An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA

NCT03809520 | Completed Results FDA Device

• 1 other identifier: 201612747
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.

Conditions

Post-traumatic Osteoarthritis; Orthopedic Disorder; Trauma; Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up

  Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging at the final follow-up visit using contralateral, uninjured side as control. Final follow-up occurred at 18 month follow-up or at 5 years follow-up.

  Final imaging assessed at 18 months or up to 5 years post-injury

Secondary Outcomes (2)

• Change in Ankle Pain

  final follow-up occurred at either 18 months or up to 5 years post-injury

• Change in Ankle Function

  18 months or up to 5 years post-injury

Study Arms (1)

Experimental: pedCAT

EXPERIMENTAL

Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury. Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury

Radiation: pedCAT

Interventions

pedCAT RADIATION

Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.

Experimental: pedCAT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury

You may not qualify if:

• Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70

Sponsors & Collaborators

• J L Marsh: lead
• Orthopaedic Trauma Association: collaborator
• Arthritis Foundation: collaborator
• University of Washington: collaborator
• University of Utah: collaborator
• University of Kansas Medical Center: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Wounds and Injuries; Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Ankle Injuries; Leg Injuries

Results Point of Contact

• Title: Dr. J. Lawrence Marsh
• Organization: University of Iowa, Department of Orthopedics & Rehabilitation

natalie-glass@uiowa.edu

3193849046

Study Officials

• J L Marsh, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 18, 2019
• Study Start: February 1, 2017
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)