Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Osteochondrosis, Spinal Osteophytosis, Spinal Stenosis, Spondylitis, Spondylosis
Conditions
Keywords
Spine surgery, Proprio, Spine Measurement, Adults, Posterior Spine Surgery, Spine Fusion, Thoracic Spine Surgery, Lumbar Spine Surgery, Sacral Spine Surgery
Brief summary
This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries. Objectives Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively. Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes. Hypothesis The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.
Detailed description
Patient reported outcomes data will be collected on two separate forms- the Oswestry Disability Index (ODI) and the SF-36. The ODI has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. The SF-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. Study data will be compared to historical literature data. The intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio. Patients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).
Interventions
DEVICEIntraoperative spinal measurement system
The design is a prospective study to evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery.
Sponsors
Duke University
Proprio Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 years or older at the time of surgery * Type of Surgery: Consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study
Exclusion criteria
* Patients treated for traumatic injury (penetrating injuries, etc.) * Incarcerated persons * Pregnant females * Any patient current in another trial for a new implant or technique * Non-Spine Related Surgeries: Patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine) * Patients having additional surgery occurring concurrently with spine surgery * Patients ineligible for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees | Pre-operative planned state (enrollment), Postoperative final state (12 months) | Effectiveness of the intraoperative spinal measurement tool will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes as measured by the Oswestry Disability Index (ODI) | Enrollment to 24 months post-operatively | The Oswestry Disability Index (ODI) measures disability in daily living associated with low back pain. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. |
| Patient Reported Outcomes as measured by the 36-Item Short Form Survey (SF-36) | Enrollment to 24 months post-operatively | The SF-36 measures health-related quality of life across eight domains, each scored 0-100 (higher = better health). Two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived. |
| Number of secondary surgeries | Enrollment to 24 months post-operatively | Number of secondary surgeries will be collected through the electronic health record and from the patient to capture any surgery performed outside Duke. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrett Rocos, MD
Duke University
Outcome results
None listed