Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

Nova Scotia Health Authority (NSHA)

Status: Active, not recruiting

Conditions: Ankle Arthritis

Treatments: Procedure: Ankle Arthroplasty; Procedure: Ankle Arthrodesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00552136

CDHA-MG-001

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eighteen (18) or older
• Known to have ankle arthritis for more than six (6) months
• Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved
• Patient tests (questionnaires) show that ankle arthritis is severe
• Patient willing to take part in the study, including signing consent form after carefully reading it

Exclusion criteria

• Dead Bone in the Ankle
• Severe foot or Ankle Deformity
• Prior Ankle Fusion or Replacement
• Active or Prior Infection in the Ankle
• Obesity (greater than 250 lbs)
• Medical Conditions precluding safe surgery
• Nerve or Muscle disease
• Severe osteoporosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Ankle Arthroplasty

Active Comparator group

Treatment:

Procedure: Ankle Arthroplasty

Ankle Artrodeses

Active Comparator group

Treatment:

Procedure: Ankle Arthrodesis