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Personalized Spine Study Group Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843476
Recruitment Status : Withdrawn (Requested by surgeons to pursue new study)
First Posted : February 18, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Medicrea, USA Corp.

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.

Condition or disease Intervention/treatment
Scoliosis; Adolescence Degenerative Disc Disease Spinal Fusion Kyphoscoliosis Pseudoarthrosis of Spine Spinal Stenosis Kyphoses, Scheuermann 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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Personalized Spine Study Group Registry
Actual Study Start Date : January 2014
Actual Primary Completion Date : September 2020
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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 Name: UNiD Rod




Primary Outcome Measures :
  1. Data collection initiative [ Time Frame: Up to 4 years ]
    The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.


Secondary Outcome Measures :
  1. Collect clinical and radiographic outcomes of patients with Medicrea hardware [ Time Frame: 1 year ]
    A control cohort to the patient-specific rods



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient is being implanted with patient specific rod
Criteria

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
Additional Information:

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Responsible Party: Medicrea, USA Corp.
ClinicalTrials.gov Identifier: NCT03843476    
Other Study ID Numbers: 1510
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared with the other investigators in the group

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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
Additional relevant MeSH terms:
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Scoliosis
Spinal Stenosis
Intervertebral Disc Degeneration
Kyphosis
Scheuermann Disease
Spinal Osteochondrosis
Pseudarthrosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Osteochondrosis