Hard Cervical Collar Use Following Posterior Cervical Fusion

August 24, 2026 updated by: Amjad Anaizi, Georgetown University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
      • Washington D.C., District of Columbia, United States, 22209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Patients with trauma, tumors, or infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collar
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.
No Intervention: No collar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic fusion success
Time Frame: 3, 6, 12 months after surgery
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
3, 6, 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI)
Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery
Patient-reported neck disability measured using the Neck Disability Index survey
Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery
EQ-5D Quality of Life
Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Patient-reported survey
Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale (NRS) for Neck Pain
Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Patient-reported survey
Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale (NRS) for Arm Pain
Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Patient-reported survey
Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
North American Spine Society (NASS) Patient Satisfaction Index
Time Frame: 6 weeks, 12 weeks, 6 months, and 12 months
Patient-reported survey
6 weeks, 12 weeks, 6 months, and 12 months
Wound infection rate
Time Frame: up to 12 months after surgery
up to 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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