Fixation vs. Removal for Broken Bones

(FIRM Trial)

Recruiting at 2 trial locations

Overseen By Karin Lienhard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Significant foot injury, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 months

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether keeping or removing hardware (surgical screws or plates) used to fix a Lisfranc injury, a type of foot injury affecting the arch, leads to better recovery and fewer complications. Participants will either keep the hardware in place or undergo hardware removal surgery six months after their initial surgery. This trial suits individuals who had a Lisfranc injury treated within the last few weeks and are prepared to adhere to the follow-up schedule. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance future treatment options for Lisfranc injuries.

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.

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

Research has shown that removing metal plates or screws after a bone fracture heals is generally safe. One study found that this procedure carries minimal risk, with most individuals experiencing less pain and improved mobility afterward.

Another study discovered that removing these implants is quite common, with nearly 81% eventually taken out. Some individuals report issues like scars or lingering symptoms, but no major negative effects, such as harmful metal levels affecting health, have been observed.

Overall, hardware removal is usually well-tolerated and can enhance comfort and movement after a fracture has healed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach of retaining hardware in broken bones, the focus here is on the removal of hardware at six months. This method could potentially reduce long-term risks like infection and discomfort associated with leaving hardware in the body. Researchers are excited about this trial because it may offer a more comfortable and safer alternative for patients, ultimately improving recovery experiences and outcomes.

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

Research has shown that removing metal plates or screws after a bone fracture can lead to good results. In this trial, participants will either retain their hardware or have it removed. One study found that 72% of patients moved better, and 96% felt less pain after hardware removal. Another study confirmed that removing these implants after the bone heals can safely ease symptoms. However, some patients might experience short-term issues after the procedure. Overall, removing hardware has effectively reduced pain and improved movement for many patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul J Duffy, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals who have had a Lisfranc injury (midfoot dislocation/fracture) treated within the past 28 days and are between 6 to 8 weeks post-initial fixation surgery. They must be medically fit, able to follow the study protocol, and not have significant pre-existing foot conditions or injuries that could affect recovery.

Inclusion Criteria

Subject is willing and able to comply with the study protocol including return for all follow-up evaluations

Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon

Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria

Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)

Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires

Subject is pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6-8 weeks

Treatment

Participants undergo either hardware removal or retention after open reduction and internal fixation of Lisfranc injuries

6 months

1 visit (in-person) at 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at multiple time points

2 years

Visits at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Hardware removal

Trial Overview The study compares two approaches after initial surgical treatment of Lisfranc injuries: keeping the hardware in place (HR) versus removing it (RH). It's a multicenter trial where participants will be randomly assigned to one of these two options.

How Is the Trial Designed?

Group I: Hardware Removal Experimental Treatment 1 Intervention

Removal of hardware at 6 months.

Group II: Hardware Retention Active Control 1 Intervention

Retention of hardware at 6 months

Hardware removal is already approved in United States, European Union for the following indications:

Approved in United States as Hardware removal for:

• Pain from hardware
• Infection
• Allergic reaction to hardware
• Nerve damage
• Broken hardware
• Bones that did not heal and join properly

Approved in European Union as Hardware removal for:

• Pain from hardware
• Infection
• Allergic reaction to hardware
• Nerve damage
• Broken hardware
• Bones that did not heal and join properly

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

Calgary Orthopaedic Research and Education Fund

Collaborator

Trials

4

Recruited

530+

Published Research Related to This Trial

A survey of 655 surgeons from 65 countries revealed that 58% do not believe routine removal of orthopedic implants is necessary, and many do not see significant risks associated with leaving implants in place.

Surgeons rated the effectiveness of implant removal in symptomatic patients as moderate, indicating a need for further research to evaluate the true benefits and risks of this common procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgeons' beliefs and perceptions about removal of orthopaedic implants. Hanson, B., van der Werken, C., Stengel, D.[2022]

In a survey of 332 patients who underwent hardware removal, 72% reported improved function and 96% reported decreased pain after the procedure, indicating high efficacy of implant removal for addressing pain and functional impairment.

Despite a 10% complication rate, 96% of patients would choose to have the surgery again, suggesting strong overall satisfaction with the outcomes of hardware removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal implant removal: benefits and drawbacks--a patient survey. Reith, G., Schmitz-Greven, V., Hensel, KO., et al.[2022]

A review of 15 studies involving over 2,900 patients with facial fractures revealed that 50% of complications related to maxillofacial hardware required removal, particularly in cases of loosening, nonunion, broken hardware, and severe pain.

Some complications, such as exposure, deformities, and infections, can potentially be managed through salvage techniques rather than removal, highlighting the need for better-defined guidelines and the establishment of a national databank for improved clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Maxillofacial Hardware Complications and Indications for Salvage. Hernandez Rosa, J., Villanueva, NL., Sanati-Mehrizy, P., et al.[2020]

In a review of 13,089 hardware removal procedures performed by recently trained orthopedic surgeons, there was an overall complication rate of 9.6%, highlighting the risks associated with this common surgery.

