Degenerative Disc DiseaseNCT04204135
The Course of Hip Flexion Weakness Following LLIF or ALIF
An observational study of Degenerative Disc Disease and Herniated Nucleus Pulposus, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Degenerative Disc Disease, Herniated Nucleus Pulposus, Spondylolisthesis
- What is being tested?
- LLIF or ALIF procedures
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 4 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing LLIF or ALIF procedures
Who may be able to join
- 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
Who cannot join
- Older than 65 years of age
- Prior spinal fusion surgery
- Greater than Grade 2 spondylolisthesis
- Greater than 10° scoliosis
- History of spinal infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
- Being tested
- LLIF or ALIF procedures
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLIF or ALIF proceduresProcedure or surgery
LLIF or ALIF procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start4 Oct 2018
- Primary completion4 Sep 2027 (estimated)
- Study completion4 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204135
- Sponsor's protocol ID
- 16081205
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Course of Hip Flexion Weakness Following LLIF or ALIF
- ClinicalTrials.gov ID
- NCT04204135
- Acronym / sponsor ID
- 16081205
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 4 Sep 2027 (estimated)
- Study completion
- 4 Nov 2027 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing LLIF or ALIF procedures
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Older than 65 years of age
- Prior spinal fusion surgery
- Greater than Grade 2 spondylolisthesis
- Greater than 10° scoliosis
- History of spinal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLIF or ALIF proceduresLLIF or ALIF procedures | Procedure or surgery | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Herniated Nucleus Pulposus, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.