CopiOs Posterolateral Fusion Procedure

A Prospective Study Assessing Clinical Outcomes and Radiographic Results After the Use of CopiOs(R) Bone Void Filler (BVF)Sponge in a Posterolateral Fusion Procedure (PLF).

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.

Study Overview

• Status: Terminated
• Conditions: Spondylolisthesis; Stenosis
• Intervention / Treatment: Device: Copios

Detailed 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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Belleville, Illinois, United States, 62226
      • Neurological Surgery of Southern Illinois
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Indiana Orthopedic Center
  • New Mexico
    • Las Cruces, New Mexico, United States, 88005
      • Las Cruces Orthopaedic Associates
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Bone and Joint Center
  • Texas
    • Temple, Texas, United States, 76508
      • Scott and White Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient must be skeletally mature; between the ages of 21 and 75
• Patients having degenerative spondylolisthesis, stenosis with instability, or degenerative disc disease as diagnosed by radicular signs and/or imaging studies
• Patients will be medically indicated for a single-level, instrumented PLF between L2 and S1 per their surgeon
• Patient must be willing and able to comply with study requirements, including all necessary study related paperwork and follow-up visits

Exclusion Criteria:

• Use of iliac crest bone graft;
• Any previous lumbar spinal surgeries at indicated level;
• Any medical or physical condition that would preclude the potential benefit of spinal surgery;
• Use of a dynamic stabilization systems;
• Sites where stresses on void will exceed the load strength of fixation of hardware;
• Segmental defects;
• Significantly impaired vascularity proximal to the surgical site;
• Sites in direct contact with articular space;
• Soft tissue deficit not allowing closure;
• Active systemic or local infection;
• Severe degenerative bone disease;
• Patients with osteoporosis who are actively under treatment;
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40 kg/m2);
• Active malignancy;
• Patients with a history of multiple allergies;
• Patients with known allergies to bovine collagen;
• Hypercalcemia;
• Pregnancy;
• Mental illness;
• Alcohol or drug abuse;
• Incarceration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Single ARM - Copios Bone Filler; 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.

Device: Copios; Bone Void Filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Assessment	Fusion at 12M using radiograph Fusion Mass at 12M using CT	6 M, 12 M

Secondary Outcome Measures

Outcome Measure	Time Frame
Outcome Measure - Pain, Life Quality, Satisfaction	PreOp, Surgery, 6M, 12M

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: CopiOs; Degenerative spondylolisthesis,; stenosis with instability, or; degenerative disc disease as diagnosed by radicular signs and/or imaging studies
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 2008-001