NCT04458584: RESTART

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

Recruiting now Last updated 13 April 2025

What this trial tests

trial testing Trapeziectomy with ligament reconstruction (I; LRTI) in Osteoarthritis Thumb in 165 participants. Currently enrolling.

Timeline

29 June 2020

Primary endpoint
30 June 2026

31 December 2026

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	165
Start date	29 June 2020
Primary completion	30 June 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Osteoarthritis Thumb — all drugs for Osteoarthritis Thumb →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

21 and older, any sex, with Osteoarthritis Thumb. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.