The most frequent complications included wound-healing delays (2.1%) and infections (1.6%), but serious complications like nerve injury (0.6%) and life-threatening events (0.4%) were also reported, indicating that while hardware removal can improve function, it carries significant risks that both surgeons and patients should consider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Hardware Removal. Kellam, PJ., Harrast, J., Weinberg, M., et al.[2021]

In a study of 60 patients with persistent pain from fracture fixation hardware, the removal of the implants was found to be safe, with no complications reported during the surgery.

At one year post-surgery, patients experienced a significant reduction in pain (76% improvement) and improved function, with over half reporting complete resolution of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Removal of painful orthopaedic implants after fracture union. Minkowitz, RB., Bhadsavle, S., Walsh, M., et al.[2022]

A study of 227 pediatric patients undergoing deep hardware removal showed that the procedure is safe, with only 3 reported complications, and has excellent outcomes over a mean follow-up of 25 months.

The study suggests that having a more senior resident perform the surgery can help minimize complications, indicating that experience plays a crucial role in the safety of hardware removal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Hardware Removal Surgery for Children. Ryan, C., Dunleavy, ML., Burton, A., et al.[2022]

The study presents a new technique for safely removing the distal portion of broken intramedullary nails in orthopedic surgery, which is particularly useful in cases of delayed union or non-union.

This innovative method minimizes additional trauma during the removal process and can be applied to various types of hollow intramedullary nails, enhancing the efficiency of revision surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fish Hook Technique of extracting broken intramedullary nails. Acharya, M., Alani, A., Almedghio, S.[2008]

This systematic review aims to evaluate the effectiveness of removing internal fixation hardware in patients experiencing pain after ankle fracture healing, addressing a common clinical dilemma without existing evidence-based guidelines.

The review will include studies published since 1967, focusing on both randomized controlled trials and non-RCTs, and will assess the quality of evidence to provide clearer insights into whether hardware removal alleviates post-surgical discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle: a systematic review protocol. Thune, A., Hagelberg, M., Nåsell, H., et al.[2019]

In a study of 391 patients undergoing elective removal of orthopedic hardware after fracture fixation, the overall complication rate was found to be 8.4%, with a 3.6% rate of requiring revision surgery.

Patients with liver disease were identified as having a significantly higher risk for complications and revision surgery, while those having hardware removed from pilon fractures faced increased complication risks, and pelvic hardware removal was linked to a higher likelihood of needing additional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased risk for complications following removal of hardware in patients with liver disease, pilon or pelvic fractures: A regression analysis. Brown, BD., Steinert, JN., Stelzer, JW., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12283862/

Implant removal: benefits and drawbacks Reith et al., after hardware removal, reported an improvement in function of 72% and decreased pain in 96% of patients who responded to the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5327671/

Indications of implant removal: A study of 83 cases Twenty-four patients out of 83 (28.91%) needed hardware removal because they had developed infection at the implant site a variable duration after ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138317306459

Increased risk for complications following removal of ... The purpose of this study is to determine the overall short-term complication rate for elective removal of orthopedic hardware after fracture fixation and to ...

4. morthoj.org morthoj.org/2022/v16n3/elective-removal-healing.pdf

Is Elective Implant Removal after Fracture Healing ... Conclusions: Implant removal after uneventful healing of extremity fractures is a safe procedure that conferred a predictable relief of symptoms and ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/7/8/e014560

The benefits of hardware removal in patients with pain or ... We hope to provide evidence-based data on outcome following hardware removal from the ankle after fracture healing in adults. Studies published in other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4528685/

Metal implant removal: benefits and drawbacks – a patient ... In 332 patients surveyed, most hardware removals were performed at the ankle joint (21 %) followed by the wrist (15 %). The most frequent ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138318303115

Benefits of hardware removal after plating In a Finnish study, nearly all (81%) implants inserted for fracture fixation were eventually removed [11]. In total, implant removal contributed to almost 30% ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17768185/

Removal of painful orthopaedic implants after fracture union Conclusions: Following fracture-healing, removal of hardware is safe with minimal risk. Improvement in pain relief and function can be expected.

9. link.springer.com link.springer.com/article/10.1007/s00264-025-06564-7

Implant removal: benefits and drawbacks - Results of a ... Regarding postoperative outcomes, the most frequently reported issues included unpleasant scars (35.4%), persistence of symptoms (31.4%), and ...

10. journals.lww.com journals.lww.com/jaaosglobal/fulltext/2022/04000/indications_for_and_risks_associated_with_implant.16.aspx

Indications for and Risks Associated With Implant Removal... Abnormal levels of metal ions in patients with spinal implants have been reported; however, there were not any accompanying adverse clinical effects.