Sacroiliac Joint Somatic DysfunctionCOVINCT04218838
Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction
A study testing CornerLoc SI Joint Stabilization Procedure and Intra-articular Sacroiliac Joint Steroid Injection in people with Sacroiliac Joint Somatic Dysfunction, run by CornerLoc at 1 site in United States.
Trial summary
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction
- What is being tested?
- CornerLoc SI Joint Stabilization Procedure and Intra-articular Sacroiliac Joint Steroid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 1 Jan 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
- Subject must provide written informed consent prior to any clinical study-related procedure.
- Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Subjects must meet criteria for sacroiliac joint dysfunction as determined below:
- History of persistent pain in the distribution of the sacroiliac joint despite adequate trial of physical therapy.
- NRS for pain ≥ 7 on a 0 -.10-point scale.
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- 3 of 5 provocative tests with positive findings on physical examination (SI distraction, thigh thrust, FABER, lateral compression, Gaenslen's maneuver).
- Positive response (≥75% percent pain relief) to diagnostic sacroiliac joint injection on two occasions at least one week apart.
- Baseline pain with 30-day history and PROMIS-29
Who cannot join
- Patient will not be entered into the study if they meet one of the following criteria:
- Subject is unable to provide written informed consent
- Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Subject had prior surgical fusion implanted on same side
- Subject is pregnant or nursing
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- Self-reported plan to bear children
- BMI ≥ 40
- DEXA < -2.5 (if available)
- History of microfractures
- History of compression fractures
- History of diabetes, must have A1c <8
- History of chronic steroid use
- Chronic immunosuppression
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
About this study
Official title: A Prospective, Multi-Center, Bi-Phasic Randomized Design to Compare Outcomes of the CornerLoc™ SI Joint Stabilization System and Intra-Articular Sacroiliac Joint Steroid Injection in Patients With Refractory Sacroiliac Joint Dysfunction
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.
Read the detailed description
Randomized, multicenter, open-label, randomized design to compare CornerLoc Allograft-based Sacroiliac Joint Stabilization System to Intra-articular Sacroiliac Joint Steroid Injection. Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment. The basis of the sample size and hypothesis testing for this clinical investigation will be based on the Randomization Phase.
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Being tested
- CornerLoc SI Joint Stabilization Procedure, Intra-articular Sacroiliac Joint Steroid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CornerLoc SI Joint Stabilization ProcedureDevice
CornerLoc minimally invasive SI Joint Stabilization System
Intra-articular Sacroiliac Joint Steroid InjectionDrug
Standard of Care - Steroid injection into the sacroiliac joint
| Study group | Role | What they receive |
|---|---|---|
| CornerLoc SI Joint Stabilization Group | Active comparator | Patient will receive the CornerLoc minimally invasive SI Joint Stabilization procedure. This procedure will be performed in an outpatient surgery center under local sedation or general anesthesia, and normally takes around 45 minutes. During the procedure, the physician will make two small incisions in the patient's lower back to access the SI joint, and place four small cadaveric bone grafts into the SI joint to help stabilize the SI joint. Receives: Device: CornerLoc SI Joint Stabilization Procedure |
| SI Joint Steroid Injections Group | Active comparator | Patient will receive an injection of steroid medication directly into their SI joint. The area around the SI joint will be numbed with an injection of local anesthetic and then ultrasound guidance will be used to guide the needle of steroid medication directly into the SI joint. This procedure will be performed in the physician's office or an outpatient surgery center, and normally takes around 30 minutes. Receives: Drug: Intra-articular Sacroiliac Joint Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection.
The efficacy responder rate is defined as the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Numeric Rating Scale (NRS) for Pain, from Baseline to the 6-Month Visit. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 6 months
Secondary outcomes (6)
Quality of life improvement from baseline to each follow-up visit.
PROMIS-29; Patient Reported Outcomes Measurement Information System (PROMIS) instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The seven domains cover the most relevant areas of self-reported health for the greatest majority of people with chronic illness.
The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity.
Measured: 6 months
Clinical improvement based on pain from baseline to each follow-up visit.
Numeric Rating Scale for Pain: The Numeric Rating Scale for Pain is a measure in which individuals rate their pain on an eleven point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The patient will be asked to point to the number on the Numeric Rating Scale that best represents intensity of pain.
Measured: 6 months
Clinical improvement of low back pain from baseline to each follow-up visit.
Oswestry Disability Index (ODI): The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is a tool for evaluators used to measure a patient's permanent functional disability. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). A higher score on the ODI indicates a more severe disability caused by lower back pain.
Measured: 6 months
Clinical improvement in balance and risk for falls from baseline to each follow-up visit.
Timed Up and Go" (TUG) Test: This test measures the time for a subject to get up from a chair walk 3 meters, turn around and return to the chair and sit. Time is measured in minutes and seconds. An average of two tests is used. The shorter average time indicates clinical improvement.
Measured: 6 months
Clinical improvement from baseline to each follow-up visit.
Zurich Claudication Questionnaire (ZCQps); The Zurich Claudication Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. The scale relates to symptoms over the past month. There are 12 questions for all patients, and a further 6 questions to measure treatment outcome. Decreasing scores indicates clinical improvement
Measured: 6 months
Clinical improvement based on use of medications from baseline to each follow-up visit.
Medication Use: All medications that are used prior to and during their participation in this study will be documented and monitored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start13 Aug 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Enrollment difficulties due to changes in control arm conventions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint Somatic DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CornerLoc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Fishman, MD, Principal investigator, Center for Interventional Pain & Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218838
- Sponsor's protocol ID
- COVI-0001
- Acronym
- COVI
- Status last verified
- Jun 2023
- First submitted
- 30 Dec 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Bi-Phasic Randomized Design to Compare Outcomes of the CornerLoc™ SI Joint Stabilization System and Intra-Articular Sacroiliac Joint Steroid Injection in Patients With Refractory Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT04218838
- Acronym / sponsor ID
- COVI / COVI-0001
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulties due to changes in control arm conventions
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CornerLocIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 6 Jan 2020 (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.
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.
Detailed description
Randomized, multicenter, open-label, randomized design to compare CornerLoc Allograft-based Sacroiliac Joint Stabilization System to Intra-articular Sacroiliac Joint Steroid Injection. Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment. The basis of the sample size and hypothesis testing for this clinical investigation will be based on the Randomization Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment.
| Arm | Type | Receives |
|---|---|---|
| CornerLoc SI Joint Stabilization Group | Active comparator | Device: CornerLoc SI Joint Stabilization ProcedurePatient will receive the CornerLoc minimally invasive SI Joint Stabilization procedure. This procedure will be performed in an outpatient surgery center under local sedation or general anesthesia, and normally takes around 45 minutes. During the procedure, the physician will make two small incisions in the patient's lower back to access the SI joint, and place four small cadaveric bone grafts into the SI joint to help stabilize the SI joint. |
| SI Joint Steroid Injections Group | Active comparator | Drug: Intra-articular Sacroiliac Joint Steroid InjectionPatient will receive an injection of steroid medication directly into their SI joint. The area around the SI joint will be numbed with an injection of local anesthetic and then ultrasound guidance will be used to guide the needle of steroid medication directly into the SI joint. This procedure will be performed in the physician's office or an outpatient surgery center, and normally takes around 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
Key exclusion criteria (14 listed)
- Patient will not be entered into the study if they meet one of the following criteria:
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 |
|---|---|---|
| CornerLoc SI Joint Stabilization ProcedureCornerLoc minimally invasive SI Joint Stabilization System | Device | CornerLoc SI Joint Stabilization Group |
| Intra-articular Sacroiliac Joint Steroid InjectionStandard of Care - Steroid injection into the sacroiliac joint | Drug | SI Joint Steroid Injections Group |
Primary outcome
Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection.
Time frame: 6 months
The efficacy responder rate is defined as the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Numeric Rating Scale (NRS) for Pain, from Baseline to the 6-Month Visit. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
6 secondary outcomes
Quality of life improvement from baseline to each follow-up visit.
Time frame: 6 months
Clinical improvement based on pain from baseline to each follow-up visit.
Time frame: 6 months
Clinical improvement of low back pain from baseline to each follow-up visit.
Time frame: 6 months
Clinical improvement in balance and risk for falls from baseline to each follow-up visit.
Time frame: 6 months
Clinical improvement from baseline to each follow-up visit.
Time frame: 6 months
Clinical improvement based on use of medications from baseline to each follow-up visit.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Enrollment difficulties due to changes in control arm conventions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Sacroiliac Joint Somatic Dysfunction
RecruitingObservational study
Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction
Sacroiliac Joint Somatic Dysfunction, Low Back Pain
Active, not recruiting
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain
Sacroiliac Joint Somatic Dysfunction
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.
Michael Fishman, MD principal investigator
Center for Interventional Pain & Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CornerLoc SI Joint Stabilization Procedure and Intra-articular Sacroiliac Joint Steroid Injection in people with Sacroiliac Joint Somatic Dysfunction, run by CornerLoc 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 9 inclusion and 14 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 15 Jun 2023. 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?
The study was stopped early (reason given: Enrollment difficulties due to changes in control arm conventions). Results are not available in the source record.
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?
Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection. (time frame: 6 months). 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 15 Jun 2023.