Actively Recruiting

Age: 21Years +
All Genders
NCT04458584

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

339 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space will correlate positively, and MCPJ hyperextension will correlate negatively, with improved thumb function and lateral pinch strength. Primary Aims (within 3 procedure cohorts): 1. Compare pre-operative pinch and grip strength as well as patient-reported outcomes (PROs) for pain in patients before and after lidocaine injection of the trapeziometacarpal joint, prior to thumb basal joint arthroplasty; 2. Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6 months after thumb basal joint arthroplasty with pre-operative values before and after lidocaine injection; 3. Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph with postoperative improvement in pinch and grip strength, and PROs for pain and function; 4. Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position. Secondary Aims (between 3 procedure cohorts): 1. Compare change in pre- and post-operative pinch and grip strength and PROs for pain and function between patients having basal joint arthroplasty with and without specific metacarpal stabilization; 2. Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and 3. Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups. 4. Compare postoperative neuritis and complications between surgical groups.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Patient is willing to participate under the care of their chosen surgeon
Not Eligible

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 of any nature
  • Women who are pregnant or breastfeeding
  • Women of reproductive potential without a negative urine pregnancy test on the day of surgery
  • Vulnerable populations including prisoners and institutionalized individuals

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

V

Vincent D Pellegrini, MD

CONTACT

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

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