An interventional study of Hard Cervical Collar in Spinal Stenosis Cervical, Radiculopathy, Cervical Region and Posterior Cervical Fusion, sponsored by Georgetown University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Georgetown University · Not applicable, Interventional, and Treatment
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients with trauma, tumors, or infections
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hard Cervical Collar for 6 weeks
Device: Hard Cervical Collar
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.
Radiographic fusion success
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
Time frame: 3, 6, 12 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months
Wound infection rate
Time frame: up to 12 months after surgery
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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