Trials / Recruiting
RecruitingNCT04601363
Personalized Spine Study Group (PSSG) Registry
Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 10 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.
Detailed description
The registry follows patient during their standard of care visits. During a standard of care visit, a study subject will be required to answer questions about themselves and fill out patient reported outcome questionnaires. Spinopelvic measurements will be collect from standard of care x-rays. This registry is observational only used to address patient outcomes sagittal profile through the pre-operative, plan and post-operative events. Rod effectiveness in conjunction with other surgical implants by fusion assessment and sagittal alignment measurements. Patient outcomes in subgroups defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables. Rod curvature maintenance during the follow-up period. Better understanding of the post-operative risks and complications from the pre-operative condition.
Conditions
- Scoliosis; Adolescence
- Degenerative Disc Disease
- Spinal Fusion
- Kyphoscoliosis
- Pseudoarthrosis of Spine
- Spinal Stenosis
- Kyphoses, Scheuermann
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patient Specific Rod | Posterior spinal fusion rod |
Timeline
- Start date
- 2020-10-29
- Primary completion
- 2030-04-01
- Completion
- 2030-04-01
- First posted
- 2020-10-23
- Last updated
- 2024-10-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04601363. Inclusion in this directory is not an endorsement.