Clinical trial NCT04044300: Operative vs Non-Operative Treatment of Sacral Fractures
Official title: A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacral Fracture
Keywords: sacral fracture, function, pain
Lead sponsor: More Foundation
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2019-08-05
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 to one of two treatment arms
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients ≥ 60 years of age
2. Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI
3. Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event
4. Onset of symptoms within four weeks of presentation to hospital
5. Significant pain or disability determined by:

   1. Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed "Up \& Go" (TUG) test, or
   2. Inability to complete the TUG test
   3. Inability to get out of bed secondary to pain for 2 consecutive days

Exclusion Criteria:

1. Vertically or rotationally unstable pelvic ring injuries
2. Pathologic fracture secondary to tumor
3. Non-ambulatory prior to injury
4. Acute neurologic deficit
5. High-energy mechanism of injury
6. Concomitant lower extremity fractures affecting ambulation
7. Presence of another injury or medical condition that prevents ambulation
8. Presence of hardware or sacral morphology that prevents percutaneous sacral fixation
9. Enrollment in another research study that precludes co-enrollment
10. Inability to speak English
11. Dementia with inability to answer questions and participate in study
12. 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.)
13. Incarcerated or pending incarceration

Primary outcomes:
measure: Timed Up and Go (TUG) Test
timeFrame: 2 weeks
measure: Sacral Region Pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Discharge Disposition Location
timeFrame: Up to 21 days
measure: Facility Length of Stay
timeFrame: Up to 21 days
measure: Ambulatory aid
timeFrame: 2 weeks
measure: Complications
timeFrame: Up to 1 year
measure: Patient Reported Health Outcome
timeFrame: Change from baseline to 1 year
measure: Patient Reported Outcome
timeFrame: Change from baseline to 1 year
Other outcomes:
measure: Hospital length of stay
timeFrame: Up to 21 days
measure: Narcotic use
timeFrame: 2 weeks
measure: Healing
timeFrame: Change in healing from baseline to 1 year
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
Study officials:
affiliation: The CORE Institute
name: Clifford B Jones, MD
role: PRINCIPAL_INVESTIGATOR
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