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

690 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Timing of Surgery and Rehab for Knee Injuries?

Research on other conditions suggests that early surgery may reduce complications, but studies on fractures and spinal injuries show no significant difference in outcomes between early and delayed surgery. This implies that the timing of surgery and rehabilitation for knee injuries might not significantly impact recovery outcomes. ^{1 2 3 4 5}

Is it safe to delay surgery and rehabilitation for knee injuries?

Research on other conditions suggests that delaying surgery does not significantly increase infection rates or the need for additional procedures, as seen in studies on tibial fractures. However, some studies indicate that delayed surgery can lead to poor outcomes in certain cases, like femoral neck fractures, so the safety may depend on the specific condition and timing. ^{1 2 3 6 7}

How does the timing of surgery affect outcomes for knee injuries?

The timing of surgery for knee injuries, whether early or delayed, can significantly impact recovery. Early surgery (within 2-3 weeks of injury) often leads to better stability and less pain compared to delayed surgery, which may result in poorer functional outcomes and increased pain. ^{1 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

James J Irrgang, PT PhD FAPTA

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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 cannot put weight on my uninjured leg.

My brain injury affects my ability to care for myself after surgery.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

References

1. Nigeria pubmed.ncbi.nlm.nih.gov

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

2. Germany 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. [2021]

3. Netherlands 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of surgical timing and intervention on outcome in traumatized dogs and cats. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury. [2023]

6. United States 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. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of early versus late fasciotomy in the management of extremity trauma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Early operative reconstruction of severe ligamentous knee injuries in patients with multiple trauma. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Time to talk? Patient experiences of waiting for clinical management of knee injuries. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Early or delayed reconstruction in multi-ligament knee injuries: A systematic review and meta-analysis. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Surgery Performed Less Than 3 Weeks After Injury Is Not Inferior to Delayed Surgery. [2021]