Motion Analysis in Sacroiliac Joint Dysfunction

NCT04824534 | Completed

• 1 other identifier: Z2020223
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The sacroiliac joint (SIJ) is increasingly being recognized as a potential cause of chronic low back and buttock pain. The SIJ is affected in 14-22% in patients presenting with this pain. Conservative treatment options include oral analgesic use, physical therapy, radiofrequency denervation and intraarticular steroid injections. When non-surgical treatment remains ineffective, surgical intervention is a reasonable option in the form of minimally invasive sacroiliac joint fusion (MISJF). Recent literature suggests that imbalance and sagittal sacropelvic morphology can occur in patients with SIJ dysfunction. Using motion analyses, the investigators want to evaluate full movement patterns in SIJ patients. Potentially, changes in these parameters can be observed before and after MISJF surgery. Objective: To determine spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity in patients suffering from SIJ dysfunction before and after MISJF surgery. Movement parameters will also be determined in healthy individuals to compare with patients suffering from SIJ dysfunction. Methods: This prospective cohort study will include patients enlisted for MISJF surgery because of SIJ dysfunction. Spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity will be examined before and 3 months after surgery in a professional Motion Lab. Movement parameter of healthy individuals will also be evaluated at the Motion Lab. All data will be analyzed using MATLAB software.

Conditions

Sacroiliac Joint Dysfunction

Keywords

Movement analysis

Outcome Measures

Primary Outcomes (13)

• Change in pelvic obliquity during one leg stance will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in pelvic tilt during one leg stance will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in pelvic obliquity during sit-to-stand task will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in pelvic tilt during sit-to-stand task will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in cadence during gait will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in stride length during gait will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in step width during gait will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in percentage of swing phase during gait will be collected using VICON Nexus systems.

  percentage of total gait

  Before and 3 months after surgery

• Change in percentage of single support phase during gait will be collected using VICON Nexus systems.

  percentage of total gait

  Before and 3 months after surgery

• Change in percentage of double support phase during gait will be collected using VICON Nexus systems.

  percentage of total gait

  Before and 3 months after surgery

• Change in center of gravity during gait will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in center of gravity during one leg stance will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

• Change in center of gravity during sit-to-stand tasks will be collected using VICON Nexus systems.

  measured in mm in 3 different axis

  Before and 3 months after surgery

Secondary Outcomes (3)

• Change in Visual Analgogue Scale pain score (0 to 10)

  before and 3 months after surgery

• Change in disability measured using the Oswestry Disability Index (ODI)

  before and 3 months after surgery

• Change in quality-adjusted life years (QALY) measured with EQ-5D-5L

  before and 3 months after surgery

Study Arms (3)

Healthy subjects

Other: Motion analysis

Healthy subjects matching baseline characteristics with patients

Other: Motion analysis

Patients with sarociliac joint dysfunction

Other: Motion analysis

Interventions

Motion analysis OTHER

Motion analysis is performed in the Motionlab using Vicon systems. Surgery (in case of SI patients) is performed with iFuse implant system for sacroiliac joint fusion

Healthy subjects; Healthy subjects matching baseline characteristics with patients; Patients with sarociliac joint dysfunction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Sacroiliac joint dysfunction mostly effects women.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In total 10 patients suffering from SIJ dysfunction with an indication for MISJF, 10 healthy individuals under the age of 25 and 10 healthy individuals matching the demographic characteristics of patients suffering from SI dysfunction will be included. This is a total of 30 individuals.

You may qualify if:

• \- Healthy individuals under the age of 25, with no history of SI dysfunction or lower back related illnesses
• \- Healthy individuals between the age of 25 and 45, female sex and postpartum with no history of SI dysfunction or lower back related illnesses
• The patient is suffering from SIJ dysfunction (uni- or bilateral) because of postpartum pelvic instability or because of Ehlers Danlos syndrome and is enlisted for primary MISJF surgery.
• The patient is mobile enough to perform several tests at the motion lab, needed to obtain spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity.

You may not qualify if:

• The individual is not mobile and/or unable to perform tests at the motion lab, needed to obtain spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity.
• Inadequate command of the Dutch language.
• Age under 18 years.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Zuyd University of Applied Sciences: collaborator

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6419 PC, Netherlands

Location

Study Officials

• Inez Curfs, MD, PhD

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Orthopedic surgery

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: April 1, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 30, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

NL (1)