CopiOs Posterolateral Fusion Procedure

Status Terminated

Clinical Trial Summary

To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.

Clinical Trial Description

This is a prospective, counter-balanced study involving 85 subjects at up to 8 investigative centers. Each subject will be an appropriate candidate for an instrumented PLF and will meet the inclusion and exclusion criteria. All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study. Data will be collected pre-operatively, operatively and post-operatively at six and twelve months.

The study objectives include: Radiographic success of CopiOs is non-inferior to autograft with clear evidence of bridging bone. Radiographic analysis will be used to show that CopiOs works as well as autograft when comparing the rate of fusion at 6 and 12 months. The CT scan (12 month) will show that CopiOs works as well as autograft when comparing the fusion mass between the transverse processes. Additionally, clinical success will be determined by an improvement of 15 percentage points using the Oswestry Disability Index and maintenance or improvement in the motor and sensory components of the neurological assessment from preoperative to postoperative. Since patients serve as self-controls there will be no clinical success comparisons between the groups. Rather, clinical success will be measured on overall improvement based on patient outcomes. ;

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01123850
Study type	Interventional
Source	Zimmer, Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	June 2010
Completion date	October 2012

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
Completed	`NCT02966639` - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Completed	`NCT02931279` - PASS OCT® Post-market Clinical Follow-up
Not yet recruiting	`NCT02805985` - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device	N/A
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.