XLIF Decade Plate System Study

Degenerative Disc Disease Clinical Trial

Official title:

A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® XLIF Decade™ Plate System for the Treatment of Patients With Pathologic Conditions of the Thoracic and/or Lumbar Spine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689880
• Other study ID #: NUVA.DEC0820
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2023
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.

Description:

This study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the XLIF Decade Plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. Consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. Eligible patients include those with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo XLIF surgery with lateral plating using the Decade Plate. At least 75 subjects will be enrolled and will be followed for 24 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are =18 years of age at the time of consent

2. Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for

1. degenerative disc disease

2. spondylolisthesis

3. scoliosis, kyphosis, lordosis

4. spinal stenosis

5. spondylolysis

6. pseudoarthrosis or failed previous spine surgery

3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment

4. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study

2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)

3. Use of bone growth stimulators postoperatively

4. Active smoking within 6 weeks before surgery

5. Patient has known sensitivity to materials implanted

6. Systemic or local infection (latent or active) or signs of local inflammation

7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment

8. Pregnant, or plans to become pregnant during the study

9. Patient is a prisoner

10. Patient is participating in another clinical study that would confound study data

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Scoliosis
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Scoliosis
• Spondylolisthesis

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication of interbody implant	Rate of device-related complications (i.e., safety) attributable to the use of the Decade Plate System	24 months
Primary	Radiographic fusion success	Proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).	Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.	Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability.	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Secondary	Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for back/leg pain measured by visual analog scale (VAS).	Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points or less, at least a 2.5 point improvement, or at least a 41.4% improvement) where 0 is "No Pain" and 10 is "Unbearable Pain".	24 months
Secondary	Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the Oswestry disability index.	Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet SCB (at least 18.8 point improvement, at least a 36.8% improvement, or a disability value below 31.3) where a higher score on the ODI indicates a more severe disability.	24 months
Secondary	Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (7 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Secondary	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies	24 months