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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):
Zimmer Biomet

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Spondylolisthesis
Stenosis
Intervention Device: Copios
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single ARM - Copios Bone Filler
Hide 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
Reason Not Completed
Slow enrollment             45
Arm/Group Title Single ARM - Copios Bone Filler
Hide 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 Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
45
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female NA [1] 
Male NA [1] 
[1]
Study was terminated for slow enrollment. Data was not analysed.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title Fusion Assessment
Hide Description Fusion at 12M using radiograph Fusion Mass at 12M using CT
Time Frame 6 M, 12 M
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated due to slow enrollment, there was no data analysis
Arm/Group Title Single ARM - Copios Bone Filler
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Outcome Measure - Pain, Life Quality, Satisfaction
Hide Description [Not Specified]
Time Frame PreOp, Surgery, 6M, 12M
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated due to slow enrollment, there was no data analysis
Arm/Group Title Single ARM - Copios Bone Filler
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single ARM - Copios Bone Filler
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single ARM - Copios Bone Filler
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single ARM - Copios Bone Filler
Affected / at Risk (%)
Total   0/45 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Herdrich
Organization: Zimmer
Phone: 952-830-6224
EMail: laura.herdrich@zimmer.com
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01123850     History of Changes
Other Study ID Numbers: 2008-001
First Submitted: May 12, 2010
First Posted: May 14, 2010
Results First Submitted: April 24, 2015
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015