Back to resultsGeriatric Lateral Compression 1 Pelvic Fractures
Primary Purpose
Lateral Compression 1 Pelvic Fracture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous transiliac - transsacral screw fixation
Pain management and physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Compression 1 Pelvic Fracture focused on measuring Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis
Eligibility Criteria
Inclusion Criteria: Patients >/= 60 years of age Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI Low energy mechanism of injury or an insufficiency fracture without a precipitating event Acute injury within four weeks of presentation Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up & Go" (TUG) assessment, or inability to complete the TUG assessment. Exclusion Criteria: Dementia Vertically or rotationally unstable pelvic ring injuries Pathologic fracture secondary to tumor Non-ambulatory prior to injury Acute neurologic deficit High-energy mechanism of injury Concomitant injuries affecting ambulation Presence of another injury or medical condition that prevents ambulation Presence of implant or sacral morphology that prevents percutaneous sacral fixation Enrollment in another research study the precludes co-enrollment Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.) Incarcerated or pending incarceration
Sites / Locations
- Allina Health
- HealthPartners, Regions HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Operative
Non-operative
Arm Description
Percutaneous transiliac-transsacral screw fixation
Pain management and physical therapy advanced with weight bearing as tolerated.
Outcomes
Primary Outcome Measures
Timed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down.
Secondary Outcome Measures
Sacral Region Pain by Visual Analog Scale
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Timed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down.
Discharge Disposition Location
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Longest Distance of Ambulation
How far a patient was able to walk
Use of Narcotic Pain Medication
Use of narcotic pain medication, total in milligram equivalents (MME)
Hospital Length of Stay
Number of days admitted to hospital during treatment
Rate of Complications
Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality
Full Information
NCT ID
NCT05765669
First Posted
February 22, 2023
Last Updated
May 25, 2023
Sponsor
HealthPartners Institute
Collaborators
Orthopaedic Trauma Association, Allina Health System
1. Study Identification
Unique Protocol Identification Number
NCT05765669
Brief Title
Geriatric Lateral Compression 1 Pelvic Fractures
Official Title
Percutaneous Sacral Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
Orthopaedic Trauma Association, Allina Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous transiliac - transsacral screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.
Detailed Description
This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous transiliac-transsacral screw fixation, or a nonoperative group, defined as treatment with therapies and pain management only.
Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Compression 1 Pelvic Fracture
Keywords
Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operative
Arm Type
Experimental
Arm Description
Percutaneous transiliac-transsacral screw fixation
Arm Title
Non-operative
Arm Type
Experimental
Arm Description
Pain management and physical therapy advanced with weight bearing as tolerated.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous transiliac - transsacral screw fixation
Intervention Description
Surgical intervention in the form of percutaneous transiliac - transsacral screw fixation
Intervention Type
Other
Intervention Name(s)
Pain management and physical therapy
Intervention Description
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG) assessment
Description
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down.
Time Frame
Day 2 after treatment
Secondary Outcome Measure Information:
Title
Sacral Region Pain by Visual Analog Scale
Description
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Time Frame
Day 2, 2 weeks, 6 weeks, and 3 months after treatment
Title
Timed Up and Go (TUG) assessment
Description
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down.
Time Frame
2 weeks, 6 weeks, and 3 months after treatment
Title
Discharge Disposition Location
Description
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Time Frame
Post discharge from treatment, an average of 5 days from being admitted to the hospital
Title
Longest Distance of Ambulation
Description
How far a patient was able to walk
Time Frame
Day 2 after treatment
Title
Use of Narcotic Pain Medication
Description
Use of narcotic pain medication, total in milligram equivalents (MME)
Time Frame
Day 2 after treatment
Title
Hospital Length of Stay
Description
Number of days admitted to hospital during treatment
Time Frame
Post discharge from treatment, an average of 5 days from being admitted to the hospital
Title
Rate of Complications
Description
Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality
Time Frame
2 weeks, 6 weeks, and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients >/= 60 years of age
Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
Low energy mechanism of injury or an insufficiency fracture without a precipitating event
Acute injury within four weeks of presentation
Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up & Go" (TUG) assessment, or inability to complete the TUG assessment.
Exclusion Criteria:
Dementia
Vertically or rotationally unstable pelvic ring injuries
Pathologic fracture secondary to tumor
Non-ambulatory prior to injury
Acute neurologic deficit
High-energy mechanism of injury
Concomitant injuries affecting ambulation
Presence of another injury or medical condition that prevents ambulation
Presence of implant or sacral morphology that prevents percutaneous sacral fixation
Enrollment in another research study the precludes co-enrollment
Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
Incarcerated or pending incarceration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai P Nguyen, MD
Phone
651-254-3669
Email
mai.p.nguyen@healthpartners.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Vang, BA
Phone
651-254-6961
Email
sandy.x.vang@healthpartners.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai P. Nguyen, MD
Organizational Affiliation
University of Minnesota and HealthPartners
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allina Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennadiy A Busel, MD
Phone
651-254-1513
Email
gennadiy.busel@allina.com
Facility Name
HealthPartners, Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai P Nguyen, MD
Phone
651-254-3669
Email
mai.p.nguyen@healthpartners.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.orthoguidelines.org/guidelines
Description
American Academy of Orthopaedic Surgeon clinical practice guidelines
Learn more about this trial
Geriatric Lateral Compression 1 Pelvic Fractures
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