50 Participants Needed

Weightbearing Strategies After Knee Ligament Surgery for Knee Injuries

KS
BM
Overseen ByBecky McGaver
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Twin Cities Orthopedics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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 this treatment for knee injuries?

Research suggests that a structured physical therapy program after knee ligament surgery can lead to successful outcomes, even with a limited number of therapy visits. Additionally, for young and healthy individuals, home exercise programs can be as effective as supervised physical therapy for simple knee surgeries.12345

Is physical therapy safe after knee ligament surgery?

Physical therapy, including various additional interventions, is generally safe for humans after knee ligament surgery, with most studies reporting no adverse events.13678

How is the treatment of physical therapy unique for knee ligament surgery recovery?

Physical therapy for knee ligament surgery recovery is unique because it involves a structured program that gradually increases joint mobility and muscle strength, while also incorporating techniques like proprioceptive exercises, electrical stimulation, and isokinetic training to enhance recovery. This approach is tailored to avoid complications like ligament slackening and stagnating mobility, making it distinct from unsupervised home exercises.1691011

What is the purpose of this trial?

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.

Research Team

RF

Robert F LaPrade, MD, PhD

Principal Investigator

Twin Cities Orthopedics

Eligibility Criteria

This trial is for individuals aged between 14 and 60 who have had surgery to repair a knee ligament injury, such as the PCL alone or in combination with other ligaments like ACL and MCL. Participants must be able to follow the study plan and give informed consent. It's not open to those with certain concurrent surgeries, previous vascular injuries, pregnant women, or anyone needing revision PCL reconstructions.

Inclusion Criteria

I have had surgery to repair both my ACL and MCL.
Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
I am either male or female.
See 4 more

Exclusion Criteria

I am under 14 years old.
I am over 60 years old.
I have had a vascular bypass procedure.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either non-weightbearing or partial weightbearing rehabilitation for the first six weeks after knee ligament reconstruction surgery

6 weeks
Weekly visits for rehabilitation assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of posterior tibial translation and compartment gapping

6 months
Visits at 4, 7, and 10 months for physical therapy assessments

Long-term follow-up

Participants complete patient-reported outcome surveys and additional assessments

1 year
Visits at 3 months, 6 months, and 1 year

Treatment Details

Interventions

  • Physical Therapy
Trial Overview The study is testing whether patients can safely start partial controlled weightbearing during the first six weeks after reconstructive knee surgery. This involves comparing two approaches: non-weightbearing versus partial weightbearing post-surgery through randomized assignment of participants.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Partial weight -bearing for the first six weeks after surgeryExperimental Treatment1 Intervention
Partial weightbearing will be defined as 40% of the patient's body weight.
Group II: Non-weightbearing for the first six weeks after surgeryActive Control1 Intervention
Not weightbearing after surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Twin Cities Orthopedics

Lead Sponsor

Trials
4
Recruited
930+

Findings from Research

In a systematic review of 10 randomized control trials, it was found that supervised physical therapy after simple knee surgeries, like arthroscopic meniscectomy, does not provide additional benefits compared to home exercise programs for young and healthy patients.
However, the evidence is insufficient to determine the effectiveness of supervised therapy for older patients or those with more complex knee surgeries, indicating a need for further research in these groups.
Is physical therapy more beneficial than unsupervised home exercise in treatment of post surgical knee disorders? A systematic review.Coppola, SM., Collins, SM.[2022]
Surgical treatment for arthrofibrosis following knee-ligament reconstruction, combined with intensive physiotherapy, significantly improved patients' range of motion, with extension deficits improving from -0ยฐ to 0ยฐ and flexion from 90ยฐ to 130ยฐ over a median follow-up of 51 months.
Despite the improvements in range of motion, subjective outcome scores indicated relatively poor recovery compared to patients without complications, with predictors of poor outcomes including global arthrofibrosis and delays of more than 6 months between the initial surgery and the release procedure.
Outcome of surgical treatment of arthrofibrosis following ligament reconstruction.Said, S., Christainsen, SE., Faunoe, P., et al.[2021]
A study comparing two groups of 100 patients each after ACL reconstruction found that both groups achieved similar outcomes in terms of range of motion, strength, and subjective ratings, despite one group attending significantly more physical therapy visits (20 vs. 7).
The only notable difference was in hyperextension, where Group A had better results, suggesting that a structured home exercise program can lead to successful recovery even with fewer physical therapy sessions.
The effects of the number and frequency of physical therapy treatments on selected outcomes of treatment in patients with anterior cruciate ligament reconstruction.De Carlo, MS., Sell, KE.[2022]

References

Is physical therapy more beneficial than unsupervised home exercise in treatment of post surgical knee disorders? A systematic review. [2022]
Outcome of surgical treatment of arthrofibrosis following ligament reconstruction. [2021]
The effects of the number and frequency of physical therapy treatments on selected outcomes of treatment in patients with anterior cruciate ligament reconstruction. [2022]
Cognitive-behavioral-based physical therapy to enhance return to sport after anterior cruciate ligament reconstruction: An open pilot study. [2020]
Neuromuscular Training following Anterior Cruciate Ligament reconstruction - Pain, Function, Strength, Power & Quality of Life Perspective: A Randomized Control Trial. [2022]
ACL Reconstruction: Which Additional Physiotherapy Interventions Improve Early-Stage Rehabilitation? A Systematic Review. [2022]
Rehabilitation of the multiple-ligament-injured knee. [2022]
A perioperative rehabilitation program for anterior cruciate ligament surgery. [2010]
[Early complications, concomitant and follow-up treatment of fresh combined knee ligament injuries]. [2008]
[After-care in surgical replacement of the ligaments of the knee joint]. [2008]
[Treatment of new knee joint ligament injuries in the regional hospital]. [2006]
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