Improving thumb strength and function for arthritis patients
Official title: Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Run by Dartmouth-Hitchcock Medical Center · NCT04458584 · Data updated 2026-11-12
This study is testing different surgical options for people with thumb arthritis to see which one helps improve strength, function, and reduce pain the most.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 165 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Status | Recruiting |
| Started | June 29, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT04458584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who are undergoing elective non-prosthetic, primary basal joint arthroplasty.
✕Probably not a fit
Patients with inflammatory arthritis or those undergoing simultaneous bilateral hand procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of different surgical interventions for thumb basal joint arthritis, focusing on trapeziectomy with ligament reconstruction, suture suspensionplasty, and arthroscopic trapeziectomy. It aims to determine which approach leads to better functional outcomes, strength, and pain relief. Participants will undergo one of the specified procedures and will be assessed through various clinical measures before and after surgery. The study will collect data on grip and pinch strength, as well as patient-reported outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance thumb strength and function for patients with basal joint arthritis.
How similar studies have gone: Other studies have shown varying degrees of success with similar surgical approaches, but this specific comparative effectiveness evaluation is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting
Study contacts
- Principal investigator: Vincent D Pellegrini, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Vincent D Pellegrini, MD
- Email: Vincent.D.Pellegrini.Jr@hitchcock.org
- Phone: (603) 650-5133
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Touch CMC 1 Thumb Joint Replacement in US: New Enrollment Observational Study
This US post-approval study tests how well the TOUCH CMC 1 prosthesis works and stays safe for people with thumb base arthritis who need a first CMC joint replacement.
-
National Registry for Artery Embolization to Treat Chronic Pain
This study is testing if a procedure that blocks blood flow to painful areas can help people with chronic pain from osteoarthritis and other conditions feel better.
-
Examining biomarkers in osteoarthritic thumb joints
This study is testing how certain markers in the thumb joints of people with osteoarthritis relate to their overall health and comparing them to knee joints, while also looking at grip strength and pain before and after surgery.
-
Surgery to fuse finger joints using the Kerifuse device
This study is testing a new device to see if it helps fuse finger joints in people with osteoarthritis faster and better than current methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.