Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?

April 22, 2025 updated by: Julie Nuelle
The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

While hand surgeons agree that strength and flexibility exercises are crucial after surgery, there is currently no consensus on whether the benefits of participating in formal hand therapy outweigh the investment required. The financial and time investments required to participate in formal hand therapy can be particularly large in patients living in rural locations, as access to certified hand therapists are often limited. Therefore, a prospective, randomized trial of hand therapy utilization is warranted to explore this phenomenon. The purpose of this clinical trial is to assess the outcomes for post-operative therapy from in-clinic or at-home exercise therapies and analyze costs associated with the different therapies. For this clinical trial patients will be randomized to either in-clinic occupational therapy where patients come into clinic and undergo about 30-60 minutes of occupational therapy 1-2 a week with a physician or at-home exercise therapy where patients are provided instructions in clinic prior to HEP-therapy and have check-ins with physicians at their normal follow-up appointments; each consisting of about 5-10 minutes of exercise at home everyday of the week.

This study is a prospective, randomized, controlled trial to asses and analyze:

  1. The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP).
  2. The cost difference between the OT and HEP groups as well as historical control patients that have undergone LRTI for thumb carpometacarpal joint arthritis (Including preoperative, intra-operative, and postoperative costs).

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri - Columbia
        • Contact:
        • Contact:
          • Julia A.V. Nuelle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over the age of 18 years
  • Patients undergoing CMC Arthroplasty
  • Ability to read and write in English
  • Ability to provide informed consent

Exclusion Criteria:

  • Patients undergoing revision CMC arthroplasty
  • Acute traumatic dislocation of the CMC joint as indication for surgery
  • Concomitant treatment of MCP hyperextension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occupational Therapy
Participants in this arm will receive weekly occupational therapy for 6 weeks
Behavioral: Occupational Therapy
Formal therapy with a certified hand therapist, weekly for 6 weeks
Active Comparator: Home Exercise
Participants in this arm will complete an informal home exercise program provided by their treating physician
Behavioral: Home Exercise Program
A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kapandji Score
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
The Kapandji score is a widely used clinical metric for evaluating thumb opposition. It assesses the movement and functional reach of the thumb across into the palm and to the bases of the other fingers. The score ranges from 0 to 10, with each point representing the thumb's ability to touch distinct anatomical landmarks on the hand: from the radial side of the index finger base (score of 1) to the ulnar side of the little finger base (score of 10). This score helps in determining the functional impairment and potential recovery in cases involving thumb or hand injuries, often used in pre- and post-operative assessments.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial Abduction (degrees)
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Radial abduction refers to the movement of the thumb away from the hand's plane towards the radius, or the lateral side of the forearm. This motion is crucial for grasping larger objects and is an important aspect of hand function. It is commonly measured during hand and thumb functional assessments to evaluate the range of motion and strength, particularly after injury or surgery. Radial abduction is facilitated by several muscles, including the abductor pollicis longus, which plays a pivotal role in thumb movement and positioning.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Key Pinch Strength (kg)
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Key pinch, also known as lateral pinch, involves the force applied between the thumb pad and the lateral side of the index finger. This specific type of pinch is crucial for activities that require precision, such as holding a key or grasping small objects. The key pinch is commonly assessed in occupational therapy and rehabilitation settings to evaluate hand function and grip strength, particularly after injury or in conditions affecting the nerves or muscles of the hand. Measurements are typically taken using a pinch gauge, which provides a quantitative value of pinch strength, helping in the assessment and monitoring of recovery progress.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Grip Strength (kg)
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Grip strength is the force applied by the hand to pull or suspend objects and is a key indicator of hand function and overall health. It's measured using a dynamometer, an instrument that the individual squeezes with maximum effort.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
PROMIS Upper Extremity
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
The PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity measure is a tool designed to assess self-reported upper extremity function. This measure evaluates the physical functioning and capability of the arms, shoulders, and hands based on the patient's perspective. Scores from this assessment are converted to a T-score metric, where 50 represents the mean of a relevant reference population, and each 10-point deviation represents one standard deviation from that mean. This standardization allows for the comparison of patient scores against population norms, which can be particularly useful in clinical trials, patient care, and research studies involving musculoskeletal health and rehabilitation.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
PROMIS 29
Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
The PROMIS-29 profile is a comprehensive tool that measures health across multiple domains using patient-reported outcomes. It evaluates seven key health domains along with pain intensity, offering a broad overview of a patient's health status. The domains include physical function, which assesses the ability to carry out physical activities; anxiety, evaluating feelings like fear and unease; depression, measuring feelings such as sadness and lack of interest; fatigue, assessing how often a patient feels tired; sleep disturbance, measuring perceptions of sleep quality; social roles and activities, evaluating the extent to which health limits participation in various activities; and pain interference, which assesses how pain hampers engagement in daily activities. Additionally, pain intensity is captured on a scale from 0 (no pain) to 10 (worst imaginable pain). Each domain consists of four questions, totaling 29 items. This tool is designed to be generic, suitable for a wide range of
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Nuelle

Collaborators

Arthrex, Inc.

Investigators

  • Principal Investigator: Julia A.V. Nuelle, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-02062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the sensitive nature of the data collected in this study, including potentially identifiable health information, we have decided not to share individual participant data with other researchers. This decision is guided by the need to strictly adhere to the privacy and confidentiality assurances provided to our participants at the time of consent. Moreover, the specific terms of participant consent do not allow for the sharing of their data beyond the scope of this research project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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