Improving thumb strength and function for arthritis patients
Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Dartmouth-Hitchcock Medical Center · NCT04458584
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 |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT04458584 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who are undergoing elective non-prosthetic, primary basal joint arthroplasty.
Not a fit: Patients with inflammatory arthritis or those undergoing simultaneous bilateral hand procedures may not benefit from this study.
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 performed: Other studies have shown varying degrees of success with similar surgical approaches, but this specific comparative effectiveness evaluation is novel.
Eligibility criteria
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 this trial is running
Lebanon, New Hampshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis Thumb, Ligament reconstruction, Suspensionplasty, Arthroscopic Trapeziectomy