28 Participants Needed

3D Printed Knee Extender for ACL Injury

Recruiting at 1 trial location
KJ
Overseen ByKatie Jensen
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Sanford Health
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.

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.12345

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.25678

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

NS

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
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D printed knee extender deviceExperimental Treatment1 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 RehabilitationActive Control1 Intervention

Find a Clinic Near You

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.
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.
[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 36ยฐ to a final extension of 1.4ยฐ, indicating that this device, combined with specialized physical therapy, is a safe and effective intervention with minimal need for additional surgical procedures.
Custom Knee Device for Knee Contractures After Internal Femoral Lengthening.Bhave, A., Shabtai, L., Ong, PH., et al.[2018]

References

Evaluation of a custom device for the treatment of flexion contractures after total knee arthroplasty. [2021]
[To brace or not to brace? How effective are knee braces in rehabilitation?]. [2022]
Custom Knee Device for Knee Contractures After Internal Femoral Lengthening. [2018]
To brace or not to brace? How effective are knee braces in rehabilitation? [2019]
Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair. [2021]
Most british surgeons would consider using a tissue-engineered anterior cruciate ligament: a questionnaire study. [2021]
Functional Brace in ACL Surgery: Force Quantification in an In Vivo Study. [2022]
Dynamically tensioned ACL functional knee braces reduce ACL and meniscal strain. [2018]
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