Operative vs Non-Operative Treatment of Sacral Fractures

More Foundation

Status: Unknown

Conditions: Sacral Fracture

Treatments: Procedure: Single screw fixation; Other: Conservative

Study type: Interventional

Funder types: Other

Identifiers

NCT04044300

3209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Operative

Experimental group

Description:

A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level.

Treatment:

Procedure: Single screw fixation

Non-operative

Experimental group

Description:

Continued pain management and physical therapy

Treatment:

Other: Conservative

Procedure: Single screw fixation