Personalized Spine Study Group Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Surgical with Rod

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

Patient Specific Rod

Intervention Type DEVICE

Posterior spinal fusion rod

Interventions

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Patient Specific Rod

Posterior spinal fusion rod

Intervention Type DEVICE

Other Intervention Names

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UNiD Rod

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No