Fusion of Spine (Disease)NCT01750840
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
An observational study of Fusion of Spine (Disease) and Fractures, Ununited, run by Zimmer Biomet at 1 site in United States.
Trial summary
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusion of Spine (Disease), Fractures, Ununited
- What is being tested?
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System and Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2013
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications. Subjects will undergo treatment with Biomet's SpinalPak for spinal applications
Who may be able to join
- Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
- Subject has agreed to return to the physician for their physician required follow up visits.
- Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
- Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed.
Who cannot join
- Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
- Any subject not willing to complete the QoL questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Registry to Collect Patient Outcome Data for the BIOMET® EBI Bone Healing System, BIOMET® OrthoPak® Non-invasive Bone Growth Stimulator System, and the BIOMET® SpinalPak® Non-Invasive Spine Fusion Stimulator System
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
Read the detailed description
The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.
- Conditions
- Fusion of Spine (Disease), Fractures, Ununited
- Being tested
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Medical subject headings
- Disease, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomet® EBI Bone Healing SystemDevice
A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.
Biomet Orthopak® Non-Invasive Bone Growth Stimulator SystemDevice
A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
Biomet SpinalPak® Non-Invasive Spine Fusion StimulatorDevice
A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Group | All patients will receive either the Biomet® EBI Bone Healing System, Biomet OrthoPak® Non-invasive Bone Growth Stimulator System or Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator Systems. Receives: Device: Biomet® EBI Bone Healing System; Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System; Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment of Healing
Bone healing was assessed on x-rays and/or CT scan.
Measured: The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.
Secondary outcomes (1)
Quality of Life Assessment
Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.
Measured: The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Slow enrollment and poor patient follow-up following 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 Fusion of Spine (Disease)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randy Graham, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750840
- Sponsor's protocol ID
- CS-101P
- Status last verified
- Jun 2017
- First submitted
- 13 Dec 2012
- Last updated
- 19 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Registry to Collect Patient Outcome Data for the BIOMET® EBI Bone Healing System, BIOMET® OrthoPak® Non-invasive Bone Growth Stimulator System, and the BIOMET® SpinalPak® Non-Invasive Spine Fusion Stimulator System
- ClinicalTrials.gov ID
- NCT01750840
- Acronym / sponsor ID
- CS-101P
- Conditions
- Fusion of Spine (Disease), Fractures, Ununited
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment and poor patient follow-up following enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 14 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
Detailed description
The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | – | Device: Biomet® EBI Bone Healing System, Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Device: Biomet SpinalPak® Non-Invasive Spine Fusion StimulatorAll patients will receive either the Biomet® EBI Bone Healing System, Biomet OrthoPak® Non-invasive Bone Growth Stimulator System or Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator Systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications. Subjects will undergo treatment with Biomet's SpinalPak for spinal applications
Key inclusion criteria (4 listed)
- Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
- Subject has agreed to return to the physician for their physician required follow up visits.
- Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
- Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed.
Key exclusion criteria (2 listed)
- Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
- Any subject not willing to complete the QoL questionnaires.
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 |
|---|---|---|
| Biomet® EBI Bone Healing SystemA pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day. | Device | Stimulation Group |
| Biomet Orthopak® Non-Invasive Bone Growth Stimulator SystemA capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day. | Device | Stimulation Group |
| Biomet SpinalPak® Non-Invasive Spine Fusion StimulatorA capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day. | Device | Stimulation Group |
Primary outcome
Radiographic Assessment of Healing
Time frame: The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.
Bone healing was assessed on x-rays and/or CT scan.
1 secondary outcome
Quality of Life Assessment
Time frame: The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Randy Graham study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fusion of Spine (Disease) and Fractures, Ununited, run by Zimmer Biomet at 1 site 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 2 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2016). 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?
Radiographic Assessment of Healing (time frame: The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2017.