Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study (THUMB Diary)

Reinier Haga Orthopedisch Centrum

Status: Enrolling

Conditions: Arthrosis of First Carpometacarpal Joint

Study type: Observational

Funder types: Other

Identifiers

NCT06654349

OC-2024-001

N24.085 (Other Identifier)

Details and patient eligibility

About

Rationale: The trapeziometacarpal (TMC) joint is one of the most common areas in the hand and wrist to develop osteoarthritis (OA). Currently, the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty, both with their own pros and cons. No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy. And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty.

Objective: To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain, pain medication, function and quality of life.

Study design: A prospective observational cohort diary study.

Study population: In total 200 subjects with TMC-joint osteoarthritis will participate: 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty

Main study parameters/endpoints: The main study parameters are the pain, function and quality of life during the first 8 weeks after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have no direct benefit from participation in this study. Subjects will only complete a diary and questionnaires for this study. Therefore, we expect no risks from participation. The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Failed conservative treatment for osteoarthritis
• Planned for trapeziectomy or TMC-joint arthroplasty
• Age 18-75 years
• Willing and able to comply with the postoperative functional assessment and to participate in a rehabilitation schedule

Exclusion criteria

• Mentally disabled patients
• Active infection
• Current malignancy
• Infiltration (corticoids < 3 months)

The following criteria is specific for the TMC-joint arthroplasty group and is an addition to the criteria mentioned above:

• Trapezium height < 8 mm

Trial design

200 participants in 2 patient groups

Trapeziectomy

Description:

This cohort consist of patients receiving a trapeziectomy for arthrosis of the first carpometacarpal joint. The cohort will include 100 patients

TMC-arthroplasty

Description:

This cohort consist of patients receiving TMC-arthroplasty for arthrosis of the first carpometacarpal joint. The cohort will include 100 patients