Status:
RECRUITING
Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy (FAST-PT)
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Cervical Spine Degeneration
ACDF Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
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 s...
Detailed Description
This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degener...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06202443
Start Date
February 1 2024
End Date
July 31 2027
Last Update
September 3 2025
Active Locations (4)
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1
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
3
Booke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
4
Madigan Army Medical Center
Tacoma, Washington, United States, 98431