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

Trial Summary

What is the purpose of this trial?

This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

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 data supports the effectiveness of the treatment Hardware removal, Hardware removal surgery, Implant removal?

Research suggests that removing hardware (like metal plates or screws) after a bone has healed can help reduce persistent pain in some patients. However, there are no clear guidelines, and the decision often depends on individual cases and surgeon experience. ^{1 2 3 4 5}

Is hardware removal surgery generally safe for humans?

Hardware removal surgery is generally considered safe, but it can carry risks of complications, especially in patients with certain conditions like liver disease or specific types of fractures. Studies show that while it is a common procedure, attention to potential complications is important, and outcomes are generally positive, especially in children. ^{2 5 6 7 8}

How does hardware removal treatment differ from other treatments for broken bones?

Hardware removal is unique because it involves surgically taking out metal implants used to fix broken bones, especially when they cause pain or complications after healing. Unlike other treatments that focus on stabilizing the bone, this procedure addresses issues related to the implants themselves, such as discomfort or infection. ^{1 2 3 4 9}

Research Team

Paul J Duffy, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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)

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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 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 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]

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]

References

1. England 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. [2019]

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

Removal of painful orthopaedic implants after fracture union. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

The Fish Hook Technique of extracting broken intramedullary nails. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Surgeons' beliefs and perceptions about removal of orthopaedic implants. [2022]

5. Netherlands 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. [2018]

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

Complications of Hardware Removal. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Metal implant removal: benefits and drawbacks--a patient survey. [2022]

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

Outcomes of Hardware Removal Surgery for Children. [2022]

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

Review of Maxillofacial Hardware Complications and Indications for Salvage. [2020]