Joint DysfunctionNCT01861899
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
An observational study of Joint Dysfunction, run by Globus Medical Inc at 1 site in United States.
Trial summary
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Joint Dysfunction
- What is being tested?
- SI-LOK
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2013to 11 Apr 2019
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be screened according to inclusion/exclusion criteria and will be selected for the treatment using the SI-LOK® system
Who may be able to join
- A maximum age of 70 years
- Diagnosis of SIJ dysfunction
- Ability to provide Informed Consent for study participation and to return for all follow-up visits
Who cannot join
- Previous documentation of osteopenia or osteomalacia
- History of metabolic bone disease (e.g. diabetes requiring daily insulin)
- Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- History of substance abuse (drugs or alcohol)
- Condition that would preclude completing patient self assessment questionnaires
- Mentally incompetent or prisoner
- Currently a participant in another study
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Center
Saint Albans, Vermont, 05478
About this study
Official title: Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction.
The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
Read the detailed description
Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.
Forms completed by patients will be checked, initialed and dated by the site coordinator.
Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P < 0.05 significance level.
- Conditions
- Joint Dysfunction
- Being tested
- SI-LOK
- Keywords
- Sacro-iliac Joint
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-LOKDevice
Sacro-iliac joint fusion
| Study group | Role | What they receive |
|---|---|---|
| SI-Joint Dysfunction | Device- SI-LOK Receives: Device: SI-LOK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Evaluation
Fusion Assessment Radiolucency
Measured: 2 years
Secondary outcomes (1)
Hospitalization Data
Operative Time Blood Loss Blood Transfusion Hospitalization Time
Measured: Intra-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start2 May 2013
- Primary completion5 Jul 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Barnum, MD, Principal investigator, Northwestern Medical Center, St Albans, VT 05478
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861899
- Sponsor's protocol ID
- RGC12-004_PL_C
- Status last verified
- Sep 2020
- First submitted
- 21 May 2013
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
- ClinicalTrials.gov ID
- NCT01861899
- Acronym / sponsor ID
- RGC12-004_PL_C
- Conditions
- Joint Dysfunction
- Keywords
- Sacro-iliac Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 2 May 2013 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 24 May 2013 (estimated)
- 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.
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction.
The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
Detailed description
Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.
Forms completed by patients will be checked, initialed and dated by the site coordinator.
Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P < 0.05 significance level.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SI-Joint Dysfunction | – | Device: SI-LOKDevice- SI-LOK |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be screened according to inclusion/exclusion criteria and will be selected for the treatment using the SI-LOK® system
Key inclusion criteria (3 listed)
- A maximum age of 70 years
- Diagnosis of SIJ dysfunction
- Ability to provide Informed Consent for study participation and to return for all follow-up visits
Key exclusion criteria (8 listed)
- Previous documentation of osteopenia or osteomalacia
- History of metabolic bone disease (e.g. diabetes requiring daily insulin)
- Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- History of substance abuse (drugs or alcohol)
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 |
|---|---|---|
| SI-LOKSacro-iliac joint fusion | Device | SI-Joint Dysfunction |
Primary outcome
Radiographic Evaluation
Time frame: 2 years
Fusion Assessment Radiolucency
1 secondary outcome
Hospitalization Data
Time frame: Intra-Operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Joint Dysfunction
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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 Barnum, MD principal investigator
Northwestern Medical Center, St Albans, VT 05478
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 Joint Dysfunction, run by Globus Medical Inc 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Sep 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Evaluation (time frame: 2 years). 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 11 Sep 2020.