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Trial record 89 of 976 for:    scale | Norway

Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (SIFSO)

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ClinicalTrials.gov Identifier: NCT03507049
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Thomas Johan Kibsgård, Oslo University Hospital

Brief Summary:
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Somatic Dysfunction Procedure: iFuse Procedure: sham group Radiation: fMRI study Not Applicable

Detailed Description:

Sacroiliac(SI) joint pain can lead to long-lasting severe pain and reduce physical function. It is shown to be the source of pain in 13-30% of patients with low back pain. Former surgical techniques had a high level of complications and low success rates. Newer mini-invasive surgical approaches have shown promising results in scientific studies. It is difficult to find an adequate control group for surgery as most patients already have tried conservative and alternative treatments without effect. A sham-designed study is the best alternative. This study is designed as a prospective randomized double blinded controlled mulitcenter trial. The investigators want to examine whether there is a difference in SI joint pain in patients operated with miniinvasive arthrodesis of the SI joint compared to a sham operated control group. Patients with SI joint pain are included. They will be randomized to either surgery with arthrodesis or sham surgery. Neither patient nor health personell who work with the patient after the surgery will know what has been done. The primary end point for the study is sacroiliac joint pain on the operated side after 6 months.

The Swedish research center did not get ethical approval for proper sham, but have ethical approval for a pseudo sham procedure. All the Swedish patients will receive local anesthetic to the skin incision site prior to randomization. If randomized to sham the Swedish patients will remain prone and will be sedated but still self-breathing. They are therefore not under general anesthesia and are not intubated. The skin incision will be made and sown back up and the sham patients are then awoken. Swedish patients randomized to arthrodesis will receive general anesthesia.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : April 25, 2023

Arm Intervention/treatment
Active Comparator: Intervention group
The intervention Group receives operation with SI-joint arthrodesis with the iFuse implant. The patient undergoes full anesthesia. The procedure starts with an approximately 5cm long skin incision over the posterolateral aspect of the pelvis. A guide-pin is inserted over the sacroiliac joint at the desired entry-point, verified by fluoroscopy. The surgeons drills and boraches over the pin and the ifuse implant is inserted. This is repeated for a total of three implants. The wound is closed with non-resorbable suture. An injection of the SIJ with Marcaine is performed under guidance of fluoroscopy after closure.
Procedure: iFuse
ifuse will be implanted as described in section on the active comparator arm of the study.
Other Name: SI Bone iFuse

Sham Comparator: Sham group

The sham operation will consist of the surgeon making the same skin incision as for an iFuse procedure, although nothing more, and then closing the wound.

The patients undergoing a sham operation will be under general anesthesia for a random time of 20-40minutes in order to keep the two procedures as similar as possible.

An injection of the SIJ with Marcain is performed under guidance of fluorscopy after closure.

Procedure: sham group
sham surgery will be performed as desrcribed in section on sham comparator.
Other Name: Sham surgery

Functional MRI study
The Swedish patients will also undergo quantitative sensory testing at inclusion and at 6 month follow-up. At the same time they will undergo a cerebral MRI and a Functional MRI looking at activation of the CNS from pain in the sacroiliac joints induced by one leg lift. The purpose of this study is to look at contributing factors in treatment response. One hopes to map which CNS mechanisms are involved in causing the chronic pain these patients experience as well as how they respond to treatment.
Radiation: fMRI study
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.

Sham Comparator: Pesudo sham arm
The Swedish sham patients will not undergo general anesthesia. They will receive local anesthetics (ropivacain) at the incision site. They will remain prone and sedated, but still self-breathing. The surgeon will do a skin incision and then close it up. they will be sedated for no longer than 10minutes.
Procedure: sham group
sham surgery will be performed as desrcribed in section on sham comparator.
Other Name: Sham surgery




Primary Outcome Measures :
  1. Primary outcome measure - Numeric Rating Scale operated side [ Time Frame: 6 months ]
    the primary endpoint is change in Numeric Rating Scale(NRS) pain-score on the operated side at six months postoperatively. Numeric rating scale is a pain-score scale from 0-10, where 0 is no pain and 10 is worst possible pain.


Secondary Outcome Measures :
  1. Baseline NRS [ Time Frame: baseline, 3, 6, 12 and 24 months ]
    Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months

  2. Global NRS [ Time Frame: baseline,3 ,6 ,12 ,24 months ]
    Change from baseline global NRS at 3,6,12 and 24 months

  3. NRS on non-operated side [ Time Frame: baseline, 3, 6, 12, 24 months ]
    Change from baseline in non-operated side NRS at 3,6,12 and 24 months

  4. NRS leg pain [ Time Frame: baseline, 3,6,12,24 months ]
    Change from baseline leg pain NRS at 3,6,12,24 months

  5. Oswestry disability index (ODI) [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in disability due to pelvic pain measured by Oswestry Disability Index(ODI) at 3,6,12,24 months

  6. Pelvic girdle questionnaire [ Time Frame: baseline, 3, 6, 12, 24 months ]
    Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 3,6,12,24 months

  7. Quality of life (EQ-5D) [ Time Frame: baseline, 3, 6, 12, 24 months ]
    Change in quality of life measured by EQ-5D at 3,6,12,24 months

  8. Device breakage, loosening or migration on CT of the sacroiliac joint [ Time Frame: 12 months ]
    Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint.


Other Outcome Measures:
  1. Adverse events [ Time Frame: 3,6,12,24 months ]
    registration of any adverse events after procedure completed

  2. Change in Compression test of the sacroiliac joint [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in compression test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint.

  3. Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in Posterior Pelvic pain Provocation (P4) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint.

  4. Change in Palpation of long dorsal ligament as test of the sacroiliac joint [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in Palpation of long dorsal ligament as test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not along the ligament.

  5. Change in Patricks (FABER) test of the sacroiliac joint [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in Patricks (FABER) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint. .

  6. Change in active straight leg raise test (ASLR) of the sacroiliac joint [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in active straight leg raise test(ASLR) of the sacroiliac joint which is an objective clinical test. Results are recorded on a grad 0 to 5, where not difficult at all = 0; minimally difficult = 1; somewhat difficult = 2; fairly difficult = 3; very difficult = 4; unable to do = 5.

  7. Change in Gaenslens test [ Time Frame: baseline, 3, 6,12, 24 months ]
    Change in Gaenslens test which is an objective clinical tests for the sacroiliac joint. Outcome is recorded as positive or negative test dependent on whether pain is provoked or not in the sacroiliac joint.

  8. 6 minute walk test to record ambulatory status [ Time Frame: baseline, 3, 6,12, 24 months. ]
    Patients will be tested with 6minute walk test to test ambulatory status. The test is performed by marking a distance equal to 50meters. The patient is instructed to walk back and forth between the marks as quickly and as many times as they manage in 6 minutes. The total distance walked is recorded.

  9. Timed up and og test to record ambulatory status [ Time Frame: baseline, 3, 6,12, 24 months. ]
    Patients will be tested with Timed up and go, to test ambulatory status.Timed up and go test the time it takes the patient to get up from a Chair, walk 3 meters and back and be seated again.

  10. Work status [ Time Frame: baseline, 3, 6,12, 24 months. ]
    Patients will be asked to fill out standardized questionnaire on work status



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21-70 at time of screening
  2. Patient with suspected SIJ pain for >6 months or >18 months for pregnancy induced pelvic girdle pain.
  3. Diagnosis of the SI joint as the primary pain generator based on ALL of the following:

A. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test)

B. Patient has at least 3 of 6 physical examination maneuvers specific for SI joint pain:

  1. Compression
  2. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)
  3. Palpation of the long dorsal ligament
  4. Patrick's test (Faber)
  5. Leg Raise (ASLR )
  6. Geanslens test

C. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint (including previous documented test <6 months ago)

4. Baseline Oswestry Disability Index (ODI) score of at least 30%

5. Baseline lower back pain score of at least 5 on 0-10 point NRS

6. Patient should have tried adequate forms of conservative treatment with little or no response.

7. Patient has signed study-specific informed consent

8. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

9. Patients with unilateral or bilateral pain can be included in the study if they clearly can differentiate between the two sides. It is the most painful side that will be included and randomized to SIJ fusion or sham surgery in the study.

Exclusion Criteria:

  1. Severe low back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture.
  2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
  3. History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
  4. Spine surgery during the past 12 months.
  5. Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)
  6. Documented osteomalacia or other metabolic bone disease
  7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
  8. Patients with prior successful fusion to the contra lateral side are exluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507049


Contacts
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Contact: Engelke Marie Dr Randers, Cand med +4793829395 engelker@gmail.com; maeran@ous-hf.no
Contact: Thomas Johan Dr Kibsgard, Dr Med PhD +4799030831 uxkibt@ous-hf.no

Locations
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Norway
Rikshospitalet, Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Engelke dr Randers, Cand med    93829395 ext +47    engelker@gmail.com; maeran@ous-hf.no   
Contact: Thomas Johan Dr Kibsgard, Dr Med PhD       uxkibt@ous-hf.no   
Sweden
Karolinska University Hospital Active, not recruiting
Stockholm, Sweden
Sponsors and Collaborators
Oslo University Hospital
Karolinska University Hospital
Investigators
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Principal Investigator: Thomas Johan Dr Kibsgård, PhD, MD Oslo University Hospital

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Responsible Party: Thomas Johan Kibsgård, Senior consultant, associated professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03507049     History of Changes
Other Study ID Numbers: 2017/1892 A
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthralgia
Ankylosis
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms