Carbon Fiber Orthosis for Lower Limb Injury

(AFOCUFF Trial)

Overseen By Kirsten M Anderson, BSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Brain injury, Cardiac condition, Arthritis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different designs of carbon fiber braces can aid individuals with lower limb injuries. Specifically, it examines how the section of the brace that wraps around the leg below the knee affects comfort and functionality during walking. The trial targets individuals with ankle injuries, such as post-traumatic osteoarthritis, or those without lower limb pain who can walk or squat without discomfort. Participants will be divided into groups; some will test various brace designs, including the Carbon Fiber Custom Dynamic Orthosis (CDO), while others will not use a brace for comparison. As an unphased trial, this study allows participants to contribute to innovative research that could enhance brace design and comfort for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this carbon fiber orthosis is safe for lower limb injury?

Research has shown that carbon fiber is increasingly used in devices like the Carbon Fiber Custom Dynamic Orthosis (CDO) to help reduce pain. This suggests these devices are generally safe and well-tolerated. Carbon fiber's strength and light weight provide sturdy yet flexible support, aiding in walking.

Although specific safety data for the CDO is limited, similar devices using the same materials and design principles have been used safely in other orthotic applications. This offers some reassurance about the CDO's safety for people. Since the trial does not specify a phase, it might focus on different design aspects rather than just testing basic safety.

Overall, the use of proven materials and methods provides good reason to believe in the CDO's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Carbon Fiber Custom Dynamic Orthosis (CDO) for lower limb injuries because it offers a lightweight and flexible alternative to traditional rigid braces. Unlike standard options, which can be bulky and restrictive, the CDO is made from carbon fiber, providing support without sacrificing mobility. This innovative design aims to enhance comfort and recovery by allowing a more natural range of motion. The trial is exploring various versions of this orthosis, like CUFF-A, CUFF-B, CUFF-C, and CUFF-D, to assess their effectiveness in improving patient outcomes.

What evidence suggests that this orthosis is effective for lower limb injury?

This trial will evaluate different designs of custom carbon fiber orthoses for lower limb injuries. Studies have shown that custom carbon fiber braces can improve walking and movement after a leg injury. These braces store and release energy during walking, which can reduce pain and enhance leg function. Research indicates that using one of these braces reduces pressure on the front of the foot compared to walking without it, making walking more comfortable. The cuff design, which wraps around the leg, also affects the brace's comfort and effectiveness. Overall, these braces show promise in helping people with leg injuries move more easily and with less pain. Participants in this trial will be assigned to different arms, including various cuff designs (CUFF-A, CUFF-B, CUFF-C, CUFF-D) or no orthosis (NoCDO), to assess their effectiveness and comfort. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with unilateral ankle PTOA who can walk 50 feet and hop without pain, do a full squat, and don't need walking aids. They must not have severe lower extremity issues, inflammatory arthritis, recent surgeries planned on the study limb or be pregnant. A BMI over 40 or serious brain injury also disqualifies.

Inclusion Criteria

I don't have leg, back pain, open wounds, or infections right now.

I can do a full squat without feeling pain.

I have post-traumatic osteoarthritis.

Exclusion Criteria

I have been diagnosed with a moderate or severe brain injury.

I need a device like a brace for my ankle or knee to do everyday tasks.

I have had health issues or injuries that stopped me from working or exercising in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing without an orthosis and with four different proximal cuff designs

4-6 weeks

Multiple visits for testing with different orthosis designs

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Fiber Custom Dynamic Orthosis (CDO)

Trial Overview The study tests how different cuff designs of Carbon Fiber Custom Dynamic Orthoses (CDOs) affect comfort, preference, leg mechanics and loading during walking. CDOs are braces that support the leg below the knee to aid in movement for those with leg injuries.

How Is the Trial Designed?

Group I: CUFF-D Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-D

Group II: CUFF-C Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-C

Group III: CUFF-B Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-B

Group IV: CUFF-A Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-A

Group V: NoCDO Active Control 1 Intervention

Participants will be tested with no CDO

Carbon Fiber Custom Dynamic Orthosis (CDO) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in European Union as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in Canada as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Fabtech Systems

Collaborator

Trials

3

Recruited

80+

Bio-Mechanical Composites

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

A study of 131 adults using carbon fiber custom dynamic orthoses (CDOs) showed that most participants experienced significant long-term improvements in pain and physical function, with follow-up occurring an average of 4 years after intervention.

