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Clinical Trials/NCT04824534
NCT04824534CompletedNot Applicable

Motion Analysis Before and After Surgical Sacroiliac Joint Fusion in Patients With Sacroiliac Joint Dysfunction

Zuyderland Medisch Centrum1 site in 1 country30 target enrollmentStarted: March 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Change in pelvic obliquity during one leg stance will be collected using VICON Nexus systems.

Study Overview

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.

Detailed Description

1.2 RATIONALE The sacroiliac joint (SIJ) is an anatomic structure that 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.1,2 A wide variability exists in the clinical presentation of SIJ dysfunction, from localized pain around the SIJ to radiating pain into the groin or even the entire lower extremity.3 This sometimes makes it challenging to accurately diagnose SIJ dysfunction during physical examination. Most surgeons palpate the SIJ to determine the level and area of tenderness. There are also several provocative tests, but their reliability is limited.4,5 Currently, diagnostic SIJ intraarticular injection is the benchmark for diagnosing SIJ dysfunction.6 Conservative treatment options include oral analgesic use, physical therapy, radiofrequency denervation and intraarticular steroid injections. 7-11 When non-surgical treatment remains ineffective, minimally invasive sacroiliac joint fusion (MISJF) is a reasonable option.12 Current literature suggests that imbalance and sagittal sacropelvic morphology can occur in patients with SIJ dysfunction.13 Sagittal imbalance and sagittal sacropelvic morphology can in turn lead to compensatory motion in the SIJ, leading to more dysfunction and pain.14 The investigators wonder if changes in spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity can be observed in patients suffering from SIJ dysfunction before and after MISJF surgery with the help of motion analysis. Expectedly, these changes correlate to the clinical condition patients are in

1.3 OBJECTIVES.

This study consists of two different parts, each with different objectives:

  1. Process evaluation on measuring movement patterns in the motion lab:

a. What differences can be detected in spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity between healthy individuals and patients suffering from SI dysfunction? 2. Clinical evaluation of MISJF surgery in patients with SI dysfunction:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

percentage of total gait

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

Time Frame: Before and 3 months after surgery

percentage of total gait

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

measured in mm in 3 different axis

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

Time Frame: Before and 3 months after surgery

percentage of total gait

Secondary Outcomes

  • 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)

Investigators

Sponsor
Zuyderland Medisch Centrum
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sem Hermans

Researcher Orthopedic surgery

Zuyderland Medisch Centrum

Study Sites (1)

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