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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT04458584
Status
Recruiting
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Conditions

  • Osteoarthritis Thumb

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trapeziectomy with ligament reconstruction (I; LRTI) — PROCEDURE
    Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)
  • Trapeziectomy with suture suspensionplasty (II; SS) — PROCEDURE
    Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)
  • Arthroscopic Trapeziectomy (III; AT) — PROCEDURE
    Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)

Study Details

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.

Key Dates

Start date
Jun 29, 2020
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
165 participants (estimated)

Arms

  • Arm: Ligament Reconstruction - Tendon Interposition (LRTI)
    Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis.
  • Arm: Suture Suspensionplasty (SS)
    Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis.
  • Arm: Arthroscopic Trapeziectomy (AT)
    Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis.

Primary Outcome Measure

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. [ Time Frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Vincent D Pellegrini, MD
[email protected]
603-650-5133
Lance G Warhold, MD
[email protected]
(603) 650-5133
Lance G Warhold, MD (SUB_INVESTIGATOR)
Jennifer A Chickering, OTR, CHT (SUB_INVESTIGATOR)

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