Subtalar Arthrodesis for Calcaneus Fractures

Recruiting at 15 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

Trial Summary

What is the purpose of this trial?

Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Subtalar Arthrodesis for Calcaneus Fractures?

Research shows that primary subtalar arthrodesis can be effective for treating severe calcaneus fractures, with most patients achieving bone healing within 8 to 12 weeks and many returning to work. Additionally, subtalar arthrodesis has been successful in improving pain and function in patients with subtalar arthritis, with a high satisfaction rate among patients. ^{1 2 3 4 5}

How is primary subtalar arthrodesis different from other treatments 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, restoring bone height and width with bone grafts and screws. This approach is particularly beneficial for patients with complex fractures, allowing many to return to work and daily activities, unlike other treatments that may not address severe cases as effectively. ^{1 2 3 4 6}

Research Team

Joseph R Hsu, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

I am under 18 years old.

Body Mass Index (BMI) >40

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. [2017]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Subtalar arthrodesis for subtalar arthritis. [2015]

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

Subtalar fusion after displaced intra-articular calcaneal fractures: does initial operative treatment matter? Surgical technique. [2016]

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

Subtalar fusion after displaced intra-articular calcaneal fractures: does initial operative treatment matter? [2016]

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

Isolated subtalar arthrodesis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic posterior subtalar arthrodesis for salvage of posttraumatic arthritis following calcaneal fractures. [2019]