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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.

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.

What data supports the effectiveness of the treatment Ankle Arthrodesis, Total Ankle Arthroplasty for ankle arthritis?

Ankle arthrodesis (fusion of the ankle joint) is a well-established treatment for severe ankle arthritis, showing reliable outcomes and improved function, especially in active patients. Total ankle arthroplasty (replacement of the ankle joint) is also effective, preserving joint motion and improving quality of life due to advancements in surgical techniques and prosthesis design. ^{1 2 3 4 5}

Is surgical treatment for ankle arthritis safe?

Surgical treatments like total ankle arthroplasty (replacement) and ankle arthrodesis (fusion) are generally considered safe, but they can have complications. Total ankle arthroplasty has improved with modern techniques and designs, but it still has variable complication rates. Ankle arthrodesis is effective but may lead to issues like limited motion and altered walking patterns. ^{3 6 7 8 9}

How does the treatment of ankle arthrodesis and total ankle arthroplasty differ from other treatments for ankle arthritis?

Total ankle arthroplasty (TAA) is unique because it preserves motion at the ankle joint, unlike ankle arthrodesis, which fuses the joint and eliminates movement. This makes TAA a popular alternative for those seeking to maintain joint flexibility, thanks to modern implantation techniques and improved prosthesis designs. ^{3 7 10 11 12}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transfibular ankle arthrodesis: A novel method for ankle fusion - A short term retrospective study. [2020]

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

Arthroscopic Ankle Arthrodesis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Update on total ankle arthroplasty]. [2020]

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

Sport and Exercise Activity After Isolated Ankle Arthrodesis for Advanced-Stage Ankle Osteoarthritis: A Single-Center Retrospective Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Arthroscopic arthrodesis for ankle arthritis without bone graft. [2022]

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

A Systematic Review and Meta-analysis of Total Ankle Arthroplasty or Ankle Arthrodesis for Treatment of Osteoarthritis in Patients With Diabetes. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Complication rates after total ankle arthroplasty in one hundred consecutive prostheses. [2021]

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

Long-term Functional and Radiographic Outcome of a Mobile Bearing Ankle Prosthesis. [2017]

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

5 points on total ankle arthroplasty. [2014]

10. China pubmed.ncbi.nlm.nih.gov

[Meta-analysis of clinical efficacy of ankle arthrodesis and total ankle arthroplasty in the treatment of end-stage ankle arthritis]. [2023]

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

Performance of total ankle arthroplasty and ankle arthrodesis on uneven surfaces, stairs, and inclines: a prospective study. [2022]

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

Effectiveness and Safety of Ankle Arthrodesis Versus Arthroplasty: A Prospective Multicenter Study. [2021]