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NCT04458584 · ClinicalTrials.gov registry record

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

A clinical trial of Osteoarthritis Thumb, sponsored by Dartmouth-Hitchcock Medical Center.

Recruiting
Registry status
165
Enrollment target
1
Study location

NCT04458584: Recruiting study of Osteoarthritis Thumb, sponsored by Dartmouth-Hitchcock Medical Center.

NCT04458584 is a study of Osteoarthritis Thumb that is actively recruiting participants, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 165 participants, below the 424-participant average among 3 other Osteoarthritis Thumb trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04458584, a study of Osteoarthritis Thumb, is actively recruiting participants, sponsored by Dartmouth-Hitchcock Medical Center.

RECRUITING
Registry status
165 participants
Enrollment target
1
Study location

Study Summary

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-ope

Primary Outcome

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.

Conditions Studied

Interventions

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

Study Locations (1)

New Hampshire

  • Dartmouth-Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2020-06-29
Est. Completion 2026-12-31
Dartmouth-Hitchcock Medical Center

427 total trials

What NCT04458584 shows while recruiting

NCT04458584 is an observational study that tracks outcomes without assigning an intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 424-participant average among 3 other Osteoarthritis Thumb trials with a reported enrollment target (61% lower).

The record links to 1 condition, with Osteoarthritis Thumb appearing as the primary indexed condition, and to 3 interventions - of which Trapeziectomy with ligament reconstruction (I; LRTI) is the first listed.

NCT04458584 reports a single indexed study location in New Hampshire.

Frequently Asked Questions

What is clinical trial NCT04458584 about?

NCT04458584 is a clinical study titled "Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)". 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. Preser...

What is the current status of trial NCT04458584?

This trial is currently recruiting. The enrollment target is 165 participants. The study started on 2020-06-29. Estimated completion is 2026-12-31.

What conditions does trial NCT04458584 study?

This clinical trial studies the following conditions: Osteoarthritis Thumb.

What interventions are being tested in trial NCT04458584?

The interventions under investigation include: Trapeziectomy with ligament reconstruction (I; LRTI) (PROCEDURE), Trapeziectomy with suture suspensionplasty (II; SS) (PROCEDURE), Arthroscopic Trapeziectomy (III; AT) (PROCEDURE).

Who is sponsoring clinical trial NCT04458584?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04458584 being conducted?

This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04458584, the US trial registry maintained by the National Library of Medicine. NCT04458584 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.