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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-002500
    Sponsor Protocol Number: 15-002500

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

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

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CLS-20309543

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