Personalized Spine Study Group Registry

Medicrea

Status: Withdrawn

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

Treatments: Device: Patient Specific Rod

Study type: Observational

Funder types: Industry

Identifiers

NCT03843476

1510

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 10 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Surgical with Rod

Description:

The patient is being treated with the patient specific rod with a surgery date planned

Treatment:

Device: Patient Specific Rod