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
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.
- 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