3D Printed Knee Extender for ACL Injury
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byNathan Skelley, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sanford Health
Disqualifiers: Pregnancy, Non-English speaking
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345How 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.
25678Eligibility 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
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Sanford Orthopedics and Sports MedicineFargo, ND
Sanford Orthopedics and Sports MedicineSioux Falls, SD
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Who Is Running the Clinical Trial?
Sanford HealthLead Sponsor
References
Evaluation of a custom device for the treatment of flexion contractures after total knee arthroplasty. [2021]Knee flexion contractures can severely impair function after total knee arthroplasties. We evaluated the use of a custom-molded knee device to treat 47 patients who had knee flexion contractures (mean, 22 degrees; range, 10 degrees-40 degrees) after primary or revision total knee arthroplasties and who had failed conventional therapeutic methods. The device was used for 30 to 45 minutes per session two to three times per day in conjunction with standard physical therapy modalities two to three times per week. Twenty-seven of 29 patients who underwent primary total knee arthroplasty and 13 of 18 patients who underwent revisions achieved full extension after a mean treatment time of 9 weeks (range, 6-16 weeks). Full knee extension was maintained at a minimum followup of 18 months (mean, 24 months; range, 18-36 months). The mean Knee Society knee and functional scores improved from 50 points and 34 points to 91 points and 89 points, respectively. This protocol had comparable rates of improvement in knee extension with less treatment time when compared with other nonoperative treatments reported in the literature. The custom knee device may be a useful adjunct to a physical therapy regimen for knee flexion contractures after total knee arthroplasty.
[To brace or not to brace? How effective are knee braces in rehabilitation?]. [2022]Since the clinical benefit of knee braces has yet to be defined, discussion about braces after reconstructive surgery of the anterior cruciate ligament remains controversial. The use of prophylactic braces in sport did not prove to be effective. In ACL insufficient knee joints, the operative treatment is preferred over the use of functional knee braces. Therefore, the postoperative rehabilitation presents the main application of braces. Modern operative techniques with an initial strong fixation of the ACL graft make a functional postoperative treatment without external fixation possible. In the presented meta-analysis of the literature about knee braces, results from clinical and experimental studies are compared. No published clinical data have shown that braces have any effect on postoperative outcome after ACL-reconstruction. Also, no evidence of a significant bracing effect could be demonstrated in the experimental in vivo or in vitro studies, except a limited stabilizing function for lower shear stress below the physiological loads. Consequently, the systematic use of braces in the rehabilitation after ACL reconstruction cannot be recommended.
Custom Knee Device for Knee Contractures After Internal Femoral Lengthening. [2018]The development of knee flexion contractures is among the most common problems and complications associated with lengthening the femur with an internal device or external fixator. Conservative treatment strategies include physical therapy, serial casting, and low-load prolonged stretching with commercially available splinting systems. The authors developed an individually molded, low-cost custom knee device with polyester synthetic conformable casting material to treat knee flexion contractures. The goal of this study was to evaluate the results of treatment with a custom knee device and specialized physical therapy in patients who had knee flexion contracture during femoral lengthening with an intramedullary lengthening femoral nail. This retrospective study included 23 patients (27 limbs) who underwent femoral lengthening with an internal device for the treatment of limb length discrepancy. All patients had a knee flexion contracture raging from 10° to 90° during the lengthening process and were treated with a custom knee device and specialized physical therapy. The average flexion contracture before treatment was 36°. The mean amount of lengthening was 5.4 cm. After an average of 3.8 weeks of use of the custom knee device, only 2 of 27 limbs (7.5%) had not achieved complete resolution of the flexion contracture. The average final extension was 1.4°. Only 7 of 27 limbs (26%) required additional soft tissue release. The custom knee device is an inexpensive and effective method for treating knee flexion contracture after lengthening with an internal device.
To brace or not to brace? How effective are knee braces in rehabilitation? [2019]Since the clinical benefit of knee braces has yet to be defined, discussion about braces after reconstructive surgery of the anterior cruciate ligament remains controversial. The use of prophylactic braces in sport did not prove to be effective. In ACL insufficient knee joints, the operative treatment is preferred over the use of functional knee braces. Therefore, the postoperative rehabilitation presents the main application of braces. Modern operative techniques with an initial strong fixation of the ACL graft make a functional postoperative treatment without external fixation possible. In the presented metaanalysis of the literature about knee braces, results from clinical and experimental studies are compared. No published clinical data have shown that braces have any effect on postoperative outcome after ACL-reconstruction. Also, no evidence of a significant bracing effect could be demonstrated in the experimental in vivo or in vitro studies, except a limited stabilizing function for lower shear stress below the physiological loads. Consequently, the systematic use of braces in the rehabilitation after ACL reconstruction cannot be recommended.
Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair. [2021]Anterior cruciate ligament (ACL) injuries are one of the most well-known orthopaedic injuries and are treated with one of the most common orthopaedic procedures performed in the United States. This surgical procedure, ACL reconstruction, is successful at restoring the gross stability of the knee. However, the outcomes of ACL reconstruction can be limited by short and long-term complications, including muscle weakness, graft rupture, and premature osteoarthritis. Thus, new methods of treating this injury are being explored. This review details the pathway of how a tissue engineering strategy can be used to improve the healing of the ACL in preclinical studies and then translated to patients in an FDA-approved clinical study. This review paper will outline the clinical importance of ACL injuries, history of primary repair, the pathology behind failure of the ACL to heal, pre-clinical studies, the FDA approval process for a high risk medical device, and the preliminary results from a first-in-human study. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2606-2612, 2017.
Most british surgeons would consider using a tissue-engineered anterior cruciate ligament: a questionnaire study. [2021]Donor site morbidity, poor graft site integration, and incorrect mechanical performance are all common problems associated with autografts for anterior cruciate ligament (ACL) reconstructions. A tissue-engineered (TE) ligament has the potential to overcome these problems. We produced an online questionnaire relating to tissue engineering of the ACL to obtain input from practising clinicians who currently manage these injuries. 300 British orthopaedic surgeons specialising in knee surgery and soft tissue injury were invited to participate. 86% of surgeons would consider using a TE ACL if it were an option, provided that it showed biological and mechanical success, if it significantly improved the patient satisfaction (63%) or shortened surgical time (62%). 76% felt that using a TE ACL would be more appropriate than a patellar tendon, hamstring, or quadriceps autograft. Overall, most surgeons would be prepared to use a TE ACL if it were an improvement over the current techniques.
Functional Brace in ACL Surgery: Force Quantification in an In Vivo Study. [2022]A need exists for a functional anterior cruciate ligament (ACL) brace that dynamically supports the knee joint to match the angle-dependent forces of a native ACL, especially in the early postoperative period.
Dynamically tensioned ACL functional knee braces reduce ACL and meniscal strain. [2018]The effectiveness of ACL functional knee braces to reduce meniscal and ACL strain after ACL injury or reconstruction is not well understood. A new dynamic knee tensioning brace system has been designed to apply an active stabilizing force to the knee. The ability of this system to reduce tissue strains is unknown. The purpose of this study was to test the ability of the dynamically tensioned brace to reduce strain in both the ACL and meniscus during rehabilitation activities.