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

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.

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 data supports the effectiveness of the treatment Pre-Fabricated Fracture Brace, Webril Padded Plaster Splint, Webril Padded Plaster Splint, Coaptation Splint for broken arms?

A study found that a prefabricated brace provided higher pressure at the fracture site compared to a traditional plaster cast, which may suggest better support for healing. Additionally, another study indicated that both splints and casts effectively maintain fracture alignment, with a slight cost advantage for initial cast placement. ^{1 2 3 4 5}

How does the treatment of bracing vs splinting for a broken arm differ from other treatments?

The treatment using a Pre-Fabricated Fracture Brace or Webril Padded Plaster Splint allows for early movement of joints and muscles, which can eliminate the need for rehabilitation after removal, unlike traditional plaster casts that fully immobilize the limb. ^{6 7 8 9 10}

Research Team

Abhishek Ganta, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Refracture Rate of Both Bone Forearm Fractures: A Retrospective Comparison of Casting Alone Versus Casting and Extended Functional Bracing. [2021]

2. United States 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. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Is softcast (3M) strong enough for potentially unstable paediatric forearm fractures? [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Intracast pressure measurements in Colles' fractures. [2019]

5. United States 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? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Own clinical experience with functional bracing for treatment of pseudarthrosis and delayed union of the tibia. [2016]

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

Braces and splints for musculoskeletal conditions. [2007]

9. Germany pubmed.ncbi.nlm.nih.gov

[Functional bracing of fractures]. [2006]

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

A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. [2022]