Personalized Spine Study Group Registry

Degenerative Disc Disease Clinical Trial

Official title:

Personalized Spine Study Group Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03843476
• Other study ID #: 1510
• Status: Withdrawn
• Start date: January 2014
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Medicrea, USA Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Kyphoscoliosis
• Kyphoses, Scheuermann
• Kyphosis
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Scheuermann Disease
• Scoliosis
• Scoliosis; Adolescence
• Spinal Fusion
• Spinal Osteochondrosis
• Spinal Stenosis

Intervention

Device:
• Patient Specific Rod
Posterior spinal fusion rod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea, USA Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection initiative	The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.	Up to 4 years
Secondary	Collect clinical and radiographic outcomes of patients with Medicrea hardware	A control cohort to the patient-specific rods	1 year