3D Printed Knee Extender for ACL Injury

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D-printed knee extender device designed to aid recovery from ACL surgery. It aims to determine if using this device, alongside a home rehab program, improves recovery compared to standard rehab alone. The trial targets individuals with an ACL rupture, allowing other knee issues as long as the primary concern is the torn ACL. Participants must be prepared to adhere to the study’s guidelines. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for future patients.

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 prior data suggests that this 3D printed knee extender is safe for knee rehabilitation?

Research has shown that 3D printed knee devices, like the one tested in this study, are generally well-accepted by users. Studies have found that these custom braces can improve knee function and comfort, which is crucial for individuals recovering from ACL surgery. They may also help prevent further injuries and reduce the risk of developing arthritis later on.

Similar studies have reported no major safety issues or serious side effects. Since this type of treatment is in the "Not Applicable" phase, the focus is on evaluating the device's effectiveness rather than conducting early safety tests. This indicates that the device is already considered safe enough for trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard rehabilitation techniques for ACL injuries, which often involve physical therapy sessions and generalized braces or supports, the 3D Printed Customized Knee Extender introduces a personalized approach. This device is tailored to fit each individual's knee anatomy, potentially enhancing comfort and effectiveness. Researchers are excited about this treatment because it combines cutting-edge 3D printing technology with an at-home rehabilitation program, offering a more convenient and potentially more effective recovery process. This innovation could lead to faster recovery times and improved outcomes by providing a custom fit that traditional options lack.

What evidence suggests that this 3D printed knee extender is effective for ACL rehabilitation?

Research shows that 3D-printed knee devices might improve knee function and comfort after ACL surgery. Studies suggest they could enhance muscle performance, leading to better knee control and reduced weakness. Some research also hints that these devices might prevent further injuries and lower the risk of developing arthritis later. In this trial, participants will use a 3D-printed knee extender device as part of an at-home rehabilitation program. However, a review of several studies found no strong proof that knee braces in general significantly impact recovery after ACL surgery. This indicates that the effectiveness of the 3D-printed knee extender is still under investigation. ^{1 2 3 4 5}

Who Is on the Research Team?

Nathan Skelley, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

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

Able and willing to adhere to the study procedures

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

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

Exclusion Criteria

Pregnancy

Non-English speaking

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06524349?draw=2&rank=1

Utilization of a 3D Printed Customized Knee Extender and ... 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 ...

2. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-injuries-5-2024-89807

3D Printed Knee Extender for ACL Injury · Info for Participants A meta-analysis of clinical and experimental studies found no evidence that knee braces improve postoperative outcomes after anterior cruciate ligament (ACL) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40358087/

The role of a custom 3D-printed knee brace It may help prevent further injury and reduce the risk of post-traumatic osteoarthritis development. The long-term effects of brace use in ACL ...

4. biorxiv.org biorxiv.org/content/10.1101/2024.07.04.601890v1.full-text

The Role of a Custom 3D Printed Knee Brace Increased rectus femoris activation during early stance phase could improve knee function and stability, acting against quadriceps weakness ...

5. researchgate.net researchgate.net/publication/386082349_Development_and_Analysis_of_3D-Printed_Knee_Orthosis_for_Post-Anterior_Cruciate_Ligament_Injuries_Rehabilitation

Development and Analysis of 3D-Printed Knee Orthosis for ... Development and Analysis of 3D-Printed Knee Orthosis for Post-Anterior Cruciate Ligament Injuries Rehabilitation. October 2024; Proceedings of ...