patient-reported outcomes will be collected before surgery and at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. The primary outcome is radiographic fusion success at 12 months. Secondary outcomes include neck disability, neck and arm pain, quality of life, patient satisfaction, wound infection, adverse events, and other postoperative complications. Radiographic fusion will be evaluated by blinded radiologists. The results of this study will help determine whether routine postoperative cervical collar use improves outcomes following posterior cervical fusion.
- Conditions
- Spinal Stenosis Cervical, Radiculopathy, Cervical Region, Posterior Cervical Fusion, Spondylosis, Cervical
- Being tested
- Hard Cervical Collar
- Medical subject headings
- Radiculopathy, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hard Cervical CollarDevice
Participants randomized to this arm will wear a hard cervical collar continuously for 6 weeks following posterior cervical fusion. The collar may be briefly removed for hygiene purposes. FDA-approved cervical collars (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) will be used according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Collar | Experimental | Hard Cervical Collar for 6 weeks Receives: Device: Hard Cervical Collar |
| No collar | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic fusion success
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
Measured: 3, 6, 12 months after surgery
Secondary outcomes (6)
Neck Disability Index
Patient-reported neck disability measured using the Neck Disability Index (NDI). Scores range from 0 to 50, with higher scores indicating greater neck-related disability.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery
EQ-5D-3L Quality of Life
Patient-reported health-related quality of life measured using the EQ-5D-3L descriptive system and EQ visual analogue scale (EQ VAS). The EQ-5D-3L assesses five dimensions of health, each with three levels of severity. The EQ VAS ranges from 0 to 100, with higher scores indicating better self-rated health.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale for Neck Pain
Patient-reported neck pain severity measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale for Arm Pain
Patient-reported arm pain severity measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
North American Spine Society Patient Satisfaction Index
Patient-reported satisfaction measured using the North American Spine Society (NASS) Patient Satisfaction Index. Scores range from 1 to 4, with lower scores indicating greater satisfaction with treatment.
Measured: 6 weeks, 12 weeks, 6 months, and 12 months
Wound infection rate
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start3 Jun 2026
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis CervicalStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amjad Anaizi, Georgetown University
- Investigators
- Amjad Anaizi, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789288
- Sponsor's protocol ID
- STUDY00009444
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hard Cervical Collar Versus No Cervical Collar on Recovery Outcomes Following Posterior Cervical Fusion: A Prospective Study
- ClinicalTrials.gov ID
- NCT07789288
- Acronym / sponsor ID
- STUDY00009444
- Conditions
- Spinal Stenosis Cervical, Radiculopathy, Cervical Region, Posterior Cervical Fusion, Spondylosis, Cervical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative immobilization with a hard cervical collar following posterior cervical fusion remains common practice despite limited evidence demonstrating improved clinical outcomes. This is a prospective, multi-site, randomized clinical trial evaluating postoperative hard cervical collar use following posterior cervical fusion for degenerative cervical spine disease. Eligible patients will be randomized to either wear an FDA-approved hard cervical collar (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) for 6 weeks after surgery or receive no cervical collar. Patient-reported outcomes will be collected before surgery and at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. The primary outcome is radiographic fusion success at 12 months. Secondary outcomes include neck disability, neck and arm pain, quality of life, patient satisfaction, wound infection, adverse events, and other postoperative complications. Radiographic fusion will be evaluated by blinded radiologists. The results of this study will help determine whether routine postoperative cervical collar use improves outcomes following posterior cervical fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collar | Experimental | Device: Hard Cervical CollarHard Cervical Collar for 6 weeks |
| No collar | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Diagnosis of degenerative disk disease (DDD)
- Ability to provide informed consent
- Patients with cervical spondylotic myelopathy, cervical deformity, or pseudoarthrosis
Key exclusion criteria (1 listed)
- Patients with trauma, tumors, or infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hard Cervical CollarParticipants randomized to this arm will wear a hard cervical collar continuously for 6 weeks following posterior cervical fusion. The collar may be briefly removed for hygiene purposes. FDA-approved cervical collars (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) will be used according to institutional practice. | Device | Collar |
Primary outcome
Radiographic fusion success
Time frame: 3, 6, 12 months after surgery
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
6 secondary outcomes
Neck Disability Index
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery
EQ-5D-3L Quality of Life
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale for Neck Pain
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale for Arm Pain
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
North American Spine Society Patient Satisfaction Index
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months
Wound infection rate
Time frame: up to 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Ji Koh contact
Amjad Anaizi, MD principal investigator
MedStar Georgetown University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hard Cervical Collar in people with Spinal Stenosis Cervical and Radiculopathy, Cervical Region, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amjad Anaizi, MD (301-856-2323, Amjad.N.Anaizi@gunet.georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic fusion success (time frame: 3, 6, 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.