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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthrosis of First Carpometacarpal Joint

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trapeziectomy

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

No interventions assigned to this group

TMC-arthroplasty

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No