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

NCT04458584 | Recruiting

• 1 other identifier: D20092
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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. 1.Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength,
2. 2.Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and
3. 3.Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique.
4. 4.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;
5. 5.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;
6. 6.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;
7. 7.Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position.
8. 8.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;
9. 9.Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and
10. 10.Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups.
11. 11.Compare postoperative neuritis and complications between surgical groups.

Conditions

Osteoarthritis Thumb

Keywords

Ligament reconstruction; Suspensionplasty; Arthroscopic Trapeziectomy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery

• Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.

  The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).

  Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery

• Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.

  The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).

  Baseline, 3 months and 6 months after surgery

• Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.

  The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.

  Baseline, 3 months and 6 months after surgery

Secondary Outcomes (3)

• Postoperative complications between procedure cohorts

  3 months and 6 months post surgery

• Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts

  Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery

• Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts

  Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery

Study Arms (3)

Ligament Reconstruction - Tendon Interposition (LRTI)

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

Procedure: Trapeziectomy with ligament reconstruction (I; LRTI)

Suture Suspensionplasty (SS)

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

Procedure: Trapeziectomy with suture suspensionplasty (II; SS)

Arthroscopic Trapeziectomy (AT)

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

Procedure: Arthroscopic Trapeziectomy (III; AT)

Interventions

Trapeziectomy with ligament reconstruction (I; LRTI) PROCEDURE

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

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

Ligament Reconstruction - Tendon Interposition (LRTI)

Trapeziectomy with suture suspensionplasty (II; SS) PROCEDURE

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

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

Suture Suspensionplasty (SS)

Arthroscopic Trapeziectomy (III; AT) PROCEDURE

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

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

Arthroscopic Trapeziectomy (AT)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients seen at participating centers who have failed non-operative treatment and are considering primary basal joint arthroplasty for a diagnosis of thumb basal joint osteoarthritis, post-traumatic arthritis, or have undergone a prior basal joint procedure for either fracture or instability resulting in persistent synovitis and are bothered by persistent symptoms, will be considered for participation in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Study Officials

• Vincent D Pellegrini, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent D Pellegrini, MD

CONTACT

(603) 650-5133; Vincent.D.Pellegrini.Jr@hitchcock.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Orthopaedics

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: June 29, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)