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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to help people recover from knee surgery involving ligaments. It examines whether patients can safely put full weight on their leg immediately after surgery or if they should only partially bear weight. The study focuses on two types of knee surgeries: one for the fibular collateral ligament (FCL) and another for both the FCL and the anterior cruciate ligament (ACL). People who have recently undergone these surgeries and are ready to follow the trial plan might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to valuable research that could enhance recovery protocols for future knee surgery patients.

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 prior data suggests that these weightbearing strategies are safe for knee injury rehab?

Research has shown that starting to put weight on the leg soon after ACL (anterior cruciate ligament) surgery is usually safe, though some risks exist. One study found that about 17% of patients experienced issues with the new ligament, and about 6% developed infections. These factors are important to consider. However, many individuals do return to sports, with about 80% resuming some activity, though only about 65% reach their pre-injury level.

For recovery, some studies suggest that a quicker approach can reduce knee pain and improve knee function. Moving normally sooner might benefit some individuals. Always weigh the risks and benefits and consult with a doctor to determine the best plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative rehabilitation strategies for knee injuries, specifically after ligament reconstruction. Unlike traditional rehab approaches, which often emphasize partial weight-bearing, this trial compares it with a full weight-bearing strategy right after surgery. The idea is to see if allowing patients to bear their full weight sooner can improve recovery times and outcomes. If successful, this could shift the current rehab practices and provide more effective recovery options for those undergoing knee surgeries.

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

Research has shown mixed results on when to start weight-bearing after ACL surgery. Some studies suggest that avoiding weight-bearing for the first three weeks may lead to better medium-term recovery. However, other studies indicate that carefully starting weight-bearing can be safe and might speed up recovery. In this trial, participants will join either a partial weight-bearing group or a full weight-bearing group for the first six weeks post-surgery. The FCL surgery receives less attention on its own, but performing both FCL and ACL surgeries together with controlled weight-bearing might enhance knee function. Overall, experts continue to study the best way to balance healing and recovery after these surgeries. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert F LaPrade, MD, PhD

Principal Investigator

Twin Cities Orthopedics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11106972/

The impact of early weight-bearing on results following ... In our study, we found that patients who followed a non-weight-bearing regimen for 3 weeks after surgery had better mid-term results than those ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11168252/

Clinical Results of Primary Repair Versus Reconstruction of ... A meta-analysis of comparative trials to determine whether differences in clinical outcomes and adverse events exist between ACL repair versus ACLR.

3. bjsm.bmj.com bjsm.bmj.com/content/57/9/500

Aspetar clinical practice guideline on rehabilitation after ... This guideline was developed to inform clinical practice on rehabilitation after anterior cruciate ligament reconstruction (ACLR)

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X21002315

Anterior Cruciate Ligament Rehabilitation and Return to ... Some positives of a conservative approach include increased healing time, less stress to the graft earlier in the rehabilitation timeline, and possibly a ...

5. researchgate.net researchgate.net/publication/380756520_The_impact_of_early_weight-bearing_on_results_following_anterior_cruciate_ligament_reconstruction

The impact of early weight-bearing on results following ... The aim of this article is to examine the impact of weight-bearing on the clinical results of ACL reconstruction. Materials and methods We ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9460090/

ACL Reconstruction Rehabilitation: Clinical Data, Biologic ... Our clinical data support the timeline of 4 weeks to achieve full active knee extension, irrespective of concomitant meniscal procedures. This is in agreement ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059775421000055

Outcomes of single bundle arthroscopic anterior cruciate ... The overall graft failure and infection rates were 17.2% and 6.2%, respectively, and the revision rate was higher in the urban group. Introduction. The most ...

8. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/12296/45449

Functional outcomes of accelerated rehabilitation protocol ... The results showed that an accelerated rehabilitation protocol may improve knee pain and functional outcomes in amateur athletes with anterior ...