Status:
RECRUITING
Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Osteoarthritis Thumb
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis; 1. Trapeziectomy with ligament reconstruction ...
Detailed Description
Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of surgery, each site coordinator will collect baseline clinical and demographic information, a visual analogue...
Eligibility Criteria
Inclusion
- Males and females 21 years of age or older;
- Undergoing elective non-prosthetic, primary basal joint arthroplasty;
- Patient has necessary mental capacity to participate and comply with study protocol;
- Patient is willing and able to give informed consent; and
- Patient is willing to participate under the care of their chosen surgeon.
Exclusion
- Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis;
- Patients undergoing simultaneous bilateral hand procedures of any nature;
- Women who are pregnant or breastfeeding;
- Women of reproductive potential unless there is a negative urine pregnancy test on the day of surgery. Women of child bearing potential include those who are premenopausal who have not had a bilateral oophorectomy, hysterectomy or tubal ligation. Post-menopausal is defined as not having had a menstrual period for at least one calendar year.
- Vulnerable patient populations including prisoners and institutionalized individuals.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04458584
Start Date
June 29 2020
End Date
December 31 2026
Last Update
April 13 2025
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756