Custom 3D-Printed Splints for Hyperextended Fingers

No longer recruiting at 2 trial locations

Overseen By Natasha Irani, OTD, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endeavor Health

Disqualifiers: Non-fluent in English, Decisionally impaired, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new custom 3D-printed splints for individuals with hyperextended fingers, where the finger bends back more than usual. The goal is to determine if these new splints outperform traditional ones by assessing user satisfaction and finger function after one month of use. Participants will be divided into two groups: one will use the 3D-printed splints, and the other will use conventional splints, such as thermoplastic finger splints or stack splints. The trial seeks individuals with a hyperextended finger condition who can comfortably wear a splint for a month.

As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance splint options for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these 3D-printed finger splints are safe for use?

Research has shown that custom 3D-printed finger splints are generally safe. Studies, particularly those on mallet finger injuries, report no skin irritation or other side effects, indicating that the splints are well-tolerated. Participants in these studies used the 3D-printed splints without major problems, suggesting they could be a comfortable and effective alternative to traditional splints. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about custom 3D-printed splints for hyperextended fingers because they offer a tailored fit that conventional splints simply can't match. Unlike standard splints, which come in fixed sizes and shapes, these splints are designed to perfectly conform to each individual's finger anatomy. This personalized approach could enhance comfort and effectiveness, potentially leading to better outcomes for patients. Plus, the quick production of these splints allows for rapid adjustments if needed, which is a significant advantage over the traditional method.

What evidence suggests that custom 3D-printed splints are effective for hyperextended fingers?

This trial will compare custom 3D-printed splints with conventional finger splints for treating hyperextended fingers. Research has shown that custom 3D-printed splints work well, are comfortable, and save money for conditions like hyperextended fingers and mallet finger. One study found that these splints are a cheaper and more comfortable option than traditional ones. Patients using 3D-printed splints reported greater satisfaction than those using standard splints. The custom design of 3D-printed splints provides a better fit, enhancing comfort and utility. Overall, these splints offer a promising choice for improving finger movement and patient satisfaction. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with hyperextended finger joints, which may include swan-neck deformity. It's suitable for those who can wear a finger splint for a month, whether or not they're pregnant and regardless of previous orthosis use.

Inclusion Criteria

My finger joints extend more than normal.

I have (or have not) used a finger brace for my symptoms.

I may or may not be pregnant.

Exclusion Criteria

No proximal interphalangeal joint (PIP) joint finger hyperextension

I am not fluent in English.

I am unable to make my own medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear assigned splints (either customizable 3D-printed or conventional) for 1 month

4 weeks

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for satisfaction and functional status after wearing the splints

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Finger Splints
• Custom Finger Splints

Trial Overview The study compares user satisfaction and functional status between conventional thermoplastic finger splints and customizable 3D-printed ones. Fifty participants will be assigned to one of the two groups by researchers and will use their designated splints for one month.

How Is the Trial Designed?

Group I: 3D-Printed Finger Splints Experimental Treatment 1 Intervention

Participants who wear the experimental customizable 3D-printed finger splints

Group II: Conventional Finger Splints Active Control 1 Intervention

Participants who wear the control, conventionally made finger splints

Custom Finger Splints is already approved in European Union, United States for the following indications:

Approved in European Union as Custom 3D-Printed Finger Splints for:

• Mallet finger injuries
• Hyperextended finger conditions
• Distal phalanx fractures

Approved in United States as Custom 3D-Printed Finger Splints for:

• Mallet finger injuries
• Hyperextended finger conditions
• Distal phalanx fractures

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Published Research Related to This Trial

Mallet finger deformity is a common injury that can lead to significant pain and dysfunction if not treated, with nonoperative management using splints being the primary treatment method.

The introduction of individualized 3D printed splints offers a comfortable, cost-effective, and environmentally friendly alternative to traditional splints, potentially improving patient compliance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional Printed Customized Adjustable Mallet Finger Splint: A Cheap, Effective, and Comfortable Alternative. Papavasiliou, T., Shah, RK., Chatzimichail, S., et al.[2021]

The article presents three types of finger splints—mallet finger splint, buddy splint, and dorsal finger block splint—that are designed for the conservative treatment of common hand injuries like mallet finger and ligamentous sprains.

These splints facilitate early joint movement and functional recovery by ensuring proper alignment and protection of the injured area, with detailed instructions on fabrication and usage to promote patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of simple finger injuries: the splinting regime. Chan, DY.[2019]

In a study involving 64 patients with acute type 1a or b mallet finger, no significant differences in extensor lag were found between the three splint types (Stack, dorsal, and custom thermoplastic) at 12 or 20 weeks.

