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NCT Number: NCT06654349

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

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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Key information

Conditions

Arthrosis of First Carpometacarpal Joint Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain

    Time frame: 8 weeks

    Pain will be measured each day in a diary for the first 8 weeks after surgery with the Numeric Rating Scale for Pain (NRS), which is a scale ranging from zero to ten on which patients can score their pain. It is a widely used instrument in varying populations due to its ease of administration and clinical relevance to the subject.

  2. Function

    Time frame: 8 weeks

    Function will be measured each week in a diary for the first 8 weeks after surgery with the The Patient-Related Wrist/Hand Evaluation (PRWHE), which is a 15-item questionnaire concerning pain and function. Subjects are able to rate their pain and disabilities from zero to ten.

  3. Quality of life (QoL)

    Time frame: 8 weeks

    QoL will be measured twice a week in a diary for the first 8 weeks after surgery with the EQ-5D, which is a general health-related quality-of-life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality of life adjusted life years (QALY).

Secondary outcomes

  1. Complications

    Time frame: 1 year

    Complications will be measured in the number of complications.

  2. Pain medication

    Time frame: 8 weeks

    Pain medication will be measured with a diary during the first 8 weeks after surgery

  3. PROMs - NRS

    Time frame: 1 year

    Patient-related outcome measurements (PROMs) will be measured with the NRS as part of the standard care. Numeric Rating Scale for Pain (NRS) is a scale ranging from zero to ten on which patients can score their pain. It is a widely used instrument in varying populations due to its ease of administration and clinical relevance to the subject.

  4. PROMs - PRWHE

    Time frame: 1 year

    Patient-related outcome measurements (PROMs) will be measured with the PRWHE as part of the standard care. The Patient-Related Wrist/Hand Evaluation (PRWHE) is a 15-item questionnaire concerning pain and function. Subjects are able to rate their pain and disabilities from zero to ten.

  5. PROMs - EQ5D

    Time frame: 1 year

    Patient-related outcome measurements (PROMs) will be measured with the EQ5D as part of the standard care. EQ-5D is a general health-related quality-of-life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality of life adjusted life years (QALY). It has been translated into Dutch and validated in different populations.

  6. PROMs - HADS

    Time frame: 1 year

    Patient-related outcome measurements (PROMs) will be measured with the HADS as part of the standard care. The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire concerning the mental state of the subject (i.e. anxiety and depression).

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Mathijssen

CONTACT

[email protected]

+31792065595

Rianne Oomen

CONTACT

[email protected]

+31792065595

Sponsors and collaborators

Lead sponsor

Reinier Haga Orthopedisch Centrum

Other

Registry information

Acronym: THUMB Diary

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 23, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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