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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 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.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458584
The ClinicalTrials.gov registry entry for NCT04458584 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 424-participant average among 3 other Osteoarthritis Thumb trials with a reported enrollment target (61% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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