Bracing vs Splinting for Broken Arm

Recruiting at 2 trial locations

Overseen By Abhishek Ganta, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Open fractures, Poly trauma, Malignancy, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best method to immobilize broken upper arm bones (humeral shaft fractures) in the emergency room. It compares a Sarmiento brace (a pre-fabricated fracture brace) with a coaptation splint (a Webril padded plaster splint). The trial aims to determine which method provides more comfort by tracking pain, use of painkillers, and arm function over two weeks. Individuals who have recently broken their upper arm and are receiving non-surgical treatment may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to improving emergency care practices 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. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these immobilization methods are safe for treating humeral shaft fractures?

Research shows that Sarmiento bracing, a type of ready-made brace for fractures, is generally easy for patients to use. In several studies, patients using this brace experienced little pain and maintained good arm mobility. Most patients experienced bone healing and reported being mostly pain-free.

Evidence suggests that the Webril Padded Plaster Splint is a safe option for temporary support, especially when swelling and bleeding occur. Splints allow some movement, which can help prevent stiffness.

Overall, both the Sarmiento brace and the Webril padded splint are considered safe for treating upper arm fractures. However, comfort and effectiveness can vary. Consulting a healthcare provider is important to determine the best option for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches for managing broken arms: the Sarmiento Brace and the Coaptation Splint. The Sarmiento Brace is unique as it allows for some movement, which can aid muscle activity and circulation, potentially speeding up recovery. On the other hand, the Coaptation Splint is a padded plaster splint which offers robust support, providing stability and comfort as the fracture heals. This trial aims to determine which method offers better outcomes in terms of healing time, comfort, and overall effectiveness compared to traditional plaster casts.

What evidence suggests that this trial's methods of immobilization could be effective for humeral shaft fractures?

This trial will compare the effectiveness of two treatments for broken arms: the Sarmiento brace and the Webril padded plaster splint. Research has shown that the Sarmiento brace, a ready-made brace for broken bones, effectively heals breaks in the upper arm bone. In one study, most participants using this brace experienced bone healing, felt little pain, and maintained most of their arm function. This brace also allows free movement of the shoulder and elbow, improving comfort and mobility.

Alternatively, the Webril padded plaster splint is another option in this trial for immobilizing broken bones. Although specific data on its effectiveness for upper arm fractures is limited, splints generally allow early joint movement and can help reduce pressure, potentially enhancing comfort. Both methods aim to stabilize the fracture while permitting some movement to speed up recovery. ^{1 2 4 5 6}

Who Is on the Research Team?

Abhishek Ganta, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a fresh break in the upper arm bone, who are being treated without surgery. It's not for those with cancer treatments, open fractures, multiple injuries at once, or prisoners.

Inclusion Criteria

I received non-surgical treatment for the first 2 weeks.

I am over 18 years old and my bones have stopped growing.

Isolated Injury

Exclusion Criteria

Poly trauma

Prisoners

I am currently receiving treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either sarmiento bracing or coaptation splinting for humeral shaft fractures

2 weeks

Initial visit in the emergency room

Follow-up

Participants are monitored for pain, narcotic usage, and function to determine preferred immobilization method

2 weeks

1 follow-up visit at week 2

What Are the Treatments Tested in This Trial?

Interventions

• Pre-Fabricated Fracture Brace
• Webril Padded Plaster Splint

Trial Overview

The study compares two ways to keep the broken arm still right after injury: using a ready-made brace versus a padded plaster splint. Comfort, pain levels, need for painkillers and how well patients can use their arms will be checked over two weeks.

How Is the Trial Designed?

Group I: Sarmiento Brace Active Control 1 Intervention

Group II: Coaptation Splint Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 243 patients with displaced Colles' fractures, different immobilization methods (conventional plaster, above-elbow cast-brace, and below-elbow cast-brace) did not significantly affect the anatomical or functional outcomes after treatment.

The results indicated that early hand function and the supinated position did not provide any advantages over traditional plaster casts, suggesting that conventional plaster remains a suitable treatment for uncomplicated Colles' fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. Stewart, HD., Innes, AR., Burke, FD.[2022]

In a study involving 113 children aged 6 to 15 with wrist buckle fractures, those treated with a removable splint showed significantly better physical functioning compared to those in a short arm cast, particularly noted at 14 days post-injury.

Both treatment groups reported similar levels of pain and had no cases of refractures, suggesting that splinting is a safe and effective alternative to casting for this type of injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Plint, AC., Perry, JJ., Correll, R., et al.[2022]

In a study involving 100 pediatric patients with upper extremity fractures, the customized 'Providence' Pedi Cast-Sling (PPCS) significantly improved patient and parent satisfaction compared to a standard sling, with higher convenience and compliance reported.

