Actively Recruiting
Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-04-13
165
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three common beliefs about surgical treatments for thumb basal joint arthritis, focusing on how different surgical methods affect strength, pain, and function. The study compares procedures involving ligament reconstruction and metacarpal stabilization with simpler trapeziectomy surgery, aiming to understand which approach best improves grip, pinch strength, and overall hand function. It also explores how preserving the joint space and controlling joint extension impacts recovery and outcomes. Participants will undergo one of three surgical procedures: trapeziectomy with ligament reconstruction-tendon interposition (LRTI), trapeziectomy with suture suspensionplasty (SS), or arthroscopic trapeziectomy with temporary K-wire fixation (AT). Before surgery, patients receive a lidocaine injection to the joint to assess pain and strength changes. Follow-up assessments occur at three and six months post-surgery, including strength measurements, pain and function surveys, and clinical evaluations. During the study, participants complete questionnaires measuring pain, arm and hand function, and overall health, alongside grip and pinch strength tests. Surgeons assess sensitivity and complications at follow-up visits. X-rays and joint measurements help evaluate joint space and alignment changes. The study tracks patient-reported outcomes and clinical data before surgery, shortly after lidocaine injection, and at 3 and 6 months after surgery to understand recovery and effectiveness of each procedure.
CONDITIONS
Brief Title
Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 21 years of age or older
- Undergoing elective non-prosthetic, primary basal joint arthroplasty
- Have the mental capacity to participate and follow the study protocol
- Willing and able to give informed consent
- Willing to participate under the care of their chosen surgeon
You will not qualify if you...
- Diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis
- Undergoing simultaneous bilateral hand procedures
- Women who are pregnant or breastfeeding
- Women of reproductive potential without a negative pregnancy test on the day of surgery
- Vulnerable populations including prisoners and institutionalized individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to collect baseline clinical and demographic information and complete questionnaires
Duration - Day of surgery
Participants undergo one of three thumb basal joint arthroplasty procedures to treat osteoarthritis: trapeziectomy with ligament reconstruction-tendon interposition (LRTI), trapeziectomy with suture suspensionplasty, or arthroscopic trapeziectomy with temporary K-wire fixation. Local anesthetic is used before surgery to assess pain and function.
1 visit (in-person) on surgery day including anesthesia and procedure
Duration - Up to 6 months after surgery
Participants follow routine postoperative rehabilitation and hand therapy protocols as directed by their surgeon. Protective splinting and exercise programs are used as appropriate.
Follow-up visits scheduled by the surgeon according to routine care and clinical indication
Duration - 3 and 6 months post surgery
Participants are assessed at 3 and 6 months after surgery for pain, function, and strength using surveys and physical measurements. The surgeon or hand therapist also evaluates sensitivity and any complications.
2 visits (in-person) at 3 months and 6 months post surgery
Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
V
Vincent D Pellegrini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here