STaR Trial: Multiple Ligament Knee Injuries

NCT03543098 | Active Not Recruiting DMC

• 2 other identifiers: STUDY20110374W81XWH-17-2-0073
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knee Injury; Knee Injuries; Knee Surgery; Rehabilitation; Knee Dislocation; Multiple Ligament Knee Injury

Outcome Measures

Primary Outcomes (2)

• Time to Return to Pre-Injury Level of Activity

  Time to return to pre-injury level military duty, work and/ sports

  Monthly starting at 6 months post-randomization and continuing to 24 months

• Patient-Reported Physical Function - Activity Limitation Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire

  Activity Limitation Scale of the Multiple Ligament Quality of Life scale measures the degree of difficulty an individual with a multiple ligament knee injury experiences with simple and complex activities as related to his/her knee. The Activity Limitation Scale score ranges from 0 to 100 with a score of 0 representing no activity limitations due to the multiple ligament knee injury.

  24 months following randomization

Secondary Outcomes (8)

• Physical Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire.

  24 months following randomization

• Emotional Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire

  24 months following randomization

• Social Involvement Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire

  24 months following randomization

• International Knee Documentation Committee Subjective Knee Form (IKDC-SKF)

  24 months following randomization

• Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Scale

  24 months following randomization

Study Arms (6)

Early Surgery & Early Rehab

EXPERIMENTAL

Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and early rehabilitation.

Procedure: Early Surgery; Procedure: Early Rehab

Early Surgery & Delayed Rehab

EXPERIMENTAL

Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and delayed rehabilitation.

Procedure: Early Surgery; Procedure: Delayed Rehab

Delayed Surgery & Early Rehab

EXPERIMENTAL

Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and early rehabilitation.

Procedure: Delayed Surgery; Procedure: Early Rehab

Delayed Surgery & Delayed Rehab

EXPERIMENTAL

Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and delayed rehabilitation.

Procedure: Delayed Surgery; Procedure: Delayed Rehab

Early Rehab Only

EXPERIMENTAL

Individuals not eligible for randomization to timing of surgery will be randomized to only early rehabilitation.

Procedure: Early Rehab

Delayed Rehab Only

EXPERIMENTAL

Individuals not eligible for randomization to timing of surgery will be randomized to only delayed rehabilitation.

Procedure: Delayed Rehab

Interventions

Early Surgery PROCEDURE

Subjects will undergo surgery within 6 weeks after injury.

Early Surgery & Delayed Rehab; Early Surgery & Early Rehab

Delayed Surgery PROCEDURE

Subjects will undergo surgery 12 to 16 weeks after injury.

Delayed Surgery & Delayed Rehab; Delayed Surgery & Early Rehab

Early Rehab PROCEDURE

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.

Delayed Surgery & Early Rehab; Early Rehab Only; Early Surgery & Early Rehab

Delayed Rehab PROCEDURE

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.

Delayed Rehab Only; Delayed Surgery & Delayed Rehab; Early Surgery & Delayed Rehab

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: collaborator
• Mayo Clinic: collaborator
• New York University: collaborator
• University of Cincinnati: collaborator
• University of Kentucky: collaborator
• University of Maryland: collaborator
• University of Michigan: collaborator
• University of Minnesota: collaborator
• University of Missouri-Columbia: collaborator
• University of New Mexico: collaborator
• University of Washington: collaborator
• Washington University School of Medicine: collaborator
• San Antonio Military Medical Center: collaborator
• Walter Reed National Military Medical Center: collaborator
• William Beaumont Army Medical Center: collaborator
• TRIA Orthopaedic Center: collaborator
• Wake Forest University: collaborator
• Unity Health Toronto: collaborator
• Western University, Canada: collaborator
• Ochsner Health System: collaborator
• Yale University: collaborator
• Louisiana State University Health Sciences Center Shreveport: collaborator
• Duke University: collaborator
• University of Calgary: collaborator
• Oregon Health and Science University: collaborator
• Wake Forest University Health Sciences: collaborator
• Orlando Health, Inc.: collaborator
• Fraser Orthopaedic Institute: collaborator
• University of Pittsburgh: lead
• Rhode Island Hospital: collaborator
• OrthoCarolina Research Institute, Inc.: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 33944810 DERIVED

MeSH Terms

Conditions

Knee Dislocation; Knee Injuries

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Leg Injuries

Study Officials

• James Irrgang, PT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: These are unblinded trials as the participants will know when they are receiving surgery and when they are receiving rehabilitation. The data that are collected as part of the standard of care clinical follow-up will be recorded by the clinicians that know the participant's surgery assignment. The primary outcome and most of the secondary outcomes are patient self-report. Given that our interventions are either early or delayed surgery and/or rehabilitation, it is difficult for us to estimate the direction of potential bias (if any) that could come from the unblinded nature of this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Physical Therapy

Model Details: Two parallel prospective randomized multi-center clinical trials. Trial 1 will evaluate the effects of both the timing of surgery and post-operative rehabilitation. Trial 2 will evaluate only the effects of timing of post-operative rehabilitation.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 1, 2018
• Study Start: July 31, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The public-use version of the database will be made available 2 years after the study's main paper is published.
• Access Criteria: Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.

Locations

US (1)