Movement of the Sacroiliac (SI) Joint, Comparing Conventional RSA With the Sectra Implant Movement Analysis.

NCT04752007 | Completed

• 1 other identifier: IMSRA
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Movement of the Sacroiliac (SI) Joint, comparing conventional RSA with the Sectra Implant Movement analysis using a low dose CT for high accuracy measurement. A feasibility study for a future kohort study.

Conditions

Sacroiliac Instability

Outcome Measures

Primary Outcomes (1)

• Movement of the SI joint in mikrometer

  Movement analysis

  4 weeks

Study Arms (2)

RSA group

ACTIVE COMPARATOR

Conventional RSA to measure the movement in th SI joint.

Radiation: ASLR; RSA; SI joint movement: stright leg raise with 1 kg load; Radiation: Fig.Four; RSA; SI joint movement: One side figure of four position with 1 kg load; Radiation: Supine; RSA; SI joint movement: supine position

CT group

ACTIVE COMPARATOR

Low dose CT to measure the movement in th SI joint.

Radiation: ASLR; CT; SI joint movement: stright leg raise with 1 kg load; Radiation: Fig.Four; CT; SI joint movement: One side figure of four position with 1 kg load; Radiation: Supine; CT; SI joint movement: supine position

Interventions

ASLR; CT; SI joint movement: stright leg raise with 1 kg load RADIATION

Measurement of the SI joint movement in mikrometer

CT group

Fig.Four; CT; SI joint movement: One side figure of four position with 1 kg load RADIATION

Measurement of the SI joint movement in mikrometer

CT group

Supine; CT; SI joint movement: supine position RADIATION

Baseline position

CT group

ASLR; RSA; SI joint movement: stright leg raise with 1 kg load RADIATION

Measurement of the SI joint movement in mikrometer

RSA group

Fig.Four; RSA; SI joint movement: One side figure of four position with 1 kg load RADIATION

Measurement of the SI joint movement in mikrometer

RSA group

Supine; RSA; SI joint movement: supine position RADIATION

Baseline position

RSA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies, approximately five years ago, conducted at Ullevål University Hospital.

You may not qualify if:

• The patients that can not perfome the provocation images of the SI joints.
• Pregnancy
• Not able to or do not want to participate

Sponsors & Collaborators

• University of Bergen: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Cirro at Ullevål Uiversity Hospital

Oslo, Norway

Location

Related Publications (15)

• 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.

  PMID: 15150701 BACKGROUND

• 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.

  PMID: 20072031 BACKGROUND

• 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.

  PMID: 19023945 BACKGROUND

• 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.

  PMID: 10685486 BACKGROUND

• 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.

  PMID: 10703111 BACKGROUND

• 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.

  PMID: 9765038 BACKGROUND

• 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.

  PMID: 27478832 BACKGROUND

• 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.

  PMID: 32056507 BACKGROUND

• 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.

  PMID: 25978076 BACKGROUND

• 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.

  PMID: 29939843 BACKGROUND

• 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.

  PMID: 26587533 BACKGROUND

• 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.

  PMID: 21881866 BACKGROUND

• 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.

  PMID: 31042065 BACKGROUND

• 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.

  PMID: 28582642 BACKGROUND

• 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.

  PMID: 22695864 BACKGROUND

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephan M Rohrl, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will be measured using conventional RSA and the other using low dose CT.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: February 12, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)