Surgical Treatments for Ankle Arthritis

Overseen By Trish Francis, R N

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ross Leighton

Disqualifiers: Dead bone, Severe deformity, Prior fusion, Infection, Obesity, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure with immediate post-operative care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical treatments for ankle arthritis: Total Ankle Arthroplasty and Ankle Arthrodesis. Researchers aim to determine if Total Ankle Arthroplasty has a similar success rate to Ankle Arthrodesis over 10 years and if it results in fewer complications. Individuals with ankle arthritis for more than six months, who have tried other treatments without improvement, and who experience severe symptoms may be suitable candidates. Participants will help identify which surgery provides better long-term outcomes and fewer additional issues. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance surgical options for future patients.

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 both Total Ankle Replacement and Ankle Fusion safely treat ankle arthritis. Studies have found these procedures effective with a low risk of complications. For example, both treatments have proven successful for up to 8 years in individuals with severe ankle arthritis.

When comparing the two, Total Ankle Replacement typically results in fewer infections and amputations than Ankle Fusion. However, it may have a higher likelihood of requiring additional surgery later. Overall, both treatments are well-tolerated and maintain a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ankle arthritis because they offer surgical solutions that can significantly improve mobility and reduce pain. Ankle Arthrodesis, commonly known as ankle fusion, involves fusing the bones of the ankle joint to eliminate motion and provide pain relief. This procedure is effective for severe arthritis but can limit mobility. On the other hand, Total Ankle Arthroplasty, or ankle replacement, aims to preserve joint movement by replacing the damaged joint with an artificial implant. This option is particularly appealing as it can maintain more natural movement and potentially improve patients' quality of life compared to traditional fusion methods.

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

This trial will compare two surgical treatments for severe ankle arthritis: Total Ankle Arthroplasty and Ankle Arthrodesis. Research has shown that both Total Ankle Replacement, which participants in this trial may receive, and Ankle Fusion, another treatment option in this trial, are effective. Studies have found that Total Ankle Replacement often leads to better outcomes than fusion surgery, with improvements noted after two years, showing good to excellent results in reducing pain and improving function. Ankle Fusion also provides significant pain relief and better function over time. Both treatments offer similar benefits up to eight years after the procedure, but Total Ankle Replacement might cause fewer issues with nearby joints later on. ^{2 6 7 8 9}

Who Is on the Research Team?

Tim Daniels, MD

Principal Investigator

St. Michael's Hospital (Toronto, Canada)

Johnny Lau, MD

Principal Investigator

TorontoWestern Hospital, Toronto Canada

Murry Penner, MD

Principal Investigator

British Columbia,Canada

Kevin Wing, MD

Principal Investigator

British Columbia, Canada

Dave Stevens, MD

Principal Investigator

Waterloo, Ontario Canada

Peter Dryden, MD

Principal Investigator

Victoria, British Columbia Canada

Craig Stone, MD

Principal Investigator

Newfoundland, Canada

Mark Glazebrook, MD

Principal Investigator

Capital District Health Authority, Halifax Canada

Alistair Younger, MD

Principal Investigator

British Columbia Canada

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ankle arthritis lasting more than six months, who haven't improved despite trying non-surgical treatments like physiotherapy or bracing. Participants must have severe symptoms as shown by questionnaires and be willing to consent to the study.

Inclusion Criteria

My ankle arthritis is severe according to recent tests.

I have had ankle arthritis for over 6 months.

I've tried treatments like physiotherapy without improvement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Total Ankle Arthroplasty or Ankle Arthrodesis

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and complications over a period of 10 years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Arthrodesis
• Total Ankle Arthroplasty

Trial Overview The study compares two surgical methods for treating ankle arthritis: Total Ankle Arthroplasty (replacement) versus Ankle Arthrodesis (fusion). It aims to determine which has better long-term success, fewer complications, and a lower rate of additional foot joint problems over ten years.

How Is the Trial Designed?

Group I: Ankle Arthroplasty Active Control 1 Intervention

Group II: Ankle Artrodeses Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ross Leighton

Lead Sponsor

Trials

5

Recruited

470+

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Canadian Orthopaedic Foot and Ankle Society

Collaborator

Trials

1

Recruited

250+

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12117774/

Comparing the efficacy of ankle arthrodesis performed ... Both the anterior approach and the lateral approach for the treatment of ankle arthritis can achieve good therapeutic effects, with no significant differences ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7001770/

Effectiveness and Safety of Ankle Arthrodesis Versus ... The objective of this study was to compare physical and mental function, ankle-specific function, pain intensity, and rates of revision surgery and minor ...

3. aaos.org aaos.org/aaosnow/2025/monday/research/research05/

Arthrodesis and Arthroplasty Show Similar Benefit for End- ... Ankle arthrodesis (AA) and total ankle arthroplasty (TAA) are both effective for end-stage ankle arthritis (ESAA) up to 8 years.

4. newsroom.uw.edu newsroom.uw.edu/news-releases/severe-ankle-arthritis-fusion-or-replacement-better

For severe ankle arthritis, is fusion or replacement better? Both types of surgical treatments are effective, UW Medicine study finds, but ankle replacement appears to have better outcomes overall after two years.

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03734-4

Clinical outcomes of surgical treatment for end-stage ankle ... This study aimed to clarify the clinical outcomes of surgical treatment for end-stage ankle osteoarthritis in patients aged ≥ 75 years and compare these ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40991861/

Clinical Outcomes and Safety Profile for Total Ankle ... Conclusion: Both TAA and AA are safe and effective surgical treatments for ankle arthritis. Among the data gathered in this systematic ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958259223000214

Safety and efficacy of total ankle arthroplasty versus ... Our results preferred total ankle arthroplasty over ankle arthrodesis in terms of lowering the rates of infections, amputations, and postoperative non-union.

8. medrxiv.org medrxiv.org/content/10.1101/2025.02.17.25322408v1.full-text

Long term consequences of Total Ankle Replacement ... Both TAR and AF are safe definitive treatments of ankle arthritis with low perioperative risk. TAR is associated with a significantly higher rate of further ...

9. mdpi.com mdpi.com/2077-0383/14/9/2909

Comparing Early Outcomes and Complications Between ... Comparing Early Outcomes and Complications Between Total Ankle Arthroplasty and Ankle Arthrodesis in Patients with Ankle Osteoarthritis: Big Data Analysis.