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.
- Multiple Ligament Knee Injury
- Knee Dislocation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Monthly starting at 6 months post-randomization and continuing to 24 months
Trial Safety
Safety Progress
Trial Design
6 Treatment Groups
Early Surgery & Delayed Rehab
1 of 6
Early Surgery & Early Rehab
1 of 6
Delayed Surgery & Delayed Rehab
1 of 6
Early Rehab Only
1 of 6
Delayed Rehab Only
1 of 6
Delayed Surgery & Early Rehab
1 of 6
Experimental Treatment
690 Total Participants · 6 Treatment Groups
Primary Treatment: Early Surgery & Delayed Rehab · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 16 - 55 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Schenck, Robert C.. 2021. “CORR Insights®: Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/corr.0000000000001785.
- Schenck RC Jr. CORR Insights(R): Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial. Clin Orthop Relat Res. 2021 Aug 1;479(8):1737-1739. doi: 10.1097/CORR.0000000000001785. No abstract available.
- James J. Irrgang 2018. "STaR Trial: Multiple Ligament Knee Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03543098.
Frequently Asked Questions
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
Is this research program recruiting individuals of advanced age?
"Eligibility for this trial requires that patients are aged between 16 and 55." - Anonymous Online Contributor
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." - Anonymous Online Contributor