Not provided
Not provided
Not provided
Not provided
Not provided
Due to COVID-19 disruption
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| VB Spine, LLC | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tritanium Posterior Lumbar Cage | Experimental | Surgical placement of the Tritanium Posterior Lumbar Cage |
|
| AVS PEEK UniLIF | Active Comparator | Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanium Posterior Lumbar Cage | Device | Placement of Tritanium Posterior Lumbar Cage via TLIF procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fusion Success | CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale | Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain. | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
Not provided
Inclusion Criteria:
Subject is skeletally mature
Subject has one or more of the following diagnoses:
Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1
a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s)
Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion
Subject has received 6 months of non-operative therapy
Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
Subject agrees to comply with visit schedule and study assessments
Provision of signed and dated informed consent form
Subject stated willingness to comply with all study procedures and availability for the duration of the study
Subject is in good general health as evidenced by medical history
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Zipsie | Riverside Medical Center | Study Director |
| Juan Jimenez, MD | Riverside Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Medical Center | Kankakee | Illinois | 60901 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tritanium Posterior Lumbar Cage | Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure |
| FG001 | AVS PEEK UniLIF | Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AVS PEEK UniLIF | Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. Study not completed due to COVID-19 |
| BG001 | Tritanium Posterior Lumbar Cage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Fusion Success | CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint | Four patients were initially enrolled; however, due to COVID-19, study enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No data to analyze. | Posted | 12 Months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tritanium Posterior Lumbar Cage | Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Koehn, Clinical Research Nurse | Riverside Medical Center | 815-933-1671 | ckoehn@rhc.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Jan 14, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2018 | Jan 21, 2019 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Parallel randomized controlled trial
Not provided
Not provided
Study participants will not know which posterior lumbar cage they receive.
| AVS UniLIF PEEK Posterior Lumbar Cage | Device | Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. |
|
| Change in Low Back Function | Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled). | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
| Change in Quality of Life: SF-36 PCS | Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function). | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation. |
| Number of Participants That Return to Work | Subjects who were unable to work due to their back pain who return to work. | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
| Ambulatory Status | Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline. | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
| Number of Participants With Serious Adverse Events | Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation | 6 weeks; 3 months; 6 months; and 12 months post operation |
| Change in Quality of Life: EQ-5d | Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health. | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure Study not completed due to COVID-19. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Data collection was not completed as the study did not progress due to COVID-19 | The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze. | Count of Participants | Participants |
|
Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
| OG001 | Tritanium Posterior Lumbar Cage | Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure |
|
| Secondary | Change in Visual Analogue Scale | Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain. | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| Secondary | Change in Low Back Function | Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled). | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| Secondary | Change in Quality of Life: SF-36 PCS | Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function). | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation. |
|
|
| Secondary | Number of Participants That Return to Work | Subjects who were unable to work due to their back pain who return to work. | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| Secondary | Ambulatory Status | Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline. | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| Secondary | Number of Participants With Serious Adverse Events | Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| Secondary | Change in Quality of Life: EQ-5d | Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health. | Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze | Posted | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | AVS PEEK UniLIF | Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided