Clinical Trials Logo

Clinical Trial Summary

Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety


Clinical Trial Description

Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used. Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses. Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions. A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02926404
Study type Observational [Patient Registry]
Source Medicrea International
Contact
Status Terminated
Phase
Start date January 2015
Completion date October 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Active, not recruiting NCT04542577 - PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Recruiting NCT04477447 - PMCF Study on the Safety and Performance of CESPACE 3D
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Terminated NCT01461005 - A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) N/A
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Enrolling by invitation NCT04204135 - The Course of Hip Flexion Weakness Following LLIF or ALIF
Recruiting NCT05238740 - Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen® N/A
Not yet recruiting NCT02805985 - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device N/A
Completed NCT02966639 - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Active, not recruiting NCT02057744 - MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Completed NCT01711203 - The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis N/A
Completed NCT00549913 - Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) Phase 1/Phase 2
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Terminated NCT00095095 - Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device Phase 4
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Recruiting NCT05182489 - Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages N/A
Completed NCT02884440 - Transverse Abdominis Plane Block for Anterior Approach Spine Surgery Phase 2