Personalized Spine Study Group Registry

NCT03843476 | Withdrawn FDA Device

• 1 other identifier: 1510
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Data collection initiative

  The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.

  Up to 4 years

Secondary Outcomes (1)

• Collect clinical and radiographic outcomes of patients with Medicrea hardware

  1 year

Study Arms (1)

Surgical with Rod

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

Device: Patient Specific Rod

Interventions

Patient Specific Rod DEVICE

Posterior spinal fusion rod

Also known as: UNiD Rod

Surgical with Rod

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient is being implanted with patient specific rod

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea, USA Corp.: lead

MeSH Terms

Conditions

Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Scheuermann Disease

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Osteochondrosis; Osteochondrosis; Kyphosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 18, 2019
• Study Start: January 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share