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CopiOs Posterolateral Fusion Procedure

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ClinicalTrials.gov Identifier: NCT01123850
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 14, 2010
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Spondylolisthesis Stenosis Device: Copios Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Fusion Assessment [ Time Frame: 6 M, 12 M ]
    Fusion at 12M using radiograph Fusion Mass at 12M using CT


Secondary Outcome Measures :
  1. Outcome Measure - Pain, Life Quality, Satisfaction [ Time Frame: PreOp, Surgery, 6M, 12M ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123850


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01123850     History of Changes
Other Study ID Numbers: 2008-001
First Posted: May 14, 2010    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Zimmer Biomet:
CopiOs
Degenerative spondylolisthesis,
stenosis with instability, or
degenerative disc disease as diagnosed by radicular signs and/or imaging studies

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases