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Sacroiliac Joint UnstableNCT06065644

Inducible Displacements of the Sacroiliac Joint Measured With CTMA

A study testing CTMA in people with Sacroiliac Joint Unstable, run by University of Bergen at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the influence of different surgical treatment options for kyphoscoliosis we measure the movement of the SI joint with Radiostereometric analysis (RSA) after lumbar fixation with CT motion analysis (CTMA). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Sacroiliac Joint Unstable
What is being tested?
CTMA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNorway
Study dates
1 Jan 2024to 1 Aug 2024
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Long fixations of 3 or more segments down to S1, (also including not correction surgery patients).
  • One segment fixations in the level of L4/5 regardless of olisthesis.

Who cannot join

  • Medical conditions that affect the SI joint (Sacroileitis, Ankylosing spondylitis, psoriasis, autoimmune illness)
  • Do not want to participate and not able to answer PROMs

Trial locations and contacts

1 site in 1 country.

Vinjar Brenna Hansen, MD contact

41468587

vinjarh@yahoo.no

Stephan M. Röhrl, PhD contact

94424677

s.m.rohrl@medisin.uio.no

Norway1 site

  • Ullevål University Hospital

    Oslo, 0450

Other trials in Norway

About this study

To evaluate the influence of different surgical treatment options for kyphoscoliosis we measure the movement of the SI joint with Radiostereometric analysis (RSA) after lumbar fixation with CT motion analysis (CTMA).

Read the detailed description

CTMA is a high precision in vivo measuring method for motion. We intend to measure sacroiliac joint (SIJ) movement in long fixations compared to short fixations. The Center for Implant and Radiostereometric Research Oslo (CIRRO) has extensive experience with RSA and established state of the art measuring method of movement in the SIJ. We have compared the methode with CTMA and established a methode for CTMA measurements at CIRRO. We will measure the movement in the SIJ in patients that have long fixations of 3 or more segments down to S1 and compare it to one segment fixation in the level of L4/5. Null hypothesis

  • The SI movement will not increase because of long fixation down to sacrum, the SIJ will not work as an adjacent level and not compensatory increase the movement.
  • The increased movement will not result in low back pain and /or pseudo radicular pain to the lower limbs CTMA is a high accuracy measuring method comparable to RSA. With a precision of RSA of 1 degree for rotation we need 10 patients in each group to detect a difference of 2 degrees for power of 90% on an alpha = 99% confidence level. Taking drop-outs into account we need a group size of 15 resulting in 30 patients (Two- sided T-test).
Being tested
CTMA
Keywords
CT method, low dose CT, Sacroiliac joint, CT-RSA, CTMA, IMA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTMADevice

    Induced displacement of the Sacroiliac joint

Study groups in NCT06065644
Study groupRoleWhat they receive
Long fixationExperimentalCT in a neutral and then by provocation (anterior straight leg raise and figure-of-four).
Receives: Device: CTMA
One segment fixationActive comparatorCT in a neutral and then by provocation (anterior straight leg raise and figure-of-four).
Receives: Device: CTMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement

    Compare the induced movement of the SIJ joint Movement measured in millimeter around x, y, z axis 3 dimensional and usually in the range of -2-2 millimeters when comparing neutral position to provoked position.

    Measured: 12 months

Secondary outcomes (4)

  1. Oswestry disability index

    From the Norwegian quality register for spinal surgery. 0-20% minimal disability, 21-40% moderate disability, 41-60% sever disability, 61-80% crippled, 81-100% bed bound

    Measured: 12 months

  2. EQ 5D 5L

    From the Norwegian quality register for spinal surgery. EQ-5D health states; When a person completes the EQ-5D questionnaire, the descriptive system produces a 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions. A numerical value can be attached to each EQ-5D health state to reflect how good or bad a health state is according to the preferences of the general population of a country/region. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).

    Measured: 12 months

  3. NRS Numeric rating scale back pain and pain to the lower limbs

    From the Norwegian quality register for spinal surgery. 0-10 pain scale for backpain and pain in the lower limbs. 0 represent no pain and 10 the worst pain ever.

    Measured: 12 months

  4. Satisfaction og treatment and result on a 7 point likert scale

    From the Norwegian quality register for spinal surgery.

    1. Complete recovered
    2. A lot better
    3. A bit better
    4. No change
    5. A bit worse
    6. A lot worse
    7. Worse than ever

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
15 patients with long fixation and 15 with fixation of L4/5.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06065644
Sponsor's protocol ID
IDSCT
Status last verified
Sep 2023
First submitted
3 Nov 2022
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Axelsson P, Karlsson BS. Intervertebral mobility in the progressive degenerative process. A radiostereometric analysis. Eur Spine J. 2004 Oct;13(6):567-72. doi: 10.1007/s00586-004-0713-5. Epub 2004 May 19.

    PubMed 15150701

  • Fayyazi AH, Ordway NR, Park SA, Fredrickson BE, Yonemura K, Yuan HA. Radiostereometric analysis of postoperative motion after application of dynesys dynamic posterior stabilization system for treatment of degenerative spondylolisthesis. J Spinal Disord Tech. 2010 Jun;23(4):236-41. doi: 10.1097/BSD.0b013e3181a4bb0b.

    PubMed 20072031

  • Nabhan A, Al-Yhary A, Ishak B, Steudel WI, Kollmar O, Steimer O. Analysis of spinal kinematics following implantation of lumbar spine disc prostheses versus fusion: radiological study. J Long Term Eff Med Implants. 2007;17(3):207-16. doi: 10.1615/jlongtermeffmedimplants.v17.i3.40.

    PubMed 19023945

  • Sturesson B, Uden A, Vleeming A. A radiostereometric analysis of the movements of the sacroiliac joints in the reciprocal straddle position. Spine (Phila Pa 1976). 2000 Jan 15;25(2):214-7. doi: 10.1097/00007632-200001150-00012.

    PubMed 10685486

  • Sturesson B, Uden A, Vleeming A. A radiostereometric analysis of movements of the sacroiliac joints during the standing hip flexion test. Spine (Phila Pa 1976). 2000 Feb 1;25(3):364-8. doi: 10.1097/00007632-200002010-00018.

    PubMed 10703111

  • Zoega B, Karrholm J, Lind B. Plate fixation adds stability to two-level anterior fusion in the cervical spine: a randomized study using radiostereometry. Eur Spine J. 1998;7(4):302-7. doi: 10.1007/s005860050079.

    PubMed 9765038

  • Broden C, Olivecrona H, Maguire GQ Jr, Noz ME, Zeleznik MP, Skoldenberg O. Accuracy and Precision of Three-Dimensional Low Dose CT Compared to Standard RSA in Acetabular Cups: An Experimental Study. Biomed Res Int. 2016;2016:5909741. doi: 10.1155/2016/5909741. Epub 2016 Jul 10.

    PubMed 27478832

  • Broden C, Sandberg O, Skoldenberg O, Stigbrand H, Hanni M, Giles JW, Emery R, Lazarinis S, Nystrom A, Olivecrona H. Low-dose CT-based implant motion analysis is a precise tool for early migration measurements of hip cups: a clinical study of 24 patients. Acta Orthop. 2020 Jun;91(3):260-265. doi: 10.1080/17453674.2020.1725345. Epub 2020 Feb 14.

    PubMed 32056507

  • Nagamoto Y, Iwasaki M, Sakaura H, Sugiura T, Fujimori T, Matsuo Y, Kashii M, Murase T, Yoshikawa H, Sugamoto K. Sacroiliac joint motion in patients with degenerative lumbar spine disorders. J Neurosurg Spine. 2015 Aug;23(2):209-16. doi: 10.3171/2014.12.SPINE14590. Epub 2015 May 15.

    PubMed 25978076

  • Forsth P, Svedmark P, Noz ME, Maguire GQ Jr, Zeleznik MP, Sanden B. Motion Analysis in Lumbar Spinal Stenosis With Degenerative Spondylolisthesis: A Feasibility Study of the 3DCT Technique Comparing Laminectomy Versus Bilateral Laminotomy. Clin Spine Surg. 2018 Oct;31(8):E397-E402. doi: 10.1097/BSD.0000000000000677.

    PubMed 29939843

  • Svedmark P, Berg S, Noz ME, Maguire GQ Jr, Zeleznik MP, Weidenhielm L, Nemeth G, Olivecrona H. A New CT Method for Assessing 3D Movements in Lumbar Facet Joints and Vertebrae in Patients before and after TDR. Biomed Res Int. 2015;2015:260703. doi: 10.1155/2015/260703. Epub 2015 Oct 26.

    PubMed 26587533

  • Svedmark P, Tullberg T, Noz ME, Maguire GQ Jr, Zeleznik MP, Weidenhielm L, Nemeth G, Olivecrona H. Three-dimensional movements of the lumbar spine facet joints and segmental movements: in vivo examinations of normal subjects with a new non-invasive method. Eur Spine J. 2012 Apr;21(4):599-605. doi: 10.1007/s00586-011-1988-y. Epub 2011 Sep 1.

    PubMed 21881866

  • Eriksson T, Maguire GQ Jr, Noz ME, Zeleznik MP, Olivecrona H, Shalabi A, Hanni M. Are low-dose CT scans a satisfactory substitute for stereoradiographs for migration studies? A preclinical test of low-dose CT scanning protocols and their application in a pilot patient. Acta Radiol. 2019 Dec;60(12):1643-1652. doi: 10.1177/0284185119844166. Epub 2019 May 1. No abstract available.

    PubMed 31042065

  • Kibsgard TJ, Rohrl SM, Roise O, Sturesson B, Stuge B. Movement of the sacroiliac joint during the Active Straight Leg Raise test in patients with long-lasting severe sacroiliac joint pain. Clin Biomech (Bristol). 2017 Aug;47:40-45. doi: 10.1016/j.clinbiomech.2017.05.014. Epub 2017 May 29.

    PubMed 28582642

  • Kibsgard TJ, Roise O, Stuge B, Rohrl SM. Precision and accuracy measurement of radiostereometric analysis applied to movement of the sacroiliac joint. Clin Orthop Relat Res. 2012 Nov;470(11):3187-94. doi: 10.1007/s11999-012-2413-5. Epub 2012 Jun 14.

    PubMed 22695864

Questions about this trial

What is this clinical trial studying?

A study testing CTMA in people with Sacroiliac Joint Unstable, run by University of Bergen at 1 site in Norway.

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 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: status not confirmed, as of the sponsor's last update on 4 Oct 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 Norway. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vinjar Brenna Hansen, MD (41468587, vinjarh@yahoo.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06065644, which also lists 15 linked publications.

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 4 Oct 2023.

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