SpondylolisthesisPhase 2NCT01123850

CopiOs Posterolateral Fusion Procedure

A Phase 2 study testing Copios in people with Spondylolisthesis and Stenosis, run by Zimmer Biomet at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Spondylolisthesis, Stenosis
What is being tested?: Copios
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 6 sitesUnited States
Study dates: Jun 2010to Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

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).

Read the 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.

Conditions: Spondylolisthesis, Stenosis
Being tested: Copios
Keywords: CopiOs, Degenerative spondylolisthesis,, stenosis with instability, or, degenerative disc disease as diagnosed by radicular signs and/or imaging studies
Medical subject headings: Spondylolisthesis, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CopiosDevice
Bone Void Filler

Study groups in NCT01123850
Study group	Role	What they receive
Single ARM - Copios Bone Filler	Active comparator	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. Receives: Device: Copios

What is being measured

The primary outcome is the main question the study is designed to answer.

Fusion Assessment
Fusion at 12M using radiograph Fusion Mass at 12M using CT
Measured: 6 M, 12 M

Secondary outcomes (1)

Outcome Measure - Pain, Life Quality, Satisfaction
Measured: PreOp, Surgery, 6M, 12M

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Oct 2012

First posted14 May 2010 (estimated)
Study startJun 2010
Primary completionOct 2012
Study completionOct 2012

Why it stopped: Slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SpondylolisthesisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01123850
Sponsor's protocol ID: 2008-001
Status last verified: May 2015
First submitted: 12 May 2010
Last updated: 27 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
Active, not recruiting
The NORDSTEN Study - Degenerative Spondylolisthesis
Lumbar Degenerative Spondylolisthesis
Enrolling by invitationObservational study
The Course of Hip Flexion Weakness Following LLIF or ALIF
Degenerative Disc Disease, Herniated Nucleus Pulposus

All Spondylolisthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT01123850
Acronym / sponsor ID: 2008-001
Conditions: Spondylolisthesis, Stenosis
Keywords: CopiOs, Degenerative spondylolisthesis,, stenosis with instability, or, degenerative disc disease as diagnosed by radicular signs and/or imaging studies
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 45 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 14 May 2010 (estimated)
Results: Posted 27 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single ARM - Copios Bone Filler	Active comparator	Device: CopiosAll 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.

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CopiosBone Void Filler	Device	Single ARM - Copios Bone Filler

Primary outcome

Fusion Assessment
Time frame: 6 M, 12 M
Fusion at 12M using radiograph Fusion Mass at 12M using CT

1 secondary outcome

Outcome Measure - Pain, Life Quality, Satisfaction
Time frame: PreOp, Surgery, 6M, 12M

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single ARM - Copios Bone Filler	45	0

Primary outcome: Fusion Assessment

Time frame: 6 M, 12 M

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single ARM - Copios Bone Filler	0 of 45 (0%)	0 of 45 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Spondylolisthesis

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
Active, not recruiting
The NORDSTEN Study - Degenerative Spondylolisthesis
Lumbar Degenerative Spondylolisthesis
Enrolling by invitationObservational study
The Course of Hip Flexion Weakness Following LLIF or ALIF
Degenerative Disc Disease, Herniated Nucleus Pulposus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Copios in people with Spondylolisthesis and Stenosis, run by Zimmer Biomet at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion Assessment (time frame: 6 M, 12 M). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01123850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.