Ensayos clínicos

Inclusion Criteria:

• Subject understands the nature of the procedure and provides written informed consent.
• The patient is willing to be available for the appropriate follow-up for the duration of the study.
• Patient is considered a candidate for Thumb Hemiarthroplasty using Stablyx (should indicate which of the following apply)
  • Osteoarthritis of the Thumb CMC joint, Eaton Stage II-IV
  • Rheumatoid or Traumatic arthritis of the Thumb CMC joint
  • Post fracture deformation or bone loss that presents as either a painful, unstable thumb, or a thumb with limited range of motion
• Patient has adequate bone and soft tissue quality

Exclusion Criteria: 

• Patient has one of the following conditions:
  • Active infection, suspicion of colonization or latent infection
  • Insufficient quantity or quality of bone and/or soft tissue
  • Material sensitivity
• Patient is unwilling or unable to follow post-operative study and/or rehabilitation protocol including (but not limited to) the following items:
  • Non-compliance
  • Unable to adhere to protocol due to mental status
  • Lacks transportation or other means to attend follow-up visits