Personalized Spine Study Group (PSSG) Registry

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04601363
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Patient Specific Rod — DEVICE
    Posterior spinal fusion rod

Study Details

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.

Key Dates

Start date
Oct 29, 2020
Status verified
Oct 2024
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patients with Personalized SpineRods
    The patient is being treated with the patient-specific rod with a surgery date planned
  • Arm: Patient with other hardware
    Patients with other hardware not patient-specific

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Christopher Kleck, MDAuroraColorado80045
jiandong hao
[email protected]
303-724-7457

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Dr. Christopher Kleck, MD· Aurora, CO

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