Treatment of Thumb Carpometacarpal (CMC) Arthritis Using Stablyx® CMC Arthroplasty System
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. 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