Comparing Ankle Fusion to Ankle Replacement

Active, not recruitingOBSERVATIONAL
Enrollment

516

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
End-stage Ankle Arthritis (ESAA)Osteoarthritis (OA)
Interventions
PROCEDURE

Ankle Arthrodesis

All surgeons will employ a well-established technique of rigid internal fixation. In this technique, the joint is prepared by removing cartilage from the surfaces, the bones are positioned as desired, and screws and/or a plate are attached to compress the bones together and prevent motion. This technique obviates the need for a cast or external support. Patients are allowed to walk with weight bearing aids immediately. Radiographs are performed at 6 weeks to determine weight bearing status. Weight is allowed on the limb in increments over the 6 to 12 weeks after surgery.

PROCEDURE

Ankle Arthroplasty

Protocols are similar among participating centers. Each surgeon uses an anterior surgical approach between the tibialis anterior tendon and the toe extensor group, splints the ankles for 2 weeks, and restricts weight bearing for the first 6 weeks. Radiographs are performed at 6 weeks to determine weight bearing status. The study involves only FDA approved implants with which the surgeon has established experience.

Trial Locations (6)

49525

Orthopaedic Associates of Michigan, Grand Rapids

55435

Twin Cities Orthopedics, Edina

80525

Orthopaedic and Spine Center of the Rockies, Fort Collins

97225

Orthopedic + Fracture Specialists, Portland

98104

Harborview Medical Center, Seattle

98108

VA Puget Sound Health Care System, Seattle

All Listed Sponsors
collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

collaborator

National Institutes of Health (NIH)

NIH

collaborator

University of Washington

OTHER

collaborator

Orthopedic + Fracture Specialists, Portland, OR

OTHER

collaborator

Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics

UNKNOWN

collaborator

Orthopaedic and Spine Center of the Rockies

UNKNOWN

collaborator

Orthopaedic Associates of Michigan, PC

OTHER

lead

Seattle Institute for Biomedical and Clinical Research

OTHER

NCT01620541 - Comparing Ankle Fusion to Ankle Replacement | Biotech Hunter | Biotech Hunter