In-Shoe Loadsol Force Analysis Study LC1 Fractures (Loadsol)

Does Surgical Fixation of Geriatric Pelvic Ring Fractures Improve Gait Metrics? A In-shoe Force Analysis Study

To determine if surgical fixation of geriatric pelvic ring fractures improves objective gait metrics compared to non-operative management, and to correlate gait parameters with clinical outcomes including hospital quality measures.

Study Overview

• Status: Recruiting
• Conditions: Geriatric Pelvic Ring Fractures

Detailed Description

This is a prospective, single-center cohort study. The study is non-randomized and non-blinded. Patients will be assigned to operative or non-operative treatment groups based on standard clinical decision-making by the treating orthopedic surgeon, not by randomization. The study utilizes the Loadsol Gait Analysis device to collect objective gait metrics at multiple time points. This is an observational study design where treatment allocation follows standard of care protocols.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mounika Ponakala, MS; Phone Number: 7327071037; Email: mounika.ponakala@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • Penn Presbyterian Medical Center
      • Contact: Derek Donegan, MD; Phone Number: 215-662-3340; Email: derek.donegan@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Admitted to hospital with closed, low energy pelvic ring injury.

Description

Inclusion Criteria:

Closed, low energy pelvic ring injury Inability to discharge home from emergency room due to pain and limited weight bearing No neurovascular compromise No severe medical comorbidities preventing treatment.

Exclusion Criteria:

Dementia Immobility (wheelchair use or greater) prior to pelvic ring injury Concomitant fractures of upper or lower extremities Inability to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Surgical Fixation; geriatric pelvic ring fracture treated by surgical fixation
Non-Surgical Treatment; geriatric pelvic ring fracture treated by conservative non-surgical measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Analysis	Use of gait analysis to compare average peak force of lower limb ipsilateral to posterior pelvic ring injury, compared between pre-operative and post-operative gait trials	2 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-1857 (859609)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No