Patients using the PPCS wore the sling for an average of 10.3 hours a day, compared to only 5.9 hours for those with the standard sling, indicating that the PPCS encourages better adherence to immobilization after casting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. Cruz, AI., DeFroda, SF., Gil, JA., et al.[2019]

Functional bracing using individually produced 'combicast' braces effectively promotes healing in tibial fractures, with 34 out of 35 patients achieving bone consolidation within 4 to 12 months, demonstrating its efficacy even in cases of delayed union.

The method is safe, with no complications reported, and it also enhances patient comfort and reduces the need for extensive rehabilitation, making it a valuable treatment option for both acute and complicated tibial fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Own clinical experience with functional bracing for treatment of pseudarthrosis and delayed union of the tibia. Bara, T., Sibiński, M., Synder, M.[2016]

Fracture bracing is an effective nonoperative treatment for humerus, ulna, and stable tibia fractures, allowing for early movement and muscle activation, which aids in healing without the need for rehabilitation after brace removal.

In a study of 84 humerus fractures, 82 healed within 6-8 weeks with excellent functional and cosmetic results, while 48 ulna fractures showed 47 heal within 6 weeks, indicating high efficacy of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional bracing of fractures]. Hackstock, H.[2006]

Unloader (valgus) knee braces are effective for reducing pain in patients with osteoarthritis in the medial compartment of the knee, supported by good evidence.

Functional ankle braces are preferred over immobilization for treating acute ankle sprains and can help prevent future sprains, while a neutral wrist splint can improve symptoms of carpal tunnel syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braces and splints for musculoskeletal conditions. Gravlee, JR., Van Durme, DJ.[2007]

In a study of 426 children with midshaft forearm fractures, prolonged functional bracing after cast immobilization did not significantly reduce the rate of refracture compared to casting alone or short-term bracing.

The refracture rates were 2.7% for casting only, 5% for short-term bracing, and 1.8% for prolonged bracing, indicating that the benefits of extended bracing may be minimal and highlighting the need for larger studies to explore effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refracture Rate of Both Bone Forearm Fractures: A Retrospective Comparison of Casting Alone Versus Casting and Extended Functional Bracing. Soumekh, L., Sylvanus, T., Karlen, A., et al.[2021]

A 6-wrap Softcast splint provides sufficient mechanical stability for treating unstable paediatric forearm fractures, with load capacities that exceed the forces exerted by body weight in many children.

Softcast splints are lighter, more comfortable, and can be easily removed compared to traditional plaster of Paris, making them a preferable option for younger patients while potentially reducing hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is softcast (3M) strong enough for potentially unstable paediatric forearm fractures? Patel, N., Wilson, L., Wansbrough, G.[2017]

The new prefabricated brace for treating Colles' fractures showed consistently higher interface pressures compared to traditional plaster casts, indicating better support and stability.

The brace applied more targeted loading to the fracture site, which may enhance healing and functional recovery during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracast pressure measurements in Colles' fractures. Moir, JS., Wytch, R., Ashcroft, GP., et al.[2019]

In a study of pediatric patients aged 5 to 14 with distal radius or both-bone forearm fractures, both splint and cast immobilization methods effectively maintained fracture alignment in 94% of cases after reduction.

While a sugar-tong splint showed slightly better alignment maintenance, the difference was not statistically significant, and the initial placement of a short-arm cast was found to be more cost-effective at $23.59 compared to $26.95 for a splint followed by a cast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis and performance in distal pediatric forearm fractures: is a short-arm cast superior to a sugar-tong splint? Acree, JS., Schlechter, J., Buzin, S.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/11988725/

The results of functional (Sarmiento) bracing of humeral ...

At the Department of Orthopaedics of the Kantonsspital Fribourg, 67 humeral shaft fractures were treated by Sarmiento bracing in a 15-year period.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05118087

Comparison of Bracing With Co-aptation Splinting for the ...

The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7218498/

Effect of Surgery vs Functional Bracing on ...

Internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months.

4.

openorthopaedicsjournal.com

openorthopaedicsjournal.com/VOLUME/13/PAGE/136/

Evaluating the Outcome of a New Functional Brace ...

Our new functional brace led to bony union in most patients, and from a clinical perspective, most patients were pain free and had minimal loss of function.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878124122000375

Exploring patient experiences after treatment of humeral ...

Functional braces enable free movement of the shoulder and elbow joint and should be adjusted frequently to maintain adequate compression around the upper arm.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5883908/

Best care paradigm to optimize functionality after extra- ...

Originally described by Sarmiento, functional bracing has been shown to have a significant role in the treatment of humeral fractures for the general population ...