O-arm Assessment of Vertebral Movement Using ST2R Technique

NCT03609138 | Withdrawn FDA Device

• 1 other identifier: #0312
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.

Conditions

Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (1)

• Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients

  4 years

Secondary Outcomes (1)

• Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data

  4 years

Study Arms (1)

Study Cohort

Device: Spinal Hardware

Interventions

Spinal Hardware DEVICE

Pedicle screws and patient specific rods

Study Cohort

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with adolescent idiopathic scoliosis undergoing fusion surgery

You may qualify if:

• Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
• Age between 10 and 21
• Lenke Type 1 curve
• Consent and Assent to participate in the study

You may not qualify if:

• Age superior to 21 years
• Spinal deformities other than Lenke 1 type
• Use of implant other than those from the PASS LP system or sublaminar bands
• Neuromuscular or degenerative scoliosis
• Spinal cord abnormalities with any neurologic symptoms or signs
• Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
• Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma)
• Primary abnormalities of bones (e.g. osteogenesis imperfect)
• Congenital Scoliosis
• Scoliosis requiring anterior release
• Previous spinal surgery
• Absence of required preoperative data (diagnosis, consent…)

Sponsors & Collaborators

• Medicrea, USA Corp.: lead

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11