Timing of Surgery and Rehab for Knee Injuries

Overseen By Volker Musahl, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Prior knee surgery, Fracture, TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for surgery and rehabilitation in individuals with serious knee injuries involving multiple ligaments. It compares early versus delayed surgery and rehabilitation to determine which combination helps individuals return to normal activities, such as work and sports, more quickly. Researchers will study two groups: one examining both surgery and rehabilitation timing, and the other focusing solely on rehabilitation timing. This trial includes military personnel and civilians who face challenges like being unable to participate in activities due to their injury. As an unphased trial, it provides a unique opportunity to contribute to understanding optimal recovery strategies for knee injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both early and delayed surgeries for multiple knee ligament injuries are generally safe. One study found no major differences in recovery and function between early and delayed surgeries. However, earlier surgery might improve sports activity outcomes for some individuals.

For recovery exercises, starting early tends to yield better results. Studies indicate that beginning rehab sooner can enhance stability, movement, and overall function without added risks. Delaying rehab, however, might lead to increased pain and poorer physical function.

Overall, the treatments in this trial are well-tolerated, and existing evidence supports their safety for knee injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of surgery and rehabilitation for knee injuries in a way that hasn't been thoroughly examined before. Traditional treatment often follows a set order, with surgery typically happening soon after injury and rehab following. This trial is unique because it looks at both early and delayed approaches to surgery and rehab, aiming to find out if changing the timing can improve recovery. By testing different combinations, including just early or delayed rehab without surgery, the trial could uncover more effective strategies for recovery and potentially reduce the time it takes for patients to return to normal activities.

What evidence suggests that this trial's treatments could be effective for knee injuries?

This trial will compare different timing strategies for surgery and rehabilitation after a multiligament knee injury. Research has shown that early surgery can improve movement and reduce issues like joint stiffness compared to delayed surgery. Participants may receive early surgery combined with early rehabilitation, starting physical therapy soon after surgery, which helps speed recovery and return to normal activities and sports. Alternatively, some participants may undergo delayed surgery or delayed rehabilitation. Delaying rehab can lead to increased pain and poorer physical function. Overall, early surgery and rehabilitation offer the best chance for a full and quick recovery. ^{1 3 6 7 8}

Who Is on the Research Team?

James J Irrgang, PT PhD FAPTA

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for military personnel and civilians aged 16-55 who have a severe knee injury involving two or more ligaments but no fractures that prevent weight-bearing, previous knee surgeries, conditions affecting post-op care adherence, nerve injuries in the knee area, or traumatic brain injuries.

Inclusion Criteria

I am between 16 and 55 years old and have a severe knee injury.

Exclusion Criteria

I had surgery that stops me from putting weight on or moving a body part early on.

I have a nerve injury or a torn biceps or popliteus tendon.

I cannot put weight on my uninjured leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Preoperative evaluation including collection of baseline demographics, activity level, and a physical examination

1-2 weeks

Treatment

Randomization to early or delayed surgery and early or delayed post-operative rehabilitation

6-16 weeks

Post-Operative Rehabilitation

Participants undergo early or delayed rehabilitation with specific protocols for weightbearing and range of motion exercises

6-12 weeks

Clinical Follow-Up

Standard of care clinical follow-up visits to monitor recovery and collect outcome data

9-12 months

Research Follow-Up

Participants are followed for 24 months to assess time to return to pre-injury activities and patient-reported outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Rehab
• Delayed Surgery
• Early Rehab
• Early Surgery

Trial Overview

The STaR Trial investigates the outcomes of early versus delayed surgery and rehabilitation on recovery from multiple ligament knee injuries. Participants will be randomly assigned to receive either early or delayed interventions with the goal of improving return to duty, work, sports, and physical function.

How Is the Trial Designed?

Group I: Early Surgery & Early Rehab Experimental Treatment 2 Interventions

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

Group II: Early Surgery & Delayed Rehab Experimental Treatment 2 Interventions

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

Group III: Early Rehab Only Experimental Treatment 1 Intervention

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

Group IV: Delayed Surgery & Early Rehab Experimental Treatment 2 Interventions

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

Group V: Delayed Surgery & Delayed Rehab Experimental Treatment 2 Interventions

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

Group VI: Delayed Rehab Only Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Louisiana State University Health Sciences Center Shreveport

Collaborator

Trials

52

Recruited

19,400+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Early surgical intervention for multi-ligament knee injuries leads to significantly better clinical outcomes, as indicated by higher Lysholm scores, compared to delayed surgery, based on a meta-analysis of 260 patients across eight studies.

While early surgery showed a trend towards improved total range of motion, the difference was not statistically significant, suggesting that the timing of surgery primarily impacts functional recovery rather than range of motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early or delayed reconstruction in multi-ligament knee injuries: A systematic review and meta-analysis. Hohmann, E., Glatt, V., Tetsworth, K.[2018]

In a study of 249 patients undergoing scheduled orthopedic surgeries, the median delay to surgery was 4 days, with a mean delay of 17.6 days, highlighting significant inefficiencies in surgical scheduling.

The main cause of surgical delay was identified as a lack of available operating room slots, and factors such as the urgency of the surgery and weekend admissions were significant predictors of delays exceeding 3 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic surgical treatment delays at a tertiary hospital in sub Saharan Africa: Communication gaps and implications for clinical outcomes. Ifesanya, AO., Ogundele, OJ., Ifesanya, JU.[2021]

In a study of 383 patients with open tibial fractures, there was no significant difference in infection rates between those receiving early (within 6 hours) and delayed (more than 6 hours) surgical treatment, with infection rates of 53/184 and 51/199 respectively.

