Motion Analysis Before and After Surgical Sacroiliac Joint Fusion in Patients With Sacroiliac Joint Dysfunction
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:
- 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
Sem Hermans
Researcher Orthopedic surgery
Zuyderland Medisch Centrum
