Low Back PainNCT05201573
DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
An observational study of Low Back Pain, run by Companion Spine, LLC.
Trial summary
A hybrid prospective/retrospective, multicenter, single-arm, data collection study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Observational
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2022to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data will be collected from up to 8 sites that participated in the DIAM Pivotal Study. There is no randomization for this study. The goal is to collect long-term follow-up data on patients who participated in the DIAM™Spinal Stabilization System - Pivotal Study and were randomized to the DIAM arm or who were randomized to the control arm AND crossed over to receive DIAM treatment.
Who may be able to join
- Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
- Willing and able to consent to study procedures
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet.
About this study
A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
Read the detailed description
Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.
Data collected at one-time point from subjects with at least 5 years of follow-up data.
- Conditions
- Low Back Pain
- Being tested
- Observational
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is an observational study of long term follow up data for patients who previously received the DIAM implant
| Study group | Role | What they receive |
|---|---|---|
| Subjects historically treated with DIAM | Subjects randomized to the DIAM arm and treated with the DIAM™ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety associated with the use of the investigational implant during long term follow up
The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up.
Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.
Measured: 5-10 years after implantation
Secondary outcomes (4)
Back Pain evaluation
Composite overall success consisting of:
Pain/disability (Oswestry) success (≥15 pt. improvement relative to baseline) No serious adverse event is classified as "implant-associated", "procedure associated" or "implant-/surgical procedure associated." No additional surgical procedure at the involved level is classified as a failure.
Measured: 5-10 years after implantation
Back Pain evaluation
Change in back pain score compared to baseline
Measured: 5-10 years after implantation
Back Pain evaluation
Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency)
Measured: 5-10 years after implantation
Back Pain evaluation
SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0
Measured: 5-10 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start17 Jan 2022 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Companion Spine, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201573
- Sponsor's protocol ID
- CP21001
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
- ClinicalTrials.gov ID
- NCT05201573
- Acronym / sponsor ID
- CP21001
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Companion Spine, LLCUniversity, hospital or other
- Collaborators
- MCRA
- Study start
- 17 Jan 2022 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
Detailed description
Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.
Data collected at one-time point from subjects with at least 5 years of follow-up data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects historically treated with DIAM | – | Other: ObservationalSubjects randomized to the DIAM arm and treated with the DIAM™ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data will be collected from up to 8 sites that participated in the DIAM Pivotal Study. There is no randomization for this study. The goal is to collect long-term follow-up data on patients who participated in the DIAM™Spinal Stabilization System - Pivotal Study and were randomized to the DIAM arm or who were randomized to the control arm AND crossed over to receive DIAM treatment.
Key inclusion criteria (2 listed)
- Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
- Willing and able to consent to study procedures
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| ObservationalThis is an observational study of long term follow up data for patients who previously received the DIAM implant | Other | Subjects historically treated with DIAM |
Primary outcome
Evaluate the safety associated with the use of the investigational implant during long term follow up
Time frame: 5-10 years after implantation
The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up. Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.
4 secondary outcomes
Back Pain evaluation
Time frame: 5-10 years after implantation
Back Pain evaluation
Time frame: 5-10 years after implantation
Back Pain evaluation
Time frame: 5-10 years after implantation
Back Pain evaluation
Time frame: 5-10 years after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Companion Spine, LLC.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif S Elsherif (202.552.5893, ssamy@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety associated with the use of the investigational implant during long term follow up (time frame: 5-10 years after implantation). 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 21 Jan 2022.