The Course of Hip Flexion Weakness Following LLIF or ALIF

• Conditions: Degenerative Disc Disease; Herniated Nucleus Pulposus; Spondylolisthesis

• Registration Number: NCT04204135
• Lead Sponsor: Rush University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-09-04
• Study Completion: 2025-11-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hip flexion and knee extension strength as measured by the Lafayette Instrument Manual Muscle Testing Device (Dynamometer).	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.	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States