Trial Outcomes & Findings for An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA (NCT NCT03809520)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

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

Results posted on

2026-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: pedCAT 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Overall Study STARTED	97
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: pedCAT 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Overall Study Withdrawal by Subject	15
Overall Study Lost to Follow-up	10

Baseline Characteristics

data not collected on all subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: pedCAT n=97 Participants 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Age, Continuous	45.3 years STANDARD_DEVIATION 15.2 • n=97 Participants
Sex: Female, Male Female	28 Participants n=84 Participants • data not collected on all subjects
Sex: Female, Male Male	56 Participants n=84 Participants • data not collected on all subjects
Region of Enrollment United States	97 participants n=97 Participants

PRIMARY outcome

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

Population: joint space width, minimum value

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.

Outcome measures

Outcome measures
Measure	Experimental: pedCAT n=70 Participants 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up	0.912 mm Standard Deviation 0.492

SECONDARY outcome

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

Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaire at final follow-up visit. The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference instrument was utilized. Scores are reported as T-scores from a representative group of US adults. The mean for the US population is 50 and the standard deviation is 10. HIgher PROMIS T-scores indicate a greater amount of the health domain being measured. In this case, a higher T-score of PROMIS Pain Interference indicates greater pain.

Outcome measures

Outcome measures
Measure	Experimental: pedCAT n=39 Participants 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Change in Ankle Pain	57.2 T-score Standard Deviation 8.7

SECONDARY outcome

Timeframe: 18 months or up to 5 years post-injury

Subjective measure of foot and ankle function measured using the Foot and Ankle Ability Measure (FAAM) questionnaire. Scores range from 0-100%. higher is better. Scores were initially collected at 6 month visit Final scores collected at 18 month visit or up to 5 years post-injury

Outcome measures

Outcome measures
Measure	Experimental: pedCAT n=52 Participants 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 pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Change in Ankle Function	12.9 score on a scale Standard Deviation 20.3

Adverse Events

Experimental: pedCAT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. J. Lawrence Marsh

University of Iowa, Department of Orthopedics & Rehabilitation

Phone: 3193849046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place