CMC ArthritisNCT06820528
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
A study testing Occupational Therapy and Home Exercise Program in people with CMC Arthritis and Occupational Therapy, run by Julie Nuelle at 1 site in United States.
Trial summary
The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMC Arthritis, Occupational Therapy, Hand Arthritis
- What is being tested?
- Occupational Therapy and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years
- Patients undergoing CMC Arthroplasty
- Ability to read and write in English
- Ability to provide informed consent
Who cannot join
- Patients undergoing revision CMC arthroplasty
- Acute traumatic dislocation of the CMC joint as indication for surgery
- Concomitant treatment of MCP hyperextension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vicki Jones, MEd, CCRP contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65212
Bryce Fletcher, BS, CCRP, (573) 882-2663, umhsorthoenroll@health.missouri.edu
Julia A.V. Nuelle, MD
About this study
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:
- The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP).
- 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).
- Conditions
- CMC Arthritis, Occupational Therapy, Hand Arthritis
- Being tested
- Occupational Therapy, Home Exercise Program
- Keywords
- CMC Arthroplasty, Thumb Arthritis, Hand Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Formal therapy with a certified hand therapist, weekly for 6 weeks
Home Exercise ProgramBehavioural
A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy | Experimental | Participants in this arm will receive weekly occupational therapy for 6 weeks Receives: Behavioral: Occupational Therapy |
| Home Exercise | Active comparator | Participants in this arm will complete an informal home exercise program provided by their treating physician Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes (5)
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
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
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CMC ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be prospectively enrolled into two arms
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie Nuelle
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor-investigator, Julie Nuelle, University of Missouri-Columbia
- Investigators
- Julia A.V. Nuelle, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820528
- Sponsor's protocol ID
- CMC-02062
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36126197Stirton 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 35081799Hutchinson 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 30063589Barret 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 37575026Barrett 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
- ClinicalTrials.gov ID
- NCT06820528
- Acronym / sponsor ID
- CMC-02062
- Conditions
- CMC Arthritis, Occupational Therapy, Hand Arthritis
- Keywords
- CMC Arthroplasty, Thumb Arthritis, Hand Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Julie NuelleUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty
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:
- The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be prospectively enrolled into two arms
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy | Experimental | Behavioral: Occupational TherapyParticipants in this arm will receive weekly occupational therapy for 6 weeks |
| Home Exercise | Active comparator | Behavioral: Home Exercise ProgramParticipants in this arm will complete an informal home exercise program provided by their treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18 years
- Patients undergoing CMC Arthroplasty
- Ability to read and write in English
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Patients undergoing revision CMC arthroplasty
- Acute traumatic dislocation of the CMC joint as indication for surgery
- Concomitant treatment of MCP hyperextension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyFormal therapy with a certified hand therapist, weekly for 6 weeks | Behavioural | Occupational Therapy |
| Home Exercise ProgramA booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises | Behavioural | Home Exercise |
Primary outcome
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.
5 secondary outcomes
Radial Abduction (degrees)
Time frame: 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
Grip Strength (kg)
Time frame: 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
PROMIS 29
Time frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 36126197Stepan 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.
- Background: PubMed 35081799Stirton 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.
- Background: PubMed 30063589Hutchinson 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.
- Background: PubMed 37575026Barret 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.
- Background: PubMed 38608035Barrett 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicki Jones, MEd, CCRP contact
Julia A.V. Nuelle, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Home Exercise Program in people with CMC Arthritis and Occupational Therapy, run by Julie Nuelle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryce T Fletcher, BS, CCRP ((573) 882-2663, umhsorthoenroll@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kapandji Score (time frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820528, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.