The need for secondary surgical procedures to promote bone union was also similar between the two groups, indicating that timing of surgery may not impact overall outcomes in terms of infection and healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed surgical treatment of open tibial fractures: effect on the rates of infection and need of secondary surgical procedures to promote bone union. Charalambous, CP., Siddique, I., Zenios, M., et al.[2019]

In a study of 32 patients with severe knee ligament injuries, early reconstruction (within 2 weeks) resulted in 100% clinical stability and 89% pain-free status at an average follow-up of 25 months.

In contrast, knees that underwent delayed reconstruction (averaging 4.8 months post-injury) or were not surgically treated showed poor outcomes, with only 13% being clinically stable and 33% experiencing persistent pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early operative reconstruction of severe ligamentous knee injuries in patients with multiple trauma. Limbird, TJ., Garside, WB., Richards, DB.[2006]

Patients with knee injuries face significant physical and psychological challenges due to delays in receiving specialist diagnosis and surgery, as revealed through in-depth interviews with 36 participants over 6 months.

Improving communication and information provision within the healthcare system could enhance patient well-being and coping strategies during waiting periods for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to talk? Patient experiences of waiting for clinical management of knee injuries. Robling, MR., Pill, RM., Hood, K., et al.[2016]

ACL surgery performed within 3 weeks of injury is safe and leads to comparable long-term outcomes as surgery performed after a delay of more than 3 weeks, based on a study of 58 patients followed for 2 years.

Patients who underwent early ACL surgery showed faster initial improvements in clinical measurements and functional scores, despite starting with poorer outcomes, indicating that early intervention may benefit recovery timelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Surgery Performed Less Than 3 Weeks After Injury Is Not Inferior to Delayed Surgery. Chua, K., Kang, JBY., Fook-Chong, S., et al.[2021]

Patients who underwent surgery for closed distal fibular fractures within one day had no wound complications, while those treated after a delay of more than one week had a significant increase in complications (11% vs 0%; p = 0.004).

Delaying surgery not only raises the risk of infectious wound complications but also negatively impacts functional outcomes and patient satisfaction, with significant differences in scores measured after 43 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The timing of ankle fracture surgery and the effect on infectious complications; a case series and systematic review of the literature. Schepers, T., De Vries, MR., Van Lieshout, EM., et al.[2021]

In a study of 1361 adults under 50 with femoral neck fractures, 67.8% received surgery within 24 hours, indicating timely surgical intervention is common among this population.

However, factors like a high Charlson comorbidity index, pelvic fractures, and treatment at lower-level trauma centers were linked to delays in surgery, which were associated with increased rates of serious and minor adverse events, highlighting the need for improved care strategies for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Treatment of Femoral Neck Fractures After 24 Hours in Patients Between the Ages of 18 and 49 Is Associated With Poor Inpatient Outcomes: An Analysis of 1361 Patients in the National Trauma Data Bank. Samuel, AM., Russo, GS., Lukasiewicz, AM., et al.[2016]

In human trauma care, the approach to surgical intervention has evolved from delayed surgery to early definitive treatment, and now includes damage control surgery to minimize complications and improve outcomes.

In veterinary medicine, there is a lack of evidence regarding the optimal timing for surgical intervention in trauma cases, highlighting the need for more research to guide clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of surgical timing and intervention on outcome in traumatized dogs and cats. Peterson, NW., Buote, NJ., Barr, JW.[2018]

In a study involving 294 patients with acute traumatic spinal cord injury, early surgical decompression (within 12 hours) did not lead to statistically significant neurological improvements compared to late decompression (after 12 hours but within 14 days) after 12 months.

Despite early treatment showing a higher mean change in Lower Extremity Motor Score (LEMS), the difference was not clinically meaningful when accounting for baseline imbalances and other factors, emphasizing the need for careful statistical analysis in evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury. Hosman, AJF., Barbagallo, G., van Middendorp, JJ.[2023]

Early fasciotomy (within 12 hours) significantly reduces the risk of infection (7.3%) compared to late fasciotomy (after 12 hours) which has a higher infection rate (28%).

Despite the increased risk of infection with late fasciotomy, the rates of limb salvage and neurological outcomes remain similar to those of early fasciotomy, suggesting that fasciotomy is beneficial regardless of timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of early versus late fasciotomy in the management of extremity trauma. Williams, AB., Luchette, FA., Papaconstantinou, HT., et al.[2022]

Citations

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Patients who underwent MLKI reconstruction with limited access to rehabilitation demonstrated worse PROMIS pain and physical function scores than those with ...

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Impact of early vs. delayed physical therapy on functional ...

Early PT initiation significantly enhances functional recovery and proprioception without increasing the risk of graft failure or knee instability.

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According to Sadeqi et al., those who score ≥60 at 6 months postsurgery will likely return to the preinjury level at 2 years after surgery. Greater confidence ...

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Immediate Versus Optional Delayed Surgical Repair for ...

Moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of ...

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Delayed timing of physical therapy initiation increases the risk ...

Conclusion Compared with PT initiation within 1 month, delayed PT initiation was associated with higher risk of opioid use in people with incident knee OA. The ...

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Current best evidence indicates that early mobility achieves significantly better outcomes for stability, ROM and functional outcome compared with a period of ...

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49, p = 0.18). Patients who underwent delayed reconstruction demonstrated significantly higher physical function scores (46 vs. 53, p = 0.05).

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clinicaltrials.gov/study/NCT03543098

NCT03543098 | STaR Trial: Multiple Ligament Knee Injuries

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) ...