WithdrawnNot Applicable

Personalized Spine Study Group Registry

Stopped: Requested by surgeons to pursue new study

0Started 2014-01

Plain-language 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.

Who can participate

Age range10 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Data collection initiative

Timeframe: Up to 4 years

Trial details

NCT IDNCT03843476

SponsorMedicrea, USA Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-09

View on ClinicalTrials.gov More Scoliosis; Adolescence trials