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Asymptomatic: Had Total Joint Replacement (Arthroplasty) for Pain

N/A
Waitlist Available
Led By Sandip Biswal, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (6 months post-op), 12 months post-op, 18 months post-op
Awards & highlights

Study Summary

The purpose of this research is to determine if a PET/MRI scan using FDG can accurately identify the source of chronic pain. Identifying the source of pain may help doctors treat chronic pain more effectively. Approximately 128 participants will be enrolled and can expect to be on study for up to 12 months.

Eligible Conditions
  • Pain
  • Nociceptive Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (6 months post-op), 12 months post-op, 18 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (6 months post-op), 12 months post-op, 18 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in SUVmax (chronic pain)
Location of Pain Compared to Target-to-Background (TTB) or SUVmax
SUVmax (chronic pain vs healthy)
Secondary outcome measures
Change in Pain Scores (chronic pain)
Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups)
Radiology Review Scores
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Open Surgical Procedure (Arthroplasty)Experimental Treatment3 Interventions
PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement). 6 month post-op scans 12 month post-op scans 18 month post-op scans
Group II: Less Invasive Procedure (Arthroscopy)Experimental Treatment3 Interventions
PPSP subjects who have undergone hip (or knee) arthroscopy (i.e., less invasive joint surgical procedure involving scopes and lower profile surgical tools) - 6 month post-op scans
Group III: Asymptomatic: Less Invasive Procedure (Arthroscopy)Experimental Treatment3 Interventions
Asymptomatic subjects who have undergone hip or knee arthroscopy. - single scan during one study visit (up to 3.5 hours)
Group IV: Asymptomatic: Had Total Joint Replacement (Arthroplasty)Experimental Treatment3 Interventions
Asymptomatic subjects who have undergone total hip or total knee arthroplasty. - single scan during one study visit (up to 3.5 hours)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT imaging
2021
Completed Phase 3
~430
PET/MRI
2013
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,812 Total Patients Enrolled
4 Trials studying Pain
462 Patients Enrolled for Pain
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,259 Total Patients Enrolled
16 Trials studying Pain
10,055 Patients Enrolled for Pain
Sandip Biswal, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
4 Previous Clinical Trials
402 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
FDG PET/MR Imaging of Peripheral Pain Generators
2024. "FDG PET/MR Imaging of Peripheral Pain Generators". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171659.
All > Madison
~85 spots leftby Oct 2026
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