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

NCT ID: NCT04458584

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2026-12-31

Brief 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-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.

Detailed Description

Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of surgery, each site coordinator will collect baseline clinical and demographic information, a visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the same day, and immediately following collection of baseline clinical data in the clinic, the surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15 minutes set time for the local anesthetic, the VAS diagram will again be completed by the patient followed by recording of repeat grip and then pinch measurements. Each patient will then undergo one of three pre-specified procedures; trapeziectomy with ligament reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon; trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's routine and by clinical indication only. The patient will follow the routine postoperative rehabilitation protocol and hand therapy program of the operating surgeon. Protective splinting and exercise programs are to be utilized per surgeon protocol and preference.Postoperative study assessment will occur at three and six months after operation, The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally, specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made by the surgeon or hand therapist at the 3 and 6 month assessments.

Conditions

Osteoarthritis Thumb

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Ligament Reconstruction - Tendon Interposition (LRTI)

Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis.

Trapeziectomy with ligament reconstruction (I; LRTI)

Intervention Type: PROCEDURE

Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)

Suture Suspensionplasty (SS)

Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis.

Trapeziectomy with suture suspensionplasty (II; SS)

Intervention Type: PROCEDURE

Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)

Arthroscopic Trapeziectomy (AT)

Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis.

Arthroscopic Trapeziectomy (III; AT)

Intervention Type: PROCEDURE

Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)

Interventions

Trapeziectomy with ligament reconstruction (I; LRTI)

Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)

Intervention Type: PROCEDURE

Trapeziectomy with suture suspensionplasty (II; SS)

Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)

Intervention Type: PROCEDURE

Arthroscopic Trapeziectomy (III; AT)

Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)

Intervention Type: PROCEDURE

Other Intervention Names

NOTE: NO devices or drugs are included as part of this intervention.; NOTE: NO devices or drugs are included as part of this intervention.; NOTE: NO devices or drugs are included as part of this intervention.

Eligibility Criteria

Inclusion Criteria

• 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; and
• Patient is willing to participate under the care of their chosen surgeon.

Exclusion Criteria

• Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis;
• Patients undergoing simultaneous bilateral hand procedures of any nature;
• Women who are pregnant or breastfeeding;
• Women of reproductive potential unless there is a negative urine pregnancy test on the day of surgery. Women of child bearing potential include those who are premenopausal who have not had a bilateral oophorectomy, hysterectomy or tubal ligation. Post-menopausal is defined as not having had a menstrual period for at least one calendar year.
• Vulnerable patient populations including prisoners and institutionalized individuals.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vincent D. Pellegrini

Staff Physician, Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent D Pellegrini, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vincent D Pellegrini, MD

Role: CONTACT

Vincent.D.Pellegrini.Jr@hitchcock.org

(603) 650-5133

Facility Contacts

Vincent D Pellegrini, MD

Role: primary

Vincent.D.Pellegrini.Jr@hitchcock.org

603-650-5133

Lance G Warhold, MD

Role: backup

Lance.G.Warhold@hitchcock.org

(603) 650-5133

Other Identifiers

D20092

Identifier Type: -

Identifier Source: org_study_id