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CopiOs Posterolateral Fusion Procedure

Primary Purpose

Spondylolisthesis, Stenosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Copios
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylolisthesis focused on measuring CopiOs, Degenerative spondylolisthesis,, stenosis with instability, or, degenerative disc disease as diagnosed by radicular signs and/or imaging studies

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Hospital
  • Neurological Surgery of Southern Illinois
  • Indiana Orthopedic Center
  • Las Cruces Orthopaedic Associates
  • Upstate Bone and Joint Center
  • Scott and White Healthcare

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Single ARM - Copios Bone Filler

Arm Description

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.

Outcomes

Primary Outcome Measures

Fusion Assessment
Fusion at 12M using radiograph Fusion Mass at 12M using CT

Secondary Outcome Measures

Outcome Measure - Pain, Life Quality, Satisfaction

Full Information

First Posted
May 12, 2010
Last Updated
May 11, 2015
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01123850
Brief Title
CopiOs Posterolateral Fusion Procedure
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolisthesis, Stenosis
Keywords
CopiOs, Degenerative spondylolisthesis,, stenosis with instability, or, degenerative disc disease as diagnosed by radicular signs and/or imaging studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single ARM - Copios Bone Filler
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Copios
Intervention Description
Bone Void Filler
Primary Outcome Measure Information:
Title
Fusion Assessment
Description
Fusion at 12M using radiograph Fusion Mass at 12M using CT
Time Frame
6 M, 12 M
Secondary Outcome Measure Information:
Title
Outcome Measure - Pain, Life Quality, Satisfaction
Time Frame
PreOp, Surgery, 6M, 12M

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Neurological Surgery of Southern Illinois
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Indiana Orthopedic Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Las Cruces Orthopaedic Associates
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88005
Country
United States
Facility Name
Upstate Bone and Joint Center
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Scott and White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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CopiOs Posterolateral Fusion Procedure

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