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Surgery

Timing of Surgery and Rehab for Knee Injuries

N/A
Recruiting
Led By James Irrgang, PT, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female military personnel and civilians between the ages of 16 and 55 with a MLKI (defined as a complete grade III injury of two or more ligaments)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly starting at 6 months post-randomization and continuing to 24 months
Awards & highlights

Study Summary

This trial is investigating the effects of timing of surgery and post-operative rehabilitation on patients with multiple ligament knee injuries. The hypothesis is that early surgery and early rehabilitation will lead to a more complete return to pre-injury activities and better physical function.

Who is the study for?
This trial is for military personnel and civilians aged 16-55 who have a severe knee injury involving two or more ligaments but no fractures that prevent weight-bearing, previous knee surgeries, conditions affecting post-op care adherence, nerve injuries in the knee area, or traumatic brain injuries.Check my eligibility
What is being tested?
The STaR Trial investigates the outcomes of early versus delayed surgery and rehabilitation on recovery from multiple ligament knee injuries. Participants will be randomly assigned to receive either early or delayed interventions with the goal of improving return to duty, work, sports, and physical function.See study design
What are the potential side effects?
Potential side effects are not explicitly listed for this trial; however, general risks may include pain at the surgery site, infection risk from surgical intervention, complications from anesthesia during surgery and challenges related to delayed healing or rehab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 16 and 55 years old and have a severe knee injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly starting at 6 months post-randomization and continuing to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly starting at 6 months post-randomization and continuing to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported Physical Function - Activity Limitation Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire
Time to Return to Pre-Injury Level of Activity
Secondary outcome measures
Emotional Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire
Global Rating of Change (GRC)
International Knee Documentation Committee Subjective Knee Form (IKDC-SKF)
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Early Surgery & Early RehabExperimental Treatment2 Interventions
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and early rehabilitation.
Group II: Early Surgery & Delayed RehabExperimental Treatment2 Interventions
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and delayed rehabilitation.
Group III: Early Rehab OnlyExperimental Treatment1 Intervention
Individuals not eligible for randomization to timing of surgery will be randomized to only early rehabilitation.
Group IV: Delayed Surgery & Early RehabExperimental Treatment2 Interventions
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and early rehabilitation.
Group V: Delayed Surgery & Delayed RehabExperimental Treatment2 Interventions
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and delayed rehabilitation.
Group VI: Delayed Rehab OnlyExperimental Treatment1 Intervention
Individuals not eligible for randomization to timing of surgery will be randomized to only delayed rehabilitation.

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER
1,379 Previous Clinical Trials
1,587,806 Total Patients Enrolled
Louisiana State University Health Sciences Center ShreveportOTHER
45 Previous Clinical Trials
16,529 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
868,464 Total Patients Enrolled

Media Library

Delayed Surgery (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT03543098 — N/A
Multiple Ligament Knee Injury Research Study Groups: Early Surgery & Early Rehab, Early Surgery & Delayed Rehab, Delayed Surgery & Early Rehab, Delayed Surgery & Delayed Rehab, Early Rehab Only, Delayed Rehab Only
Multiple Ligament Knee Injury Clinical Trial 2023: Delayed Surgery Highlights & Side Effects. Trial Name: NCT03543098 — N/A
Delayed Surgery (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03543098 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is participation in this clinical investigation accessible?

"This medical trial is recruiting 690 patients with knee dislocations between the ages of 16-55. The primary criteria for selection are: any impediment that could prevent conformance to postoperative instructions; ripped or dislodged quadriceps/patellar tendons; fractures close to an articulating joint which may stop weightbearing after surgery; staged surgical treatment as required, external fixator use over 10 days, inability to bear weight on non-injured leg and any procedure that prevents early bearing of load or range of motion. Male and female personnel from both military and civilian backgrounds will be eligible if they meet these conditions and"

Answered by AI

Is there any availability left in this clinical trial for participants?

"Affirmative. Clinical trials portal clinicaltrials.gov provides information that this research is currently recruiting participants. It was originally posted on July 31st 2018 and has had a recent update on September 21st 2022. The study requires 690 volunteers from one location to take part in the trial."

Answered by AI

What is the desired outcome of this clinical experiment?

"This trial, which will span a period of 24 months following randomization is designed to measure the Time to Return to Pre-Injury Level of Activity. Secondary objectives include analyzing Emotional Impairment Scale scores on the Multiple Ligament Quality of Life (MLQoL) Questionnaire and Global Rating of Change values as well as eliciting Patient Acceptable Symptom State responses from patients."

Answered by AI

Is this research program recruiting individuals of advanced age?

"Eligibility for this trial requires that patients are aged between 16 and 55."

Answered by AI

What is the maximum number of participants accepted for this research endeavor?

"Indeed, clinicaltrials.gov holds evidence of this medical trial actively seeking participants since its inaugural post on July 31st 2018. The last update was made September 21st 2022 and the study requires 690 individuals to sign up at a single site."

Answered by AI
~38 spots leftby Sep 2024