Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
1 other identifier
interventional
180
1 country
1
Brief Summary
The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 25, 2025
April 1, 2025
2.2 years
February 5, 2025
April 22, 2025
Conditions
Keywords
Outcome Measures
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.
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Secondary Outcomes (5)
Radial Abduction (degrees)
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Key Pinch Strength (kg)
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Grip Strength (kg)
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
PROMIS Upper Extremity
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
PROMIS 29
2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Study Arms (2)
Occupational Therapy
EXPERIMENTALParticipants in this arm will receive weekly occupational therapy for 6 weeks
Home Exercise
ACTIVE COMPARATORParticipants in this arm will complete an informal home exercise program provided by their treating physician
Interventions
Formal therapy with a certified hand therapist, weekly for 6 weeks
A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises
Eligibility Criteria
You may qualify if:
- Patients over the age of 18 years
- Patients undergoing CMC Arthroplasty
- Ability to read and write in English
- Ability to provide informed consent
You may not qualify if:
- Patients undergoing revision CMC arthroplasty
- Acute traumatic dislocation of the CMC joint as indication for surgery
- Concomitant treatment of MCP hyperextension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Julie Nuellelead
- Arthrex, Inc.collaborator
Study Sites (1)
University of Missouri - Columbia
Columbia, Missouri, 65212, United States
Related Publications (5)
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.
PMID: 36126197BACKGROUNDStirton 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.
PMID: 35081799BACKGROUNDHutchinson 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.
PMID: 30063589BACKGROUNDBarret 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.
PMID: 37575026BACKGROUNDBarrett 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.
PMID: 38608035BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia A.V. Nuelle, MD
University of Missouri-Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 11, 2025
Study Start
April 17, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
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.