Trial Outcomes & Findings for CopiOs Posterolateral Fusion Procedure (NCT NCT01123850)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

6 M, 12 M

Results posted on

2015-05-27

Participant milestones
Measure	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. Copios: Bone Void Filler
Overall Study STARTED	45
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	45

Reasons for withdrawal
Measure	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. Copios: Bone Void Filler
Overall Study Slow enrollment	45

CopiOs Posterolateral Fusion Procedure

Baseline characteristics by cohort
Measure	Single ARM - Copios Bone Filler n=45 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

Timeframe: 6 M, 12 M

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

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

Outcome data not reported

Timeframe: PreOp, Surgery, 6M, 12M

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

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Zimmer

Phone: 952-830-6224