Skip to content

Personalized Spine Study Group Registry

Personalized Spine Study Group Registry

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03843476
Enrollment
0
Registered
2019-02-18
Start date
2014-01-31
Completion date
2020-09-30
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Kyphoscoliosis, Kyphoses, Scheuermann, Pseudoarthrosis of Spine, Scoliosis; Adolescence, Spinal Fusion, Spinal Stenosis

Brief summary

As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.

Detailed description

The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are: 1. Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events 2. Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment 3. Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables 4. Rod curvature maintenance over the follow-up period 5. Understand the post-operative risks and complications from the pre-operative condition

Interventions

Posterior spinal fusion rod

Sponsors

Medicrea, USA Corp.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
10 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patient has been/ will be operated and instrumented with PSR from Medicrea * Patient able to complete a self- administered questionnaires * Patient able to consent or assent

Exclusion criteria

* Patient unable to sign an informed consent form * Patient unable to complete a self-administered questionnaire * Patient is pregnant or planning on becoming pregnant during the duration of their study participation * Patient is older than 85 * Patient is younger than 10

Design outcomes

Primary

MeasureTime frameDescription
Data collection initiativeUp to 4 yearsThe study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.

Secondary

MeasureTime frameDescription
Collect clinical and radiographic outcomes of patients with Medicrea hardware1 yearA control cohort to the patient-specific rods

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026