Subtalar Arthrodesis for Calcaneus Fractures

Recruiting at 16 trial locations

Overseen By Christine Churchill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: BMI >40, Non-English/Spanish, Prisoner, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve surgery outcomes for serious heel injuries, focusing on individuals with broken heel bones and pain from subtalar arthritis (a type of joint inflammation). The trial compares two surgical treatments: one involves fixing the bone with plates and screws, while the other combines this with joint fusion (known as Primary Subtalar Arthrodesis) to potentially reduce pain and improve long-term quality of life. Individuals with severe heel fractures and significant pain might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative surgical research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that primary subtalar arthrodesis, a procedure that fuses the joint below the ankle to treat severe heel fractures, is generally well-tolerated, though it can reduce movement in the back part of the foot. Some side effects have been reported, but they are uncommon.

The safety of the Open Reduction Internal Fixation (ORIF) method, which uses plates and screws to fix broken bones, is well-documented. This standard procedure rarely results in complications.

Both treatments have been widely used in medical settings. While each carries some risks, they are generally safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Primary Subtalar Arthrodesis (PSTA) combined with Open Reduction Internal Fixation (ORIF) because it offers a new approach to treating calcaneus fractures. Unlike the traditional ORIF, which involves using plates and screws to stabilize the broken bone, PSTA adds joint fusion to the mix. This fusion aims to provide greater stability and potentially improve healing and long-term outcomes by preventing problematic joint movement. By combining these techniques, the treatment could offer a more robust solution for patients suffering from complex heel bone fractures.

What evidence suggests that this trial's treatments could be effective for managing severe heel injuries?

Research has shown that primary subtalar arthrodesis can effectively treat severe heel fractures. In this trial, some participants will undergo this surgery, which fuses the joint to stop movement and reduce pain, potentially leading to better long-term results. This procedure often eliminates the need for additional surgeries and reduces post-surgical pain related to subtalar arthritis. One study found that patients experienced improved mobility and function, as measured by a specific foot and ankle scale. This suggests that primary subtalar arthrodesis can enhance the quality of life for those with serious heel fractures. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph R Hsu, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe heel bone fractures (Sanders III/IV or Sanders II with specific complications). Participants must be undergoing surgery, able to attend follow-ups for a year, and speak English or Spanish. It's not for those using certain surgical methods, under 18, very overweight (BMI >40), unable to commit to follow-up visits, or prisoners.

Inclusion Criteria

Able to follow up at site for 1 year

I am having surgery for a broken heel bone that affects the joint.

I have a severe heel bone fracture with specific complications.

Exclusion Criteria

My heel bone is fractured but doesn't have severe complications.

Body Mass Index (BMI) >40

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical treatment with either ORIF + PSTA or ORIF alone

6 weeks

Multiple visits for surgical procedure and initial recovery

Follow-up

Participants are monitored for safety, effectiveness, and recovery progress

12 months

Regular follow-up visits at Week 6, Months 3, 6, and 12

Outcome Assessment

Assessment of primary and secondary outcomes including return to work, pain levels, and functional recovery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Primary Subtalar Arthrodesis

Trial Overview The study compares two surgical treatments for serious heel injuries: one group receives both an open reduction internal fixation (ORIF) and primary subtalar arthrodesis (PSTA), while the other gets only ORIF. The goal is to see which method better reduces long-term pain and improves quality of life.

How Is the Trial Designed?

Group I: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) Experimental Treatment 1 Intervention

Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Group II: Open Reduction Internal Fixation (ORIF) only Experimental Treatment 1 Intervention

Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Subtalar arthrodesis was performed on 13 patients (15 feet) with a mean follow-up of 24.9 months, showing an 85% satisfaction rate among patients, with 73% achieving excellent results.

The procedure had no cases of nonunion, although complications included one superficial wound infection and one case of staple loosening, suggesting that while effective, the fixation method may need improvement to enhance fusion time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtalar arthrodesis for subtalar arthritis. Huang, PJ., Chen, SK., Chen, YW., et al.[2015]

Arthroscopic subtalar arthrodesis significantly improved patient outcomes for posttraumatic arthritis following calcaneal fractures, with average AOFAS scores rising from 49.0 to 76.0 points over an average follow-up of 57.5 months.

