The Course of Hip Flexion Weakness Following LLIF or ALIF

Degenerative Disc Disease Clinical Trial

Official title:

The Course of Hip Flexion Weakness Following LLIF or ALIF

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04204135
• Other study ID #: 16081205
• Status: Enrolling by invitation
• 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
• 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
• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Herniated Nucleus Pulposus
• Intervertebral Disc Degeneration
• Spondylolisthesis

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.