Custom 3D-Printed Splints for Hyperextended Fingers

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Endeavor Health

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.

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 data supports the effectiveness of 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 splints. They provide similar benefits to thermoplastic splints but with added comfort and reduced skin issues, which can improve patient compliance and outcomes. ^{1 2 3 4 5}

Is it safe to use custom 3D-printed splints for hyperextended fingers?

Research on custom 3D-printed splints, particularly for mallet finger injuries, suggests they are generally safe, with no reported skin irritation or complications, and they offer comfort similar to traditional splints. ^{1 2 4 6 7}

How is the treatment of custom 3D-printed splints for hyperextended fingers different from other treatments?

Custom 3D-printed splints for hyperextended fingers are unique because they are individually designed to fit each patient's finger, offering a comfortable and effective alternative to traditional splints. They are low-cost, easy to manufacture, and environmentally friendly, addressing common issues like discomfort and skin complications associated with prefabricated splints. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Conventional Finger Splints (Other)
• Custom Finger Splints (Other)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Gerald "J.P." Gallagher

Endeavor Health

Chief Executive Officer since 2022

MBA from Benedictine University

Sanjeeb Khatua, MD

Endeavor Health

Chief Physician Executive since 2023

MD from Rush Medical College

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

David Hall

NorthShore University HealthSystem

Chief Executive Officer since 2009

MBA in Healthcare Management, Western Governors University

Dr. Andi Arnautovic

NorthShore University HealthSystem

Chief Medical Officer since 1989

Residency at Mount Sinai Hospital, Chicago

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

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

Three-dimensional Printed Customized Adjustable Mallet Finger Splint: A Cheap, Effective, and Comfortable Alternative. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Custom-made finger splint versus prefabricated finger splint: finger flexion stabilization. [2022]

3. United States 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. [2016]

4. Scotland pubmed.ncbi.nlm.nih.gov

A model for the conservative management of mallet finger. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

The Pipflex splint for treatment of mallet finger. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

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

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

Blinded, prospective, randomized clinical trial comparing volar, dorsal, and custom thermoplastic splinting in treatment of acute mallet finger. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The conservative treatment of mallet finger with a simple splint: a case report. [2019]