Geriatric Pelvic Ring FracturesLoadsolNCT07608107
In-Shoe Loadsol Force Analysis Study LC1 Fractures
An observational study of Geriatric Pelvic Ring Fractures, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Pelvic Ring Fractures
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Admitted to hospital with closed, low energy pelvic ring injury.
Who may be able to join
- 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.
Who cannot join
- Dementia Immobility (wheelchair use or greater) prior to pelvic ring injury Concomitant fractures of upper or lower extremities Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19103
Derek Donegan, MD, 215-662-3340, derek.donegan@pennmedicine.upenn.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Pelvic Ring Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start18 Apr 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Pelvic Ring FracturesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608107
- Sponsor's protocol ID
- 25-1857 (859609)
- Acronym
- Loadsol
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Surgical Fixation of Geriatric Pelvic Ring Fractures Improve Gait Metrics? A In-shoe Force Analysis Study
- ClinicalTrials.gov ID
- NCT07608107
- Acronym / sponsor ID
- Loadsol / 25-1857 (859609)
- Conditions
- Geriatric Pelvic Ring Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Fixation | – | –geriatric pelvic ring fracture treated by surgical fixation |
| Non-Surgical Treatment | – | –geriatric pelvic ring fracture treated by conservative non-surgical measures. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Admitted to hospital with closed, low energy pelvic ring injury.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Dementia Immobility (wheelchair use or greater) prior to pelvic ring injury Concomitant fractures of upper or lower extremities Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait Analysis
Time frame: 2 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Pelvic Ring Fractures, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mounika Ponakala, MS (7327071037, mounika.ponakala@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.