Treatment of Thumb Carpometacarpal (CMC) Arthritis Using Stablyx® CMC Arthroplasty System

Overview

About this study

The purpose of this study is to determine is the Stablyx ® CMC arthroplasty system provides acceptable outcomes for patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Bassem Elhassan, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20309543

Mayo Clinic Footer