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NCT Number: NCT07789288

Hard Cervical Collar Use Following Posterior Cervical Fusion

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hard Cervical Collar

Device

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.

Primary outcomes

  1. Radiographic fusion success

    Time frame: 3, 6, 12 months after surgery

    Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation

Secondary outcomes

  1. 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

  2. EQ-5D Quality of Life

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

    Patient-reported survey

  3. Numeric Rating Scale (NRS) for Neck Pain

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

    Patient-reported survey

  4. Numeric Rating Scale (NRS) for Arm Pain

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

    Patient-reported survey

  5. North American Spine Society (NASS) Patient Satisfaction Index

    Time frame: 6 weeks, 12 weeks, 6 months, and 12 months

    Patient-reported survey

  6. Wound infection rate

    Time frame: up to 12 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Amjad Anaizi, MD

CONTACT

[email protected]

301-856-2323

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

Impact of a Hard Cervical Collar Versus No Cervical Collar on Recovery Outcomes Following Posterior Cervical Fusion: A Prospective Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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