However, the custom-made thermoplastic splint showed a significantly lower treatment failure rate (0%) compared to the Stack and dorsal splints (23.8% each), highlighting its potential for better patient compliance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single blind, prospective, randomized controlled trial comparing dorsal aluminum and custom thermoplastic splints to stack splint for acute mallet finger. O'Brien, LJ., Bailey, MJ.[2016]

Custom-made finger splints significantly limit joint motion in the distal and proximal interphalangeal joints compared to prefabricated splints, as shown in a study of 40 healthy individuals.

The study found that while prefabricated splints allowed for some joint movement (mean angles of 24.27° and 16.55°), custom-made splints effectively immobilized the joints (mean angles of 0.52° and 0°), indicating their superior efficacy in immobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made finger splint versus prefabricated finger splint: finger flexion stabilization. Güven, E., Suner-Keklik, S.[2022]

A custom-made thermoplastic splint was used to treat mallet finger deformity in 42 patients, showing significant effectiveness with improvement in 30 out of 34 cases assessed.

The splint was easy to create and fit for various finger shapes and sizes, and it did not cause any skin irritation, highlighting its safety and practicality for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model for the conservative management of mallet finger. Richards, SD., Kumar, G., Booth, S., et al.[2022]

A new two-part splint for treating mallet finger deformity effectively maintains the extension of the distal interphalangeal (DIP) joint while allowing flexion of the proximal interphalangeal (PIP) joint.

In a study of 25 patients, this new splint demonstrated superior treatment outcomes compared to other splinting methods, with a shorter treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pipflex splint for treatment of mallet finger. Evans, D., Weightman, B.[2022]

In a study involving 60 patients with mallet finger deformity, both the Stack splint and the custom-made aluminium alloy splint were found to be equally effective in correcting the deformity.

The aluminium alloy splint had the added benefits of being adjustable to fit a wider range of finger shapes and sizes, and it resulted in significantly fewer skin complications compared to the Stack splint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The conservative treatment of mallet finger with a simple splint: a case report. Maitra, A., Dorani, B.[2019]

In a study of 87 subjects with acute Doyle I mallet finger injuries, no significant difference in joint extension (lag difference) was found between three types of splints (custom thermoplastic, dorsal padded aluminum, and volar padded aluminum) after 12 weeks of treatment.

The results suggest that clinical measurements may overestimate the actual lag in mallet finger injuries, and that increased lag can occur after splinting is discontinued, indicating the need for careful monitoring post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinded, prospective, randomized clinical trial comparing volar, dorsal, and custom thermoplastic splinting in treatment of acute mallet finger. Pike, J., Mulpuri, K., Metzger, M., et al.[2022]

Citations

1. journals.lww.com journals.lww.com/prsgo/fulltext/2021/03000/three_dimensional_printed_customized_adjustable.42.aspx

Three-dimensional Printed Customized Adjustable Mallet... This study demonstrates our experience with the design, manufacture, and testing of individualized 3D printed mallet finger splints.

2. withpower.com withpower.com/trial/phase-hypermobility-of-interphalangeal-joints-5-2023-3e4cf

Custom 3D-Printed Splints for Hyperextended Fingers Research on 3D-printed splints for mallet finger, a similar finger condition, shows they are effective, comfortable, and cost-efficient compared to traditional ...

3. researchgate.net researchgate.net/publication/350326921_Three-dimensional_Printed_Customized_Adjustable_Mallet_Finger_Splint_A_Cheap_Effective_and_Comfortable_Alternative

Three-dimensional Printed Customized Adjustable Mallet ... To address this, we demonstrate our experience with the design, manufacture, and application of individualized 3D printed mallet finger splints.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39996536/

Customized 3-Dimensional-Printed Finger Splints for ... We aimed to evaluate the feasibility and effectiveness of customized 3-dimensional (3D)-printed finger splints in the treatment of mallet fingers.

5. accscience.com accscience.com/journal/IJB/10/4/10.36922/ijb.1963

Evaluating the clinical benefit and acceptance of a ... The results indicate that it is clinically advantageous to use a custom 3D-printed splint over a premolded generic splint.

6. researchgate.net researchgate.net/publication/340293963_Patient-specific_3D-printed_Splint_for_Mallet_Finger_Injury

(PDF) Patient-specific 3D-printed Splint for Mallet Finger ... This study explores how the use of engineering concepts such as 3D printing and topology optimization (TO) can improve outcomes for patients. 3D printing ...