3D Printed Knee Extender for ACL Injury

Recruiting at 1 trial location

Overseen By Katie Jensen

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sanford Health

Disqualifiers: Pregnancy, Non-English speaking

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: Unknown

Duration: 6 weeks

28 Participants Needed

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.

What data supports the effectiveness of the 3D Printed Customized Knee Extender treatment for ACL injury?

Research on custom knee devices for other knee issues, like knee flexion contractures, shows that these devices can help improve knee extension and function. However, studies on knee braces specifically for ACL injuries suggest they may not significantly impact recovery after ACL surgery. ^{1 2 3 4 5}

How does the 3D Printed Knee Extender for ACL Injury differ from other treatments?

The 3D Printed Knee Extender is unique because it likely offers a customized fit and dynamic support tailored to the individual's knee anatomy, potentially improving rehabilitation outcomes compared to standard braces or surgical options. This approach may address limitations of traditional ACL treatments, such as poor graft integration and mechanical performance issues. ^{2 5 6 7 8}

What is the purpose of this trial?

The purpose of this study is to explore patient outcomes associated with, the use of a 3D printed knee extender device, in conjunction with an at-home rehabilitation program, for patients who are performing knee rehabilitation after anterior cruciate ligament (ACL) surgery.

Research Team

Nathan Skelley, MD

Principal Investigator

Sanford Health

Eligibility Criteria

This trial is for individuals recovering from ACL surgery. Participants should be following a home rehabilitation program and willing to use a new 3D printed knee extender device designed to aid in their recovery.

Inclusion Criteria

I have a torn ACL and may have other knee issues, but the ACL tear is the main reason for surgery.

Able and willing to adhere to the study procedures

Able to consent for self-, or able to assent for self with parental consent

Exclusion Criteria

Pregnancy

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants utilize a 3D printed knee extender device and an at-home rehabilitation program for knee rehabilitation after ACL surgery

6 weeks

Weekly follow-up surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including knee extension range of motion and knee swelling

4 weeks

Treatment Details

Interventions

• 3D Printed Customized Knee Extender

Trial Overview The study tests the effectiveness of a custom-made 3D printed knee extender used alongside an at-home rehab plan, aiming to improve outcomes for patients after ACL surgery.

Participant Groups

Group I: 3D printed knee extender device Experimental Treatment 1 Intervention

Participants will utilize a 3D printed knee extender device and an at-home home rehabilitation program designed to be used with the 3D printed knee extender device.

Group II: Standard Rehabilitation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

Findings from Research

A custom-molded knee device effectively treated knee flexion contractures in 47 patients after total knee arthroplasties, with 27 of 29 primary and 13 of 18 revision patients achieving full extension after an average of 9 weeks.

The treatment led to significant improvements in knee function, with Knee Society scores increasing from an average of 50 to 91 points, and these gains were maintained for at least 18 months, suggesting the device is a valuable addition to physical therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a custom device for the treatment of flexion contractures after total knee arthroplasty. McGrath, MS., Mont, MA., Siddiqui, JA., et al.[2021]

A meta-analysis of clinical and experimental studies found no evidence that knee braces improve postoperative outcomes after anterior cruciate ligament (ACL) reconstruction, suggesting their use in rehabilitation is not beneficial.

While braces may provide limited stabilization under low shear stress, they are not effective for ACL insufficient knee joints, and modern surgical techniques allow for rehabilitation without the need for external fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[To brace or not to brace? How effective are knee braces in rehabilitation?]. Martinek, V., Friederich, NF.[2022]

A custom knee device, made from low-cost materials, effectively treated knee flexion contractures in 23 patients undergoing femoral lengthening, with 92.5% of limbs achieving complete resolution after an average of 3.8 weeks.

The average knee flexion contracture improved from 36° to a final extension of 1.4°, indicating that this device, combined with specialized physical therapy, is a safe and effective intervention with minimal need for additional surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom Knee Device for Knee Contractures After Internal Femoral Lengthening. Bhave, A., Shabtai, L., Ong, PH., et al.[2018]

A meta-analysis of literature on knee braces after anterior cruciate ligament (ACL) reconstruction found no clinical evidence supporting their effectiveness in improving postoperative outcomes, based on various studies.

The analysis indicated that while braces may provide limited stabilization under low shear stress, their systematic use in rehabilitation after ACL surgery is not recommended, as modern surgical techniques allow for effective recovery without them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To brace or not to brace? How effective are knee braces in rehabilitation? Martinek, V., Friederich, NF.[2019]

ACL reconstruction surgery is effective in restoring knee stability but can lead to complications such as muscle weakness and premature osteoarthritis, highlighting the need for improved treatment methods.

The review discusses a promising tissue engineering strategy that has shown potential in preclinical studies and is being translated into clinical practice, with preliminary results from an FDA-approved study indicating progress in ACL healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair. Perrone, GS., Proffen, BL., Kiapour, AM., et al.[2021]

A survey of 300 British orthopedic surgeons revealed that 86% would consider using a tissue-engineered anterior cruciate ligament (TE ACL) if it demonstrated biological and mechanical success, indicating strong interest in this innovative approach.

76% of surgeons believed that a TE ACL would be a better option than traditional autografts, such as patellar tendon or hamstring grafts, suggesting a significant potential for improved patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Most british surgeons would consider using a tissue-engineered anterior cruciate ligament: a questionnaire study. Rathbone, S., Maffulli, N., Cartmell, SH.[2021]

The dynamic force ACL brace applied significantly larger posteriorly directed forces to the anterior proximal tibia during functional activities compared to the static force brace, suggesting better support for the knee joint in early postoperative recovery.

This study indicates that a dynamic brace may more closely mimic the natural function of the ACL, potentially leading to improved treatment outcomes for patients recovering from ACL injuries, although further research is needed to confirm its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Brace in ACL Surgery: Force Quantification in an In Vivo Study. LaPrade, RF., Venderley, MB., Dahl, KD., et al.[2022]

The dynamic knee tensioning brace significantly reduced peak and average meniscal strain in ACL-deficient knees by an average of 1.7%, suggesting it may help prevent further meniscal injuries during rehabilitation activities.

The brace also lowered ACL strain in both intact and reconstructed knees, indicating its potential role in protecting the ACL graft and preventing injuries in patients with unstable knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamically tensioned ACL functional knee braces reduce ACL and meniscal strain. Tomescu, S., Bakker, R., Wasserstein, D., et al.[2018]

References

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

Evaluation of a custom device for the treatment of flexion contractures after total knee arthroplasty. [2021]

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

[To brace or not to brace? How effective are knee braces in rehabilitation?]. [2022]

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

Custom Knee Device for Knee Contractures After Internal Femoral Lengthening. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

To brace or not to brace? How effective are knee braces in rehabilitation? [2019]

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

Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair. [2021]

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

Most british surgeons would consider using a tissue-engineered anterior cruciate ligament: a questionnaire study. [2021]

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

Functional Brace in ACL Surgery: Force Quantification in an In Vivo Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Dynamically tensioned ACL functional knee braces reduce ACL and meniscal strain. [2018]