Long-term outcomes were strongly predicted by initial pain levels and short-term functional improvements, indicating that early progress with CDOs and training can lead to sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of long-term pain and function in individuals who received a custom dynamic orthosis and device-centric care pathway. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

In a study of 131 adult patients using a carbon fiber custom dynamic orthosis (CDO) combined with training, 92% reported improved physical function and 69% reported reduced maximum pain, indicating high initial effectiveness of the intervention.

The improvement in pain and physical function was significantly influenced by baseline pain levels and patient characteristics such as sex, suggesting that personalized approaches may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of a carbon fiber custom dynamic orthosis and integrated rehabilitation on self-reported physical function, pain, speed, and agility in civilians. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

A survey of 232 companies revealed that carbon fiber reinforced plastic orthoses are lightweight, well-fitted, and durable, but they are also expensive and require advanced fabrication techniques.

Health concerns were noted in manufacturing, including skin irritation and potential hazards from carbon fiber fragments, highlighting the need for improved materials and techniques to enhance safety and accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of carbon fiber reinforced plastic orthoses and occupational and medical problems based on a questionnaire administered to companies involved in the manufacture of prosthetics and orthotics]. Kaneshiro, Y., Furuta, N., Makino, K., et al.[2019]

A systematic review of 78 articles found that carbon fiber ankle-foot orthoses (AFOs) are effective in improving outcomes like walking speed, pain reduction, and balance in various patient populations, including those with lower-limb trauma and neurological disorders.

The review identified five commonly used carbon fiber AFO devices, each tailored to specific conditions, highlighting the importance of device design and patient population in achieving favorable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. Grunst, MM., Wiederien, RC., Wilken, JM.[2023]

A 72-year-old man fitted with custom carbon-fiber dynamic ankle-foot orthoses (CDOs) after bilateral transmetatarsal amputation experienced significant improvements in gait biomechanics, including over 40% increases in ankle push-off power and plantarflexor moments after just one week of use.

With additional training from a physical therapist, the patient reported enhanced mobility, confidence, and quality of life, demonstrating that CDOs can effectively support recovery and function in individuals with partial foot amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. Anderson, KM., Evans, RE., Connerly, CE., et al.[2022]

The study compared traditional ankle-foot orthoses (AFOs) with a new design featuring a dorsal carbon fiber spring in five patients with Spina Bifida, showing that the carbon spring significantly enhances energy return during walking, particularly during the push-off phase (p<0.05).

The use of carbon fiber springs resulted in more natural ankle and knee movements, suggesting improved functionality over classic AFO designs, although careful alignment during fitting is crucial for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. Wolf, SI., Alimusaj, M., Rettig, O., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38870878/

The effect of carbon fiber custom dynamic orthosis use and ... Abstract. Background: Carbon-fiber custom dynamic orthoses are used to improve gait and limb function following lower limb trauma in specialty centers. However, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05456295

Comparative Effect of Carbon Fiber Orthosis Cuff Design ... The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30334889/

Multisite Evaluation of a Custom Energy-Storing Carbon ... Background: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower- ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636224001309

Foot offloading associated with carbon fiber orthosis use Highlights. •. Compared to walking without an orthosis, peak forefoot forces decreased with carbon fiber custom dynamic orthosis use.

5. withpower.com withpower.com/trial/phase-post-traumatic-osteoarthritis-8-2022-90c84

Carbon Fiber Orthosis for Lower Limb Injury (AFOCUFF Trial) Carbon fiber orthoses, like ankle-foot orthoses (AFOs) and custom dynamic orthoses (CDOs), have been used to reduce pain and improve function in various patient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345332/

Carbon fiber ankle-foot orthoses in impaired populations Carbon fiber is increasingly being used in ankle-foot orthoses (AFOs). Orthotic devices and carbon fiber-containing devices have been shown to reduce pain ...

7. ossur.com ossur.com/en-us/bracing-and-supports/foot-and-ankle/afo-dynamic

AFO Dynamic Carbon fiber design provides excellent strength-to-weight ratio and dynamic motion. · The tapered carbon heel stores energy and manages forces at heel strike.

8. researchgate.net researchgate.net/publication/368475836_Carbon_fiber_ankle-foot_orthoses_in_impaired_populations_A_systematic_review

Carbon fiber ankle-foot orthoses in impaired populations The Intrepid Dynamic Exoskeletal Orthosis was used in individuals with lower-limb trauma, the Neuro Swing and ToeOff in individuals with ...

9. cms.gov cms.gov/medicare-coverage-database/view/article.aspx?articleId=52457

Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article This AFO is constructed of carbon fiber or equal. Included in the code are closure components and soft interface. There are no additional HCPCS codes for this ...