UNiD Rods Register

Status Terminated

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

Clinical Trial Details

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

View Details

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	`NCT02931279` - PASS OCT® Post-market Clinical Follow-up
Completed	`NCT02966639` - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
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