Personalized Spine Study Group Registry

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.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spinal Fusion; Kyphoscoliosis; Scoliosis; Adolescence; Pseudoarthrosis of Spine; Kyphoses, Scheuermann
• Intervention / Treatment: Device: Patient Specific Rod

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

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient is being implanted with patient specific rod

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical with Rod; The patient is being treated with the patient specific rod with a surgery date planned	Device: Patient Specific Rod; Posterior spinal fusion rod; Other Names: UNiD Rod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data collection initiative	The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect clinical and radiographic outcomes of patients with Medicrea hardware	A control cohort to the patient-specific rods	1 year

Collaborators and Investigators

• Sponsor: Medicrea, USA Corp.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Osteochondrosis; Fractures, Ununited; Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Kyphosis; Scheuermann Disease; Spinal Osteochondrosis; Pseudarthrosis
• Other Study ID Numbers: 1510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared with the other investigators in the group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No