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RecruitingNCT06820528Updated Jun 5, 2026

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

An interventional study of Occupational Therapy and Home Exercise Program in CMC Arthritis, Occupational Therapy and Hand Arthritis, sponsored by Julie Nuelle. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Julie Nuelle · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).
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Conditions studied

  • CMC Arthritis
  • Occupational Therapy
  • Hand Arthritis

Keywords

  • CMC Arthroplasty
  • Thumb Arthritis
  • Hand Therapy
03

In context

Lead sponsor

Julie Nuelle is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients undergoing revision CMC arthroplasty
  • Acute traumatic dislocation of the CMC joint as indication for surgery
  • Concomitant treatment of MCP hyperextension
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Occupational Therapy

    Participants in this arm will receive weekly occupational therapy for 6 weeks

    Behavioral: Occupational Therapy

  • Active comparator
    Home Exercise

    Participants in this arm will complete an informal home exercise program provided by their treating physician

    Behavioral: Home Exercise Program

Interventions

  • BehavioralOccupational Therapy

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

  • BehavioralHome Exercise Program

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

06

What researchers measure

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

  5. PROMIS 29

    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

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

07

Study locations

1 of 1 sites recruiting
  • University of Missouri - Columbia
    Columbia, Missouri 65212, United States
    Recruiting
08

References and documents

Publications

  • Stepan JG, Rolf L, Zhu E, Brody M, Landau AJ, Calfee RP, Dy CJ. Patient Perspectives after Trapeziectomy and Ligament Reconstruction Tendon Interposition: A Qualitative Analysis. Plast Reconstr Surg. 2022 Dec 1;150(6):1275e-1282e. doi: 10.1097/PRS.0000000000009676. Epub 2022 Sep 20. PubMed 36126197 ↗
  • Stirton JB, Kagy KL, Mooney ML, Jain MK, Skie M. Early Mobilization After Basal Joint Arthroplasty: Clinical Results. Hand (N Y). 2023 Mar;18(2_suppl):81S-86S. doi: 10.1177/15589447211038699. Epub 2022 Jan 26. PubMed 35081799 ↗
  • Hutchinson DT, Sueoka S, Wang AA, Tyser AR, Papi-Baker K, Kazmers NH. A Prospective, Randomized Trial of Mobilization Protocols Following Ligament Reconstruction and Tendon Interposition. J Bone Joint Surg Am. 2018 Aug 1;100(15):1275-1280. doi: 10.2106/JBJS.17.01157. PubMed 30063589 ↗
  • Barret PC, Hackley DT, Lockhart ES, Yu-Shan AA, Bravo CJ, Apel PJ. What Factors Influence Variability in Thumb Carpometacarpal Arthroplasty Care? A Survey of ASSH Members. Hand (N Y). 2025 Jan;20(1):129-135. doi: 10.1177/15589447231188454. Epub 2023 Aug 14. PubMed 37575026 ↗
  • Barrett PC, Hackley DT, Yu-Shan AA, Shumate TG, Larson KG, Deneault CR, Bravo CJ, Peterman NJ, Apel PJ. Provision of a Home-Based Video-Assisted Therapy Program Is Noninferior to In-Person Hand Therapy After Thumb Carpometacarpal Arthroplasty. J Bone Joint Surg Am. 2024 Apr 17;106(8):674-680. doi: 10.2106/JBJS.23.00597. Epub 2024 Apr 12. PubMed 38608035 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06820528
Lead sponsor
Julie Nuelle
Collaborators
Arthrex, Inc.
Responsible party
Julie Nuelle (Assistant Professor, University of Missouri-Columbia) — Sponsor-investigator
First posted
Feb 11, 2025
Start date
Apr 17, 2025
Primary completion
Jul 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Jun 5, 2026

Study contacts

Bryce T Fletcher, BS, CCRP
Contact
umhsorthoenroll@health.missouri.edu
(573) 882-2663
Vicki Jones, MEd, CCRP
Contact
umhsorthoenroll@health.missouri.edu
Julia A.V. Nuelle, MD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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