Lumbar Degenerative Disc DiseaseNCT01640977
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
An observational study of Lumbar Degenerative Disc Disease, run by NuVasive at 4 sites in United States.
Trial summary
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- Open PLIF (posterior lumbar interbody fusion) and MAS PLIF
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Existing clinic patients
Who may be able to join
- Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study:
- Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
- 18+ years of age at the date of written informed consent;
- Able to undergo surgery based on physical exam, medical history and surgeon judgment;
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
- Signed and dated informed consent form.
Who cannot join
- Subjects presenting with any of the following will not be included in this observational study:
- Mental or physical condition that would limit the ability to comply with study requirements;
- Spine abnormality requiring treatment at more than two levels;
- Prior surgery at operative or adjacent level(s);
- Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
- Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
- Participating in another clinical study that would confound study data.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kuether Brain and Spine
Greensboro, North Carolina, 27401
Nova Neurosurgical Brain and Spine
Greensboro, North Carolina, 27401
Scott and White Healthcare
Temple, Texas, 76508
WellSpan Orthopedics-York
York, Pennsylvania, 17405
About this study
Official title: A Prospective Non-current Concurrent Controlled Evaluation of Open and MAS® PLIF for the Treatment of Symptomatic Lumbar Degenerative Conditions
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
Read the detailed description
The objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. Perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. A total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. Patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to PLIF surgery for their conditions will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- Open PLIF (posterior lumbar interbody fusion), MAS PLIF
- Keywords
- Open PLIF, MAS PLIF, Lumbar spine
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open PLIF (posterior lumbar interbody fusion)Procedure or surgery
The PLIF procedure achieves access to the degenerated disc from the back of the spine.
MAS PLIFProcedure or surgery
The MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach.
| Study group | Role | What they receive |
|---|---|---|
| Open PLIF | The PLIF procedure achieves access to the degenerated disc from the back of the spine, and is performed through a single midline posterior incision that is typically expanded bilaterally past the facet joints to expose bony landmarks for pedicle screw fixation, which are traditionally placed in a trajectory from lateral to medial, requiring a more lateral starting point. Receives: Procedure: Open PLIF (posterior lumbar interbody fusion) | |
| MAS PLIF | The MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach, avoiding the far lateral exposure typical of the traditional PLIF. Receives: Procedure: MAS PLIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison.
Measured: 6-weeks
Secondary outcomes (2)
Clinical Outcomes
Visual analog scale (for patient self assessment of back/leg pain)
Measured: 6-weeks
Radiographic Outcomes
Radiographic assessment (AP/lateral x-rays)
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelli Howell, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640977
- Sponsor's protocol ID
- NUVA.P1001
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2012
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-current Concurrent Controlled Evaluation of Open and MAS® PLIF for the Treatment of Symptomatic Lumbar Degenerative Conditions
- ClinicalTrials.gov ID
- NCT01640977
- Acronym / sponsor ID
- NUVA.P1001
- Conditions
- Lumbar Degenerative Disc Disease
- Keywords
- Open PLIF, MAS PLIF, Lumbar spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Jul 2012 (estimated)
- 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 study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
Detailed description
The objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. Perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. A total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. Patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to PLIF surgery for their conditions will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open PLIF | – | Procedure: Open PLIF (posterior lumbar interbody fusion)The PLIF procedure achieves access to the degenerated disc from the back of the spine, and is performed through a single midline posterior incision that is typically expanded bilaterally past the facet joints to expose bony landmarks for pedicle screw fixation, which are traditionally placed in a trajectory from lateral to medial, requiring a more lateral starting point. |
| MAS PLIF | – | Procedure: MAS PLIFThe MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach, avoiding the far lateral exposure typical of the traditional PLIF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing clinic patients
Key inclusion criteria (6 listed)
- Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study:
Key exclusion criteria (7 listed)
- Subjects presenting with any of the following will not be included in this observational study:
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 |
|---|---|---|
| Open PLIF (posterior lumbar interbody fusion)The PLIF procedure achieves access to the degenerated disc from the back of the spine. | Procedure or surgery | Open PLIF |
| MAS PLIFThe MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach. | Procedure or surgery | MAS PLIF |
Primary outcome
Complications
Time frame: 6-weeks
All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison.
2 secondary outcomes
Clinical Outcomes
Time frame: 6-weeks
Radiographic Outcomes
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- sponsor websiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Kelli Howell, MS study director
NuVasive
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disc Disease, run by NuVasive at 4 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complications (time frame: 6-weeks). 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 24 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.