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Enrolling by invitation NCT04204135

The Course of Hip Flexion Weakness Following LLIF or ALIF

Observational Degenerative Disc Disease Herniated Nucleus Pulposus Spondylolisthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LLIF or ALIF procedures.
Who it may be relevant to
Registry conditions: Degenerative Disc Disease, Herniated Nucleus Pulposus, Spondylolisthesis. Basic parameters: up to 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure LLIF or ALIF procedures
    LLIF or ALIF procedures

Primary outcome measures

  • Hip flexion and knee extension strength as measured by the Lafayette Instrument Manual Muscle Testing Device (Dynamometer). [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT04204135 · 16081205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