Weightbearing Strategies After Knee Ligament Surgery for Knee Injuries

Overseen By Becky McGaver

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Twin Cities Orthopedics

Disqualifiers: Pregnancy, Vascular injury, Fractures, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 9 10 11}

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 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.

Exclusion Criteria

I am under 14 years old.

I am over 60 years old.

I have had a vascular bypass procedure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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

Group II: Non-weightbearing for the first six weeks after surgery Active Control 1 Intervention

Not weightbearing after surgery

Who Is Running the Clinical Trial?

Twin Cities Orthopedics

Lead Sponsor

Trials

4

Recruited

930+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 -0° to 0° and flexion from 90° to 130° 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The cognitive-behavioral-based physical therapy (CBPT-ACLR) intervention was found to be feasible and acceptable, with 88% of the 8 participants completing all sessions and reporting satisfaction with their recovery.

Significant improvements were observed in psychological factors related to recovery, with 88% of patients exceeding the minimal clinically important difference on the Tampa Scale of Kinesiophobia, indicating effective management of fear related to movement after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral-based physical therapy to enhance return to sport after anterior cruciate ligament reconstruction: An open pilot study. Coronado, RA., Sterling, EK., Fenster, DE., et al.[2020]

In a randomized clinical trial with 76 participants aged 20-40 who underwent ACL reconstruction, neuromuscular training was found to significantly reduce pain and improve function, strength, power, and quality of life compared to strength training.

The study demonstrated that neuromuscular training had statistically significant benefits (p<0.001 for pain, function, power, and strength; p=0.001 for quality of life), highlighting its effectiveness as a rehabilitation approach post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Training following Anterior Cruciate Ligament reconstruction - Pain, Function, Strength, Power & Quality of Life Perspective: A Randomized Control Trial. Khalid, K., Anwar, N., Saqulain, G., et al.[2022]

A systematic review of 10 studies involving 3271 participants found that additional physiotherapy interventions, such as Kinesio Taping and Whole-body vibration, significantly improved pain, edema, range of motion (ROM), muscle strength, and knee function in early postoperative rehabilitation after ACL reconstruction.

The review indicated that these physiotherapy interventions are generally safe, with no adverse events reported in most studies, highlighting their potential for enhancing recovery without increasing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACL Reconstruction: Which Additional Physiotherapy Interventions Improve Early-Stage Rehabilitation? A Systematic Review. Kochman, M., Kasprzak, M., Kielar, A.[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]

A comprehensive four-phase rehabilitation program, initiated at the time of injury and continuing post-surgery, has been effective in reducing complications and facilitating a quicker return to activity for patients undergoing anterior cruciate ligament reconstruction.

The program emphasizes early intervention strategies such as swelling reduction and gait training before surgery, followed by a focus on regaining knee motion and strengthening after surgery, which supports safe recovery and improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perioperative rehabilitation program for anterior cruciate ligament surgery. Arnold, T., Shelbourne, KD.[2010]

A graduated treatment approach for fresh knee-joint ligament injuries effectively reduces pain, restores mobility, and increases muscular strength by gradually increasing joint mobility and static loading.

Incorporating physiotherapeutic techniques, such as proprioceptive exercises and electrical stimulation, is essential for recovery, while early complications like infection and mobility stagnation must be actively managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early complications, concomitant and follow-up treatment of fresh combined knee ligament injuries]. Wentzensen, A.[2008]

Reconstructive surgery for knee ligament injuries requires a high level of surgical skill and a structured postoperative rehabilitation plan that typically lasts 12 months, emphasizing gradual recovery.

The rehabilitation process is divided into phases: the first 6 weeks focus on healing, the next 6 weeks on improving muscle strength and mobility, and after 12 weeks, the goal is to regain full strength and coordination, preparing the patient for sports activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[After-care in surgical replacement of the ligaments of the knee joint]. Bereiter, H., Grossmann, S.[2008]

The study involved 57 cases of knee ligament injuries treated between 1975 and 1978, highlighting the importance of tailored therapeutic procedures and surgical indications for effective recovery.

Intensive physiotherapy following surgery was emphasized as a crucial component for successful rehabilitation and recovery of knee function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of new knee joint ligament injuries in the regional hospital]. Frick, E., Blatter, R.[2006]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Is physical therapy more beneficial than unsupervised home exercise in treatment of post surgical knee disorders? A systematic review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Outcome of surgical treatment of arthrofibrosis following ligament reconstruction. [2021]

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

The effects of the number and frequency of physical therapy treatments on selected outcomes of treatment in patients with anterior cruciate ligament reconstruction. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral-based physical therapy to enhance return to sport after anterior cruciate ligament reconstruction: An open pilot study. [2020]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Neuromuscular Training following Anterior Cruciate Ligament reconstruction - Pain, Function, Strength, Power & Quality of Life Perspective: A Randomized Control Trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

ACL Reconstruction: Which Additional Physiotherapy Interventions Improve Early-Stage Rehabilitation? A Systematic Review. [2022]

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

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

8. England pubmed.ncbi.nlm.nih.gov

A perioperative rehabilitation program for anterior cruciate ligament surgery. [2010]

9. Germany pubmed.ncbi.nlm.nih.gov

[Early complications, concomitant and follow-up treatment of fresh combined knee ligament injuries]. [2008]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[After-care in surgical replacement of the ligaments of the knee joint]. [2008]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Treatment of new knee joint ligament injuries in the regional hospital]. [2006]