STaR Trial: Multiple Ligament Knee Injuries

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.

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.

Sponsors & Collaborators

• Rhode Island Hospital

  collaborator OTHER

• Hospital for Special Surgery, New York

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• New York University

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Missouri-Columbia

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• San Antonio Military Medical Center

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• William Beaumont Army Medical Center

  collaborator FED

• TRIA Orthopaedic Center

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Western University, Canada

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Yale University

  collaborator OTHER

• OrthoCarolina Research Institute, Inc.

  collaborator OTHER

• Louisiana State University Health Sciences Center Shreveport

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Orlando Health, Inc.

  collaborator OTHER

• Fraser Orthopaedic Institute

  collaborator UNKNOWN

• University of Pittsburgh

  lead OTHER

Principal Investigators

• James Irrgang, PT, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-31

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations