Knee injury recovery: when is the best time for surgery and rehab?
NCT ID NCT03543098
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether having surgery earlier (within 6 weeks) or later (12-16 weeks) after a severe knee injury leads to better recovery. It also compares starting rehab early versus later after surgery. The trial includes 690 military personnel and civilians aged 16-55 with multiple ligament knee injuries. The goal is to find the best timing to help people return to their normal activities faster and with less pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this trial could show the best timing for surgery and rehab to help people with severe knee injuries return to work, sports, or military duty faster and with better function.
- What could go wrong
- This is a comparative effectiveness study, not testing a new drug or cure. Results may not apply to all patients, and individual recovery can vary widely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 690 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States