Recruiting

Operative vs. Non-Operative

Sponsor:

More Foundation

Code:

NCT04044300

Conditions

Sacral Fracture

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Single screw fixation

Conservative

Study Details

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.

Conditions

Sacral Fracture

Study ID

NCT04044300

Start date

Aug, 2019

Status verified date

Aug, 2019

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Operative

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

experimental: Non-operative

Continued pain management and physical therapy

Interventions

Single screw fixation

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

Conservative

Continued pain management and physical therapy.

Primary outcome measure

  • Timed Up and Go (TUG) Test [ Time Frame: 2 weeks ]
  • Sacral Region Pain [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

The CORE Institute

Recruiting

Phoenix, Arizona, United States, 85023

Contacts

More Information

Sponsor

More Foundation

Last update posted

Aug 5, 2019

Last verified

Aug, 2019

Keywords

  • sacral fracture, function, pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by More Foundation on 2019-08-05.