CopiOs Posterolateral Fusion Procedure

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01123850
• Collaborator: (none)
• Enrollment: 45
• Locations: 6
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.3

Study Details

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
• Actual Enrollment: 45 participants
• Allocation: N/A
• 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: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 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 [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 [PreOp, Surgery, 6M, 12M]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Florida Hospital	Orlando	Florida	United States	32803
2	Neurological Surgery of Southern Illinois	Belleville	Illinois	United States	62226
3	Indiana Orthopedic Center	Indianapolis	Indiana	United States	46250
4	Las Cruces Orthopaedic Associates	Las Cruces	New Mexico	United States	88005
5	Upstate Bone and Joint Center	East Syracuse	New York	United States	13057
6	Scott and White Healthcare	Temple	Texas	United States	76508

Sponsors and Collaborators

• Zimmer Biomet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT01123850
• Other Study ID Numbers: 2008-001
• First Posted: May 14, 2010
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 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

Study Results

Participant Flow

Arm/Group Title	Single ARM - Copios Bone Filler
Arm/Group 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. Copios: Bone Void Filler
Period Title: Overall Study
STARTED	45
COMPLETED	0
NOT COMPLETED	45

Baseline Characteristics

Arm/Group Title	Single ARM - Copios Bone Filler
Arm/Group 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. Copios: Bone Void Filler
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	NA NaN
Male	NA NaN
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was terminated due to slow enrollment, there was no data analysis

Arm/Group Title	Single ARM - Copios Bone Filler
Arm/Group 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. Copios: Bone Void Filler
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was terminated due to slow enrollment, there was no data analysis

Arm/Group Title	Single ARM - Copios Bone Filler
Arm/Group 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. Copios: Bone Void Filler
Measure Participants	0

Adverse Events

Arm/Group Title	Single ARM - Copios Bone Filler
Arm/Group 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. Copios: Bone Void Filler
All Cause Mortality
	Single ARM - Copios Bone Filler
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single ARM - Copios Bone Filler
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Single ARM - Copios Bone Filler
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.