Health TrialsbyHealthPanel

Personalized Spine Study Group (PSSG) Registry

ConditionsScoliosis; AdolescenceDegenerative Disc DiseaseSpinal FusionKyphoscoliosisPseudoarthrosis of SpineSpinal StenosisKyphoses, Scheuermann
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-85
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patient able to consent or assent

Disqualifiers

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

Trial population

Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Patient Specific Rod

    Device

    Posterior spinal fusion rod

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Patients with Personalized SpineRods1 intervention
Group B: Patient with other hardware0 interventions

Trial outcomes

Primary outcomes

1

Patient-Specific Hardware Spino-Pelvic Measurements

The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray.

Time frame
Up to 4 years

Secondary outcomes

1

Non Patient-Specific Hardware Spino-Pelvic Measurements

The study will collect clinical and radiographic outcomes of patients implanted rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray.

Time frame
1 year

Other outcomes

1

PROMIS CAT Physical Function

Questionnaire regarding physical function of subject

Time frame
Up to 4 years
2

PROMIS CAT Pain

Questionnaire regarding pain of subject

Time frame
Up to 4 years
3

PROMIS CAT Anxiety

Questionnaire regarding anxiety of subject

Time frame
Up to 4 years
4

PROMIS CAT Depression

Questionnaire regarding depression of subject

Time frame
Up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Personalized Spine Study Group

Collaborator

Source ClinicalTrials.gov
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