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

Recruitingn/aAges 21 Years - anyAllDartmouth-Hitchcock Medical Center
NCT04458584 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 and metacarpal stabilization is associated with superior functional outcomes and strength, 2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and 3. Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique. It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by either ligament reconstruction (I) or suture suspension (II), provides greater improvement in grip and pinch strength, and better hand function, than might be achieved following provision of pain rel

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📋 Eligibility rules (as published)
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.
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What it tests

  • Trapeziectomy with ligament reconstruction (I; LRTI)
  • Trapeziectomy with suture suspensionplasty (II; SS)
  • Arthroscopic Trapeziectomy (III; AT)
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Where

1 site
Dartmouth-Hitchcock Medical Center
Lebanon, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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