Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT03543098

STaR Trial: Multiple Ligament Knee Injuries

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate effects of timing of surgery (early vs. delayed) and timing of post-operative rehabilitation (early vs. delayed) for the treatment of military personnel and civilians that sustain a multiple ligament knee injury. To achieve this overall objective of this project, we will conduct two parallel randomized clinical trials. For the first study we will randomize individuals to timing of surgery and timing of post-operative rehabilitation. We hypothesize that early surgery, early rehabilitation and the combination of early surgery with early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports and better patient-reported physical function. In the second study, those whose timing of surgery can not be randomized, will be only randomized to early or delayed rehabilitation. For this study, we hypothesize that early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports activity and better patient-reported physical function.

Official title: STaR (Surgical Timing and Rehabilitation) Trial for Multiple Ligament Knee Injuries

Key Details

Gender

All

Age Range

16 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

690

Start Date

2018-07-31

Completion Date

2027-06

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Knee Dislocations Multiple Ligament Knee Injuries

Interventions

PROCEDURE

Early Surgery

Subjects will undergo surgery within 6 weeks after injury.

PROCEDURE

Delayed Surgery

Subjects will undergo surgery 12 to 16 weeks after injury.

PROCEDURE

Early Rehab

Subjects will undergo rehabilitation that will include unrestricted range of motion exercises and use of a weightbearing as tolerated gait starting after the first post-operative visit with the surgeon.

PROCEDURE

Delayed Rehab

Subjects will undergo rehabilitation that will include use of a knee brace locked in extension, no range of motion exercises and use of non-weightbearing gait for the first 4 weeks after surgery.

For the clinical trials for both aims, 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) will be eligible to participate. Individuals with a nerve injury or biceps or popliteus tendon rupture or avulsion will not be excluded from participation in either trial. Individuals will be excluded from both trials if they: 1. Prior knee ligament surgery of the involved knee; 2. Torn or avulsed patellar or quadriceps tendon; 3. Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery; 4. Require use of an external fixator for greater than 10 days; 5. Planned staged surgical treatment; 6. Unable to weight bear on the contralateral uninjured leg; 7. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care; 8. Surgical procedures that precludes early weight-bearing or range of motion. 9. Any condition that would preclude the ability to comply with post-operative guidelines. Additional Eligibility Criteria for Participation in Aim 1 - Randomization to Both Timing of Surgery and Post-Operative Rehabilitation To be eligible to participate in the study for Aim 1 individuals with a MLKI must present to orthopaedic surgery in time to undergo definitive surgery within 6 weeks of injury if randomized to the early surgery group. Individuals will also be ineligible to participate in the study for Aim 1 if they have: 1. Vascular injury that dictates timing of surgery; 2. Poly trauma that precludes surgery within 6 weeks of injury; 3. Skin or soft tissue injury that precludes early surgery and rehabilitation. Additional Eligibility Criteria for Participation in Aim 2 - Randomization to Only timing of Post-operative Rehabilitation Subjects with a MLKI that present to orthopaedic surgery at a time that precludes randomization to early surgery or have an injury that precludes randomizing the timing of surgery (such as a vascular injury) as well as those that refuse randomization to the timing of surgery will be eligible to participate in the study for Aim 2 which randomizes subjects to only early vs. delayed rehabilitation. Individuals will also be excluded from the trial that randomizes only the timing post-operative rehabilitation if they have: 1. Vascular surgery that precludes early rehabilitation; 2. Polytrauma that limits ability to participate in post-operative care; 3. Skin or soft tissue injury that precludes early rehabilitation

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States