Weightbearing Strategies for Knee Injury Rehab

Overseen By Kayla Seiffert

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Twin Cities Orthopedics

Disqualifiers: Pregnancy, Age, Revision surgeries, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment for knee injury rehab?

Research shows that rehabilitation after ACL reconstruction, including physical therapy and specific exercise regimens, is effective in restoring knee function. Studies highlight the importance of achieving knee symmetry in motion and strength, with 100% of patients achieving normal knee extension and 97% achieving normal knee flexion using the Knee Symmetry Model. ^{1 2 3 4 5}

Is weightbearing after knee ligament reconstruction generally safe?

Knee ligament reconstruction, including ACL and FCL, is generally safe, but there is a small risk of infection and other complications. Early weightbearing protocols are not well defined for FCL reconstruction, but ACL reconstruction is common and considered safe with rare infections. ^{6 7 8 9 10}

What makes the Weightbearing Strategies for Knee Injury Rehab treatment unique?

This treatment is unique because it explores early weightbearing strategies specifically after fibular collateral ligament reconstruction, which is not well-defined compared to the more established early weightbearing protocols for ACL reconstruction. It aims to enhance rehabilitation by focusing on weightbearing exercises that protect the knee and improve neuromuscular function. ^{3 4 10 11 12}

Research Team

Robert F LaPrade, MD, PhD

Principal Investigator

Twin Cities Orthopedics

Eligibility Criteria

This trial is for males and females aged 14 to 60 who are undergoing fibular collateral ligament (FCL) reconstruction, with or without anterior cruciate ligament (ACL) surgery. Participants must be able to follow the study plan and give informed consent. It's not for those with certain other knee surgeries, pregnant individuals, under 14 or over 60 years old.

Inclusion Criteria

Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

I am between 14 and 59 years old.

I am either male or female.

Exclusion Criteria

I am younger than 14 or older than 60.

I am undergoing or have undergone repairs on my thigh muscle or outer knee capsule.

I am having or have had a revision of my FCL reconstruction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fibular collateral ligament reconstruction and follow one of two rehabilitation protocols: partial weightbearing or full controlled weightbearing for the first six weeks post-surgery.

6 weeks

Regular visits for rehabilitation monitoring

Follow-up

Participants are monitored for safety and effectiveness, including measurements of varus gapping, pain, edema, range of motion, and quadriceps strength.

10 months

Visits at 4, 7, and 10 months post-surgery

Long-term follow-up

Participants' outcomes are assessed through patient-reported outcome scores and other measures to evaluate long-term recovery.

1 year

Treatment Details

Interventions

• Anterior Cruciate Ligament Reconstruction
• Fibular Collateral Ligament Reconstruction
• Physical Therapy

Trial Overview The study is testing whether patients can safely start full weightbearing during the first six weeks of rehab after FCL reconstruction alone or combined with ACL surgery. This will be determined through a randomized controlled trial comparing full versus partial weightbearing.

Participant Groups

Group I: Full weight -bearing for the first six weeks after surgery Experimental Treatment 1 Intervention

If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.

Group II: Partial weight -bearing for the first six weeks after surgery Active Control 1 Intervention

Partial weightbearing will be defined as 40% of the patient's body weight.

Anterior Cruciate Ligament Reconstruction is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as ACL Reconstruction for:

• Knee instability due to ACL tear
• Combined ACL and meniscal injuries
• Chronic ACL deficiency

Approved in European Union as Anterior Cruciate Ligament Repair for:

• Knee instability due to ACL tear
• Combined ACL and meniscal injuries
• Chronic ACL deficiency
• Pediatric ACL injuries

Approved in Canada as ACL Reconstruction for:

• Knee instability due to ACL tear
• Combined ACL and meniscal injuries
• Chronic ACL deficiency

Approved in Japan as Anterior Cruciate Ligament Reconstruction for:

• Knee instability due to ACL tear
• Combined ACL and meniscal injuries

Who Is Running the Clinical Trial?

Twin Cities Orthopedics

Lead Sponsor

Trials

4

Recruited

930+

Findings from Research

Arthroscopic reconstruction of anterior cruciate ligament (ACL) tears offers significant advantages over traditional surgery, including reduced pain and quicker recovery, making it suitable for outpatient procedures.

The most effective graft for ACL reconstruction is the bone-patellar tendon-bone autograft, which has a tensile strength comparable to that of the original ligament, emphasizing the importance of proper graft selection and a comprehensive rehabilitation program for successful recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament injuries. Evaluation, arthroscopic reconstruction, and rehabilitation. Whittington, CF., Carlson, CA.[2016]

Rehabilitation after anterior cruciate ligament (ACL) reconstruction should focus on early passive motion, weight bearing, and specific exercises to enhance recovery, although more research is needed to establish precise timelines for these advancements.

Despite surgical reconstruction, many young patients struggle to return to high-level activities, highlighting the need for improved rehabilitation strategies and further evidence to optimize recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances following anterior cruciate ligament reconstruction: rehabilitation perspectives : Critical reviews in rehabilitation medicine. Manske, RC., Prohaska, D., Lucas, B.[2021]

The rehabilitation program after anterior cruciate ligament (ACL) reconstruction has been updated to incorporate new insights on isometric placement, revascularization, and biomechanical stresses, emphasizing the importance of tailored treatment protocols for each patient.

The program focuses on developing range of motion and strength while minimizing stress on the ligament substitute, particularly during end-range extension, to ensure a safe return to preinjury activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of the knee after anterior cruciate ligament reconstruction. Seto, JL., Brewster, CE., Lombardo, SJ., et al.[2019]

Accelerated and controlled rehabilitation for anterior cruciate ligament (ACL) injuries is increasingly recognized as effective, combining scientific data and clinical experience to guide treatment protocols.

