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Knee injury recovery: when is the best time for surgery and rehab?

NCT ID NCT03543098

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 690 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

16 to 55 years

Sex

Anyone

Healthy volunteers

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

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.

Knee Dislocation Knee Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States