The procedure had a union rate comparable to open arthrodesis, although a higher incidence of nonunion was noted in patients with prior internal fixation, highlighting the importance of surgical history in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic posterior subtalar arthrodesis for salvage of posttraumatic arthritis following calcaneal fractures. Vilá-Rico, J., Ojeda-Thies, C., Mellado-Romero, MÁ., et al.[2019]

Patients who underwent initial open reduction and internal fixation (Group A) for displaced intra-articular calcaneal fractures had significantly better functional outcomes compared to those who received nonoperative treatment (Group B), as evidenced by higher Maryland Foot Scores (90.8 vs. 79.1) and American Orthopaedic Foot and Ankle Society scores (87.1 vs. 73.8).

Group A also experienced fewer postoperative wound complications, suggesting that initial surgical intervention not only improves functional results but may also enhance safety during subsequent subtalar fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtalar fusion after displaced intra-articular calcaneal fractures: does initial operative treatment matter? Radnay, CS., Clare, MP., Sanders, RW.[2016]

In a study of 16 patients who underwent primary subtalar arthrodesis for severely comminuted calcaneal fractures, all patients showed successful bony bridging within 8 to 12 weeks post-surgery, indicating effective healing.

The procedure allowed 11 out of 12 patients who were employed before their injury to return to work, with a mean clinical rating score of 72.4 out of 100, suggesting good functional outcomes after an average follow-up of 26 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Buch, BD., Myerson, MS., Miller, SD.[2017]

In a study of 48 isolated subtalar arthrodeses involving 44 patients over an average follow-up of 59.5 months, 93% reported satisfaction with their treatment, indicating a high level of efficacy for this surgical intervention.

While pain and function improved significantly, there was a notable reduction in joint motion (40% in transverse tarsal motion and 30% in dorsiflexion), and some patients experienced mild radiographic progression of arthrosis in adjacent joints, suggesting careful patient selection is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated subtalar arthrodesis. Mann, RA., Beaman, DN., Horton, GA.[2022]

Patients who underwent initial open reduction and internal fixation (Group A) for displaced intra-articular calcaneal fractures had significantly better functional outcomes compared to those who received nonoperative treatment (Group B), as evidenced by higher Maryland Foot Scores (90.8 vs. 79.1) and American Orthopaedic Foot and Ankle Society scores (87.1 vs. 73.8).

Group A also experienced fewer postoperative wound complications, suggesting that initial surgical intervention not only improves functional results but may also enhance safety during subsequent subtalar fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtalar fusion after displaced intra-articular calcaneal fractures: does initial operative treatment matter? Surgical technique. Radnay, CS., Clare, MP., Sanders, RW.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11206830/

Primary subtalar arthrodesis of calcaneal fractures We evaluated retrospectively the long-term results of isolated calcaneal fractures treated with open reduction and internal fixation and a primary subtalar ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05504304

NCT05504304 | Primary Subtalar Arthrodesis Versus Late ... 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes. When the talus applies ...

3. trialx.com trialx.com/clinical-trials/listings/297647/primary-subtalar-arthrodesis-for-calcaneal-fractures/

Primary Subtalar Arthrodesis for Calcaneal Fractures The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work ...

4. link.springer.com link.springer.com/article/10.1007/s12306-025-00901-0

Primary subtalar arthrodesis in displaced intra-articular ... Primary arthrodesis of the subtalar joint for treating DIACFs, mostly Sanders type IV, provides good results due to the avoidance of further procedures.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251614003457

Primary Subtalar Joint Arthrodesis for Comminuted ... The American Orthopaedic Foot and Ankle Society Ankle-Hindfoot scale score was obtained at an average of 34 (range 12 to 157) months after arthrodesis.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138317305478

Outcome following osteosynthesis or primary arthrodesis of ... However, as the subtalar joint is fused it may lead to decreased hindfoot function. The aim of this study was to compare the mid-term functional outcome of ...

7. withpower.com withpower.com/trial/phase-fractures-bone-4-2024-0257a

Subtalar Arthrodesis for Calcaneus Fractures Primary subtalar arthrodesis is unique because it involves fusing the subtalar joint (the joint below the ankle) to treat severe calcaneus (heel bone) fractures ...