Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

NCT05426356 | Terminated DMC FDA Device

• 1 other identifier: 300900
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures

Conditions

Fracture;Pelvis; Sacral Fracture; Sacroiliac; Fusion; Fragility Fracture; Insufficiency Fractures; Osteoporosis

Keywords

Elderly; Fragility fracture; Pelvic fracture fixation; SI Joint Fusion; Non-surgical management

Outcome Measures

Primary Outcomes (2)

• Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).

  The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over.

  1 year

• Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).

  If randomized to surgery: Proportion of subjects with either: * Serious adverse event deemed probably or definitely related to iFuse-TORQ * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment If randomized to NSM: Proportion of subjects with: * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment

  1 year

Secondary Outcomes (4)

• Continuous Summary Physical Performance Score (CSPPS)

  1 year

• Patient-Reported Outcomes Measurement Information System (PROMIS) physical function

  6 weeks

• Oswestry Disability Index

  6 weeks

• Numeric Rating Scale pain score

  6 weeks

Study Arms (2)

Non-Surgical Treatment

ACTIVE COMPARATOR

Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)

Other: Non-Surgical Management

Surgical Treatment

EXPERIMENTAL

Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint

Device: Surgical Intervention

Interventions

Surgical Intervention DEVICE

Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

Surgical Treatment

Non-Surgical Management OTHER

Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.

Non-Surgical Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years of age at screening.
• Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
• Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
• Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
• Prior to fracture, patient was able to ambulate using a cane or unassisted
• Medically stable to undergo either surgical or non-surgical treatment of index fracture.
• Patient is willing and able to provide written informed consent
• Patient is mentally able to comply with study protocol requirements

You may not qualify if:

• Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
• Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
• Sacral fracture potentially or definitely related to tumor
• Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
• History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
• Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
• Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
• Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
• Known allergy to titanium or titanium alloys
• Current local or systemic infection that raises the risk of surgery.
• Known or suspected active drug or alcohol abuse, including opioids.
• Patient lives or plans to move more than 100 miles from the site during the course of the study.
• Current enrollment in another investigational clinical trial related to fractures or osteoporosis

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (7)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Bryan Health Medical Center

Lincoln, Nebraska, 68501, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Orthopedic Associates of Reading

Wyomissing, Pennsylvania, 19610, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Kadlec Clinic Northwest Orthopedic & Sports Medicine

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Hip Fractures; Fractures, Stress; Osteoporosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robyn Capobianco, PhD

  SI-BONE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomized to sacral fracture fixation and SI joint fusion using iFuse-TORQ vs. non-surgical management (NSM). There is a crossover component for subjects who fail NSM.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: September 18, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)