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STaR Trial: Multiple Ligament Knee Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543098
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Rhode Island Hospital
Hospital for Special Surgery, New York
Mayo Clinic
New York University
University of Cincinnati
University of Connecticut
University of Kentucky
University of Maryland, College Park
University of Michigan
University of Minnesota
University of Missouri-Columbia
University of New Mexico
The University of Texas Health Science Center, Houston
University of Virginia
University of Washington
Washington University School of Medicine
San Antonio Military Medical Center
Walter Reed National Military Medical Center
William Beaumont Army Medical Center
TRIA Orthopaedic Center
Wake Forest University
Nova Scotia Health Authority
St. Michael's Hospital, Toronto
University of Western Ontario, Canada
Information provided by (Responsible Party):
James J. Irrgang, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Knee Dislocations Multiple Ligament Knee Injuries Procedure: Early Surgery Procedure: Delayed Surgery Procedure: Early Rehab Procedure: Delayed Rehab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: STaR (Surgical Timing and Rehabilitation) Trial for Multiple Ligament Knee Injuries
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and early rehabilitation.
Procedure: Early Surgery
Subjects will undergo surgery within 6 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.

Experimental: Early Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and delayed rehabilitation.
Procedure: Early Surgery
Subjects will undergo surgery within 6 weeks after injury.

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.

Experimental: Delayed Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and early rehabilitation.
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.

Experimental: Delayed Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and delayed rehabilitation.
Procedure: Delayed Surgery
Subjects will undergo surgery 12 to 16 weeks after injury.

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.

Experimental: Early Rehab Only
Individuals not eligible for randomization to timing of surgery will be randomized to only early rehabilitation.
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.

Experimental: Delayed Rehab Only
Individuals not eligible for randomization to timing of surgery will be randomized to only delayed rehabilitation.
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.




Primary Outcome Measures :
  1. Time to Return to Pre-Injury Level of Activity [ Time Frame: Monthly starting at 6 months post-randomization and continuing to 24 months ]
    Time to return to pre-injury level military duty, work and/ sports

  2. Patient-Reported Physical Function - Activity Limitation Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire [ Time Frame: 24 months following randomization ]
    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.


Secondary Outcome Measures :
  1. Physical Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire. [ Time Frame: 24 months following randomization ]
    Physical Impairment Scale measures the physical symptoms experienced by an individual with a multiple ligament knee injury. The Physical Impairment Scale score ranges from 0 to 100 with a score of 0 representing no physical symptoms due to the multiple ligament knee injury.

  2. Emotional Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire [ Time Frame: 24 months following randomization ]
    Emotional Impairment Scale measures the changes in mood and emotions experienced by an individual with a multiple ligament knee injury. The Emotional Impairment Scale score ranges from 0 to 100 with a score of 0 representing no changes in mood and emotions due to the multiple ligament knee injury.

  3. Social Involvement Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire [ Time Frame: 24 months following randomization ]
    Social Involvement Scale measures the social limitations experienced by an individual with a multiple ligament knee injury. The Social Involvement Scale score ranges from 0 to 100 with a score of 0 representing no social limitations due to the multiple ligament knee injury.

  4. International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) [ Time Frame: 24 months following randomization ]
    The International Knee Documentation Committee Subjective Knee Form is an 18-item knee-specific patient-reported measure of symptoms, function and sports activities for individuals with a variety of knee conditions, including MLKIs. The International Knee Documentation Committee Subjective Knee Form score ranges from 0 to 100 with higher scores indicating the absence of symptoms and higher levels of function and sports activity.

  5. Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Scale [ Time Frame: 24 months following randomization ]
    Patient Reported Outcome Measurement Information System Physical Function Scale consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.

  6. Patient Reported Outcome Measurement Information System (PROMIS) Global 1- Global 10 [ Time Frame: 24 months following randomization ]
    The Patient Reported Outcome Measurement Information System (PROMIS) Global 10 is a 10-item patient-reported measure of physical and emotional health. The items are combined into two scores, one representing global physical function, the other representing global mental function. The Physical and Emotional Function scores are scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.

  7. Patient Acceptable Symptom State (PASS) [ Time Frame: 24 months following randomization ]
    The Patient Acceptable Symptom State is a single question that measures an individual's satisfaction with the state of their knee health. The Patient Acceptable Symptom State question is answered Yes or No. A response of Yes indicates that the individual is satisfied with his/her current symptom state.

  8. Global Rating of Change (GRC) [ Time Frame: 24 months following randomization ]
    The Global Rating of Change asks the individual to compare his/her current functional status to his/her functional status at the time of enrollment/post-injury. The responses for the Global Rating of Change range from +7 (greatly better) to -7 (greatly worse). Higher scores representing greater improvement in function since the time of enrollment/post-injury.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543098


Contacts
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Contact: James Irrgang, PT,PhD (412) 383-9865 jirrgang@pitt.edu
Contact: Volker Musahl, MD 412-432-3618 musahlv@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: James Irrgang, PT, PhD    412-383-9865    jirrgang@pitt.edu   
Contact: Volker Musahl, MD    (412) 432-3662    musahlv@upmc.edu   
Principal Investigator: James J Irrgang, PT, PhD         
Principal Investigator: Volker Musahl, MD         
Sub-Investigator: Andrew D Lynch, PT, PhD         
Sub-Investigator: Charity G Patterson, PhD         
Sub-Investigator: Alexandra Gil, PT, PhD         
Sub-Investigator: Bryson Lesniak, MD         
Sub-Investigator: Peter Siska, MD         
Sub-Investigator: Ivan Tarkin, MD         
Sponsors and Collaborators
University of Pittsburgh
Rhode Island Hospital
Hospital for Special Surgery, New York
Mayo Clinic
New York University
University of Cincinnati
University of Connecticut
University of Kentucky
University of Maryland, College Park
University of Michigan
University of Minnesota
University of Missouri-Columbia
University of New Mexico
The University of Texas Health Science Center, Houston
University of Virginia
University of Washington
Washington University School of Medicine
San Antonio Military Medical Center
Walter Reed National Military Medical Center
William Beaumont Army Medical Center
TRIA Orthopaedic Center
Wake Forest University
Nova Scotia Health Authority
St. Michael's Hospital, Toronto
University of Western Ontario, Canada
Investigators
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Principal Investigator: James Irrgang, PT, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by James J. Irrgang, University of Pittsburgh:
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Responsible Party: James J. Irrgang, Professor and Chair, Department of Physical Therapy, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03543098    
Other Study ID Numbers: PRO16090503
W81XWH-17-2-0073 ( Other Grant/Funding Number: United States Department of Defense )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A public-use version of the dataset will be constructed by the DCC with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported by CRF in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or SAS datasets. Documentation will be in .pdf files.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James J. Irrgang, University of Pittsburgh:
Knee Injury
Knee Injuries
Knee Surgery
Rehabilitation
Knee Dislocation
Multiple Ligament Knee Injury
Additional relevant MeSH terms:
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Joint Dislocations
Knee Dislocation
Wounds and Injuries
Knee Injuries
Joint Diseases
Musculoskeletal Diseases
Leg Injuries