Actively Recruiting

Age: 18Years +
All Genders
NCT06654349

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

Led by Reinier Haga Orthopedisch Centrum · Updated on 2025-05-21

200

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Mentally disabled patients
  • Active infection
  • Current malignancy
  • Corticosteroid infiltration within the last 3 months
  • For TMC-joint arthroplasty group: trapezium height less than 8 mm

AI-Screening

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Trial Site Locations

Total: 1 location

1

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, Netherlands, 2725NA

Actively Recruiting

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Research Team

R

Rianne Oomen

CONTACT

N

Nina Mathijssen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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