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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJulie Nuelle

About this trial

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over the age of 18 years

Patients undergoing CMC Arthroplasty

Ability to read and write in English

Ability to provide informed consent

Disqualifiers

Patients undergoing revision CMC arthroplasty

Acute traumatic dislocation of the CMC joint as indication for surgery

Concomitant treatment of MCP hyperextension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Occupational Therapy

    Behavioral

    Formal therapy with a certified hand therapist, weekly for 6 weeks

  • Home Exercise Program

    Behavioral

    A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Occupational TherapyExperimental treatment 1 intervention
Group B: Home ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Kapandji Score

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.

Time frame
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year

Secondary outcomes

1

Radial Abduction (degrees)

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.

Time frame
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
2

Key Pinch Strength (kg)

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.

Time frame
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
3

Grip Strength (kg)

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.

Time frame
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
4

PROMIS Upper Extremity

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.

Time frame
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Julie Nuelle

Lead sponsor

University of Missouri-Columbia

Sponsor institution

Arthrex, Inc.

Collaborator