Conservative or Surgical Treatment for Hammer Toe

Overseen By Hafizur Rahman, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Rio Grande Valley

Disqualifiers: Peripheral vascular disease, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how hammertoe affects foot pressure and whether correcting it can improve quality of life. Participants will receive either conservative treatment, such as special shoes or exercises, or undergo surgery. Suitable candidates for this trial have a confirmed hammertoe deformity and experience issues like claw or hammer toe. As an unphased trial, this study provides a unique opportunity to contribute to the understanding and improvement of hammertoe treatments.

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 coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hammertoe surgery is generally safe, though complications can occur. Studies indicate that about 10.3% to 13.5% of patients experience issues after surgery, such as the unexpected removal of surgical hardware. However, these complications are considered rare.

Non-surgical treatments for hammertoe, such as wearing special shoes or engaging in physical therapy, avoid surgical risks. However, less information is available about their safety compared to surgery.

For both options, considering overall health and consulting with a doctor is crucial to determine the best choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for hammer toe because they explore both conservative and surgical options to address the condition. Unlike typical conservative treatments, which may involve orthotics or splints to alleviate discomfort, the investigational conservative approach could offer new techniques or materials that enhance comfort and effectiveness. On the surgical side, while traditional surgery often involves joint resection or fusion, this study might be testing a novel surgical method that aims to improve outcomes or reduce recovery time. By comparing these innovative approaches, researchers hope to discover more effective or patient-friendly solutions for managing hammer toe.

What evidence suggests that this trial's treatments could be effective for hammertoe?

This trial will compare Conservative Treatment with Surgical Treatment for hammer toe. Research has shown that changing shoes and using custom shoe inserts, which participants in the Conservative Treatment arm may receive, can relieve hammertoe symptoms. This non-surgical method can reduce discomfort and improve foot function for many people. In the Surgical Treatment arm, participants may undergo surgery to correct hammertoe, which studies have found can significantly reduce pain. Many patients report satisfaction after surgery, experiencing less pain and few complications. Both treatments are viable options, depending on the severity of the condition and individual needs. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with hammertoe deformities, specifically claw or hammer toe, who also have sensory neuropathy and a certain type of toe joint extension. People can't join if they have conditions like Morton's neuroma, other foot deformities not related to hammertoes, severe vascular diseases, non-diabetic nerve issues, major musculoskeletal problems in the lower limbs, rheumatoid arthritis, current foot ulcers or swelling, inability to walk without help or past foot surgeries.

Inclusion Criteria

Claw or hammer toe deformity in toes

I have been diagnosed with nerve damage in my hands and feet.

I have a bending backward deformity in my toe joint.

Exclusion Criteria

MRI contraindications

I have Morton's neuroma.

I have foot deformities not related to hammertoes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants undergo initial data collection session before the intervention begins

1 visit

1 visit (in-person)

Intervention

Participants receive either conservative or surgical treatment for hammertoe deformities

3 months

Post-intervention

Participants undergo a follow-up data collection session three months after the intervention

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conservative
• Surgical

Trial Overview The study is examining two types of treatments for hammertoe: conservative methods (like special footwear) versus surgical intervention. It aims to see how these treatments affect the way pressure is distributed across the foot when walking and overall quality of life.

How Is the Trial Designed?

Group I: Surgical Treatment Experimental Treatment 1 Intervention

Group II: Conservative Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559268/

Hammertoe - StatPearls - NCBI Bookshelf - NIH This procedure is therefore most effective in treating flexor induced hammertoe deformities that are semirigid or rigid, as well as for elongated digits. Due ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1268773110001141

Prospective review of medium term outcomes following ... Overall we demonstrate good to excellent results with this surgical tactic allowing pain relief, early mobilisation and a low risk of infection. Introduction.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8702909/

Comorbidities Associated With Poor Outcomes Following ... The current study demonstrated that hammertoe correction surgery results in an overall improvement in patient-reported pain levels (VAS 4.0 ± 2.8 decreased to ...

4. aetna.com aetna.com/cpb/medical/data/600_699/0636.html

Hammertoe Repair - Medical Clinical Policy Bulletins The authors concluded that percutaneous K-wire fixation remains a reliable and cost-effective method of stabilization during hammertoe correction in comparison ...

5. researchgate.net researchgate.net/publication/385570125_The_effectiveness_of_shoe_modifications_and_foot_orthoses_in_conservative_treatment_of_lesser_toe_deformities_a_review_of_literature

The effectiveness of shoe modifications and foot orthoses ... Among conservative treatments, shoe modifications and the application of orthoses may, in most cases, alleviate symptoms. From a careful analysis of the ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251623002478

Minimally Invasive Versus Open Hammertoe Correction In the MIS group 5 hammertoes had unplanned hardware removal (4.03%) compared to 0 in the open group. There was no statistical significance for both recurrence ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29444584/

Complication Rates and Short-Term Outcomes After ... Complications occurred in 13.5% and 10.3% of patients in the younger and older cohorts, respectively. Conclusions: Outcomes of operative correction of hammertoe ...

8. journals.lww.com journals.lww.com/atmr/fulltext/2025/04000/outcomes_of_minimally_invasive_surgery_versus.18.aspx

Outcomes of Minimally Invasive Surgery versus Traditional... Patients with hallux valgus with hammer toes have limited mobility and quality of life. In Saudi Arabia, 21% of individuals have hallux valgus, ...