NCT06202443 Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
| NCT ID | NCT06202443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Cervical Spine Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2024-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery. The main question this clinical trial aims to answer are: * Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants. * Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes. Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.
Eligibility Criteria
Inclusion Criteria: * Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure; * English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and * Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF) Exclusion Criteria: * Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity; * Undergoing cervical corpectomy; * Prior history of cervical spine surgery in last 5 years; * Diagnosis or presence of osteoporosis; * Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder; * Documented history of alcohol and/or drug abuse; * Currently involved in litigation due to injury; * Currently undergoing treatment for cancer; * Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and * Unable to provide a stable telephone or physical address
Contact & Investigator
Kristin Archer, PhD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06202443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cervical Spine Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06202443 currently recruiting?
Yes, NCT06202443 is actively recruiting participants. Contact the research team at amanda.priest@vumc.org for enrollment information.
Where is the NCT06202443 trial being conducted?
This trial is being conducted at Honolulu, United States, Nashville, United States, Fort Sam Houston, United States, Tacoma, United States.
Who is sponsoring the NCT06202443 clinical trial?
NCT06202443 is sponsored by Vanderbilt University Medical Center. The principal investigator is Kristin Archer, PhD at Vanderbilt University Medical Center. The trial plans to enroll 76 participants.