Clinical trial NCT06820528: Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
Official title: Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CMC Arthritis
Occupational Therapy
Hand Arthritis
Keywords: CMC Arthroplasty
Thumb Arthritis
Hand Therapy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2025-02-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be prospectively enrolled into two arms
Primary purpose: TREATMENT

Brief summary: 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:

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).

Eligibility criteria: 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

Primary outcomes:
measure: Kapandji Score
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes:
measure: Radial Abduction (degrees)
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
measure: Key Pinch Strength (kg)
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
measure: Grip Strength (kg)
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
measure: PROMIS Upper Extremity
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
measure: PROMIS 29
timeFrame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Julia A.V. Nuelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.