NCT07789288

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Dec 2028

Study Start

First participant enrolled

June 3, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Spinal Stenosis CervicalRadiculopathy, Cervical RegionPosterior Cervical FusionSpondylosis, Cervical

Outcome Measures

Primary Outcomes (1)

  • Radiographic fusion success

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

    3, 6, 12 months after surgery

Secondary Outcomes (6)

  • Neck Disability Index (NDI)

    Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery

  • EQ-5D Quality of Life

    Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

  • Numeric Rating Scale (NRS) for Neck Pain

    Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

  • Numeric Rating Scale (NRS) for Arm Pain

    Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months

  • North American Spine Society (NASS) Patient Satisfaction Index

    6 weeks, 12 weeks, 6 months, and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Collar

EXPERIMENTAL

Hard Cervical Collar for 6 weeks

Device: Hard Cervical Collar

No collar

NO INTERVENTION

Interventions

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.

Collar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Patients with trauma, tumors, or infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MedStar Georgetown University Hospital

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

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

MeSH Terms

Conditions

RadiculopathySpondylosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Amjad Anaizi, MD

CONTACT

301-856-2323Amjad.N.Anaizi@gunet.georgetown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurosurgery at MedStar Georgetown University Hospital

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

June 3, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations

US(2)