NCT04204135

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Oct 2018Nov 2027

Study Start

First participant enrolled

October 4, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

8.9 years

First QC Date

August 20, 2019

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

LLIF or ALIF procedures

Eligibility Criteria

AgeUp to 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing LLIF or ALIF procedures

You may qualify if:

  • , 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

You may not qualify if:

  • Older than 65 years of age
  • Prior spinal fusion surgery
  • Greater than Grade 2 spondylolisthesis
  • Greater than 10° scoliosis
  • History of spinal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpondylolisthesis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

December 18, 2019

Study Start

October 4, 2018

Primary Completion (Estimated)

September 4, 2027

Study Completion (Estimated)

November 4, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations