50 Participants Needed

Weightbearing Strategies for Knee Injury Rehab

BS
KS
Overseen ByKayla Seiffert
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Twin Cities Orthopedics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.34101112

Research Team

RF

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.
See 2 more

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.
See 3 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Full weight -bearing for the first six weeks after surgeryExperimental Treatment1 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 surgeryActive Control1 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

Find a Clinic Near You

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

References

Anterior cruciate ligament injuries. Evaluation, arthroscopic reconstruction, and rehabilitation. [2016]
Recent advances following anterior cruciate ligament reconstruction: rehabilitation perspectives : Critical reviews in rehabilitation medicine. [2021]
Rehabilitation of the knee after anterior cruciate ligament reconstruction. [2019]
Rehabilitation of anterior cruciate ligament injuries. [2016]
Rehabilitation for Patients Following ACL Reconstruction: A Knee Symmetry Model. [2022]
Return to National Basketball Association Competition Following Anterior Cruciate Ligament and Fibular Collateral Ligament Injuries: A Case Report. [2022]
Infections in anterior cruciate ligament reconstruction. [2022]
Anatomic Fibular Collateral Ligament Reconstruction. [2020]
Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. [2020]
10.United Statespubmed.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]
Tibial translation in exercises used early in rehabilitation after anterior cruciate ligament reconstruction exercises to achieve weight-bearing. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Rehabilitation of the multiple-ligament-injured knee. [2022]