Operative vs Non-Operative Treatment of Sacral Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.

Detailed Description
-----------------
Sacral fragility fractures cause significant pain and morbidity in the elderly population in which they occur. These low-energy pelvic injuries can cause prolonged immobility, long hospital stays, and requirement for higher levels of care. Subjects will undergo a 48 hour period of physical therapy and pain management following identification of the sacral fracture.. If the subject has substantial pain or disability, the subject is eligible for enrollment in the RCT and randomization of 1:1 to one of two groups. Group 1: Operative treatment: A single trans iliac trans sacral screw will be inserted at the sacral one or sacral two level based upon fracture location. Group 2: Conservative (non-operative) treatment: Continued pain management and physical therapy advanced with weight bearing as tolerated. The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients. Primary Objective: To compare the functional outcome and pain in elderly patients surgically treated compared to those non-operatively treated for sacral fractures. Secondary Objective: To compare discharge disposition, length of stay in care facility post-discharge, complications, and need for ambulatory aid in elderly patients surgically treated compared to those non-operatively treated for sacral fractures. Hypothesis: Subjects in the operative group will have improvement in functional outcome and pain at 2 weeks, higher likelihood of discharge to independent living, shorter stays in care facilities post-discharge, less complications, and less need for ambulatory aids.

Official Title
-----------------
A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures

Conditions
-----------------
Sacral Fracture

Intervention / Treatment
-----------------
* Procedure: Single screw fixation
* Other: Conservative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥ 60 years of age Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event Onset of symptoms within four weeks of presentation to hospital Significant pain or disability determined by: Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed Up & Go (TUG) test, or Inability to complete the TUG test Inability to get out of bed secondary to pain for 2 consecutive days Exclusion Criteria: 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 lower extremity fractures affecting ambulation Presence of another injury or medical condition that prevents ambulation Presence of hardware or sacral morphology that prevents percutaneous sacral fixation Enrollment in another research study that precludes co-enrollment Inability to speak English Dementia with inability to answer questions and participate in study Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.) Incarcerated or pending incarceration

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 to one of two treatment arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative<br>A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level. | Procedure: Single screw fixation<br>* A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.<br>|
| Experimental: Non-operative<br>Continued pain management and physical therapy | Procedure: Single screw fixation<br>* A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.<br>Other: Conservative<br>* Continued pain management and physical therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) Test | TUG Test | 2 weeks | 
| Sacral Region Pain | Visual Analog Pain Scale, minimum score 0, maximum score 10, from no pain to worst possible pain | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge Disposition Location | Location that subject was discharged to at hospital discharge: Home, Rehabilitation, Skilled Nursing Facility | Up to 21 days | 
| Facility Length of Stay | Number of days in a rehabilitation or skilled nursing facility after hospital discharge | Up to 21 days | 
| Ambulatory aid | Use of walker, cane, or wheelchair | 2 weeks | 
| Complications | Screw migration, secondary surgery related to primary procedure, neurological deficit related to screw insertion, surgical site infection, wound dehiscence, deep infection, related re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, death | Up to 1 year | 
| Patient Reported Health Outcome | Veterans Rand 12-item Health Survey (VR-12). This is a health related quality of life survey with 2 scores, Physical Component Score (PCS) including general health, physical functioning, physical role accomplishment, bodily pain and Mental Component Score (MCS) including role-emotional, vitality/mental health, social functioning. The results of the VR-12 are reported as 2 scores, MCS and PCS. The score range is 0-100 for each score, where a 0 score indicates the lowest level of health and a score of 100 indicates the highest level of health. The US population average PCS and MCS are both 50 points. The standard deviation is 10 points. | Change from baseline to 1 year | 
| Patient Reported Outcome | Hip dysfunction and Osteoarthritis Outcome Score (HOOS), Total score of 0-100 with higher scores representing better function | Change from baseline to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sacral fracture, function, pain