Inducible Displacements of the Sacroiliac Joint Measured With CTMA

September 28, 2023 updated by: University of Bergen
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, 0450
        • Ullevål University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long fixation
CT in a neutral and then by provocation (anterior straight leg raise and figure-of-four).
Device: CTMA
Induced displacement of the Sacroiliac joint
Active Comparator: One segment fixation
CT in a neutral and then by provocation (anterior straight leg raise and figure-of-four).
Device: CTMA
Induced displacement of the Sacroiliac joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: 12 months
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
12 months
EQ 5D 5L
Time Frame: 12 months
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).
12 months
NRS Numeric rating scale back pain and pain to the lower limbs
Time Frame: 12 months
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.
12 months
Satisfaction og treatment and result on a 7 point likert scale
Time Frame: 12 months

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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Oslo University Hospital

Investigators

  • Study Director: Stephan M. Röhrl, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IDSCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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