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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04204135
Other study ID # 16081205
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 4, 2018
Est. completion date November 4, 2025

Study information

Verified date March 2024
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the course of hip weakness after LLIF or ALIF procedures. These outcomes include measures of hip strength using a dynamometer, which is a device used to measure muscle strength. While it is known that people experience temporary hip and leg weakness after an LLIF or ALIF, the exact timing of when hip and leg strength is regained after an LLIF or ALIF is not known.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 22
Est. completion date November 4, 2025
Est. primary completion date September 4, 2025
Accepts healthy volunteers
Gender All
Age group N/A to 65 Years
Eligibility Inclusion Criteria: - 1-, 2-, or 3-level L2L3, L3L4, or L4L5 LLIF or ALIF for degenerative pathology including radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis, and scoliosis - Back and/or leg pain - Failed at least 6 months of conservative treatment Exclusion Criteria: - Older than 65 years of age - Prior spinal fusion surgery - Greater than Grade 2 spondylolisthesis - Greater than 10° scoliosis - History of spinal infection

Study Design


Intervention

Procedure:
LLIF or ALIF procedures
LLIF or ALIF procedures

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hip flexion and knee extension strength as measured by the Lafayette Instrument Manual Muscle Testing Device (Dynamometer). Using a Lafayette Instrument Manual Muscle Testing Device (Dynamometer), we will be measuring the force in pounds a given patient can exert upon hip flexion and knee extension at the preoperative timepoint and 6 weeks, 12 weeks and 6 months postoperatively. Assessing changes in hip flexion and leg extension strength from the preoperative baseline to postoperative measurements taken at 6 weeks, 12 weeks and 6 months following lumbar fusions.
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