Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04601363

Conditions

Scoliosis; Adolescence

Degenerative Disc Disease

Spinal Fusion

Kyphoscoliosis

Pseudoarthrosis of Spine

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

Patient Specific Rod

Study Details

Brief summary:

The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

Conditions

Scoliosis; Adolescence

Degenerative Disc Disease

Spinal Fusion

Kyphoscoliosis

Pseudoarthrosis of Spine

Study ID

NCT04601363

Start date

Oct 29, 2020

Status verified date

Oct, 2024

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
  • 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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Personalized SpineRods

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

Patient with other hardware

Patients with other hardware not patient-specific

Interventions

Patient Specific Rod

Posterior spinal fusion rod

Primary outcome measure

  • Patient-Specific Hardware Spino-Pelvic Measurements [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Christopher Kleck, MD

720-848-1900Christopher.Kleck@CUAnschutz.edu

jiandong hao

303-724-7457jiandong.hao@cuanschutz.edu

Locations

Dr. Christopher Kleck, MD

Recruiting

Aurora, Colorado, United States, 80045

Contacts

jiandong hao

303-724-7457jiandong.hao@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 3, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-03.