The article discusses key rehabilitation strategies, including exercise, continuous passive motion, proprioceptive training, and knee bracing, which are essential for optimizing recovery in both reconstructed and non-reconstructed ACL knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of anterior cruciate ligament injuries. Halling, AH., Howard, ME., Cawley, PW.[2016]

The Knee Symmetry Model for ACL rehabilitation emphasizes achieving symmetric range of motion and strength, which has been linked to better patient outcomes after ACL reconstruction.

Preliminary results show that 100% of patients achieved normal knee extension and 97% achieved normal knee flexion using this model, indicating its potential effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation for Patients Following ACL Reconstruction: A Knee Symmetry Model. Biggs, A., Jenkins, WL., Urch, SE., et al.[2022]

An NBA player successfully returned to preinjury competition levels 9 months after undergoing surgical reconstruction for both anterior cruciate ligament (ACL) and fibular collateral ligament (FCL) injuries.

This case suggests that athletes can effectively return to high-level sports after a combined ACL and FCL reconstruction, indicating the potential for successful recovery from complex knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to National Basketball Association Competition Following Anterior Cruciate Ligament and Fibular Collateral Ligament Injuries: A Case Report. LaPrade, RF., O'Brien, L., Kennedy, NI., et al.[2022]

ACL reconstruction is a generally safe and effective procedure for knee stability, but infections, although rare, can lead to serious complications and poor outcomes.

Early diagnosis and treatment of infections with culture-specific antibiotics and debridement are crucial to prevent further damage to the knee, while the type of graft used does not appear to influence infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. Stucken, C., Garras, DN., Shaner, JL., et al.[2022]

FCL injuries can cause knee instability and lead to long-term issues like meniscal injuries and osteoarthritis, highlighting the importance of effective treatment.

The described surgical technique for FCL reconstruction using a semitendinosus graft is biomechanically validated and can be combined with other ligament reconstructions, potentially improving outcomes compared to traditional repair methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomic Fibular Collateral Ligament Reconstruction. Moatshe, G., Dean, CS., Chahla, J., et al.[2020]

In a study of 958 patients undergoing ACL reconstruction, the overall complication rate was 39%, with anterior knee pain, stiffness, and secondary meniscal lesions being the most common issues reported.

The patellar tendon graft showed a significantly lower rerupture rate compared to the hamstring graft (3.1% vs 7%), while complications related to hardware were more frequent in the hamstring group, suggesting that graft choice can impact postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. Rousseau, R., Labruyere, C., Kajetanek, C., et al.[2020]

A randomized controlled trial involving 39 patients showed that early partial weightbearing (40% body weight) after fibular collateral ligament (FCL) reconstruction did not negatively impact knee stability compared to nonweightbearing, with both groups showing similar outcomes in terms of lateral compartment laxity at 6 months post-surgery.

Patients who engaged in early partial weightbearing experienced significantly less knee edema compared to those who remained nonweightbearing, suggesting that early weightbearing may help reduce swelling without compromising recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial Controlled Early Postoperative Weightbearing Versus Nonweightbearing After Reconstruction of the Fibular (Lateral) Collateral Ligament: A Randomized Controlled Trial and Equivalence Analysis. LaPrade, RF., DePhillipo, NN., Cram, TR., et al.[2019]

In a study involving 7 patients two weeks post-ACL reconstruction and 7 healthy controls, both side-to-side and forward-backward body weight shift exercises were found to be effective for training weight acceptance without significant differences in anterior tibial translation in the ACL group.

The side-to-side exercise caused greater anterior translation in healthy controls compared to the forward-backward shift, suggesting that the type of exercise may influence knee stability differently in healthy individuals versus those recovering from ACL surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial translation in exercises used early in rehabilitation after anterior cruciate ligament reconstruction exercises to achieve weight-bearing. Kvist, J.[2016]

Rehabilitation for multiple-ligament knee injuries should focus on reducing pain and swelling, restoring range of motion, and enhancing strength and stability to improve overall function and minimize disability.

The rehabilitation program must be tailored to the individual, taking into account the specific ligament injuries and surgical procedures, with guidelines provided for various types of ligament reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of the multiple-ligament-injured knee. Irrgang, JJ., Fitzgerald, GK.[2022]

References

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

Anterior cruciate ligament injuries. Evaluation, arthroscopic reconstruction, and rehabilitation. [2016]

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

Recent advances following anterior cruciate ligament reconstruction: rehabilitation perspectives : Critical reviews in rehabilitation medicine. [2021]

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

Rehabilitation of the knee after anterior cruciate ligament reconstruction. [2019]

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

Rehabilitation of anterior cruciate ligament injuries. [2016]

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

Rehabilitation for Patients Following ACL Reconstruction: A Knee Symmetry Model. [2022]

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

Return to National Basketball Association Competition Following Anterior Cruciate Ligament and Fibular Collateral Ligament Injuries: A Case Report. [2022]

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

Infections in anterior cruciate ligament reconstruction. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Anatomic Fibular Collateral Ligament Reconstruction. [2020]

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

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. [2020]

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

Partial Controlled Early Postoperative Weightbearing Versus Nonweightbearing After Reconstruction of the Fibular (Lateral) Collateral Ligament: A Randomized Controlled Trial and Equivalence Analysis. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Tibial translation in exercises used early in rehabilitation after anterior cruciate ligament reconstruction exercises to achieve weight-bearing. [2016]

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

Rehabilitation of the multiple-ligament-injured knee. [2022]