Back to search results

Observational Study on Thumb Basal Joint Arthritis Surgery

This observational study, called RESTART, is looking at different surgical methods for thumb basal joint arthritis (osteoarthritis of the thumb). It compares three types of surgery: Trapeziectomy with ligament reconstruction (LRTI), Trapeziectomy with suture suspensionplasty (SS), and Arthroscopic Trapeziectomy (AT). The study aims to understand which surgery leads to better thumb strength and function, less pain, and improved daily activities. You might be able to join if you are 21 or older, having one of these specific surgeries, and are willing to participate with your chosen surgeon. The researchers will measure changes in your pinch and grip strength, pain levels using a visual scale, and how well you can use your arm, shoulder, and hand using a questionnaire, both before and after surgery.

Study design
This is an observational study with a planned enrollment of 165 participants. It compares three different surgical procedures for thumb basal joint arthritis.
What's involved
You will have baseline measurements taken before surgery, including strength, pain, and function questionnaires. After surgery, these measurements will be repeated at 3 and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after surgery to assess changes in strength, pain, and function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04458584

Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)

Recruiting
Not specifiedAges 21+Observational
Dartmouth-Hitchcock Medical Center
~165 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Trapeziectomy with ligament reconstruction (I; LRTI)Trapeziectomy with suture suspensionplasty (II; SS)Arthroscopic Trapeziectomy (III; AT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.
Measured over Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
+3 more outcomes measured

Conditions

Osteoarthritis Thumb

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
New Hampshire1

Study leadership

  • Vincent D Pellegrini, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Vincent D Pellegrini, MD
[email protected]
(603) 650-5133
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.

What this trial measures

  • Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery

    Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing.

  • Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery

    The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).

  • Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.Baseline, 3 months and 6 months after surgery

    The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).

  • Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.Baseline, 3 months and 6 months after surgery

    The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.