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

Recruiting

• Conditions: Arthrosis of First Carpometacarpal Joint

• Registration Number: NCT06654349
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-23
• Status Verified: 2025-05
• Study Start: 2025-05-15
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain	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.
Function	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.
Quality of life (QoL)	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 Outcome Measures

Name	Time	Method
Complications	1 year	Complications will be measured in the number of complications.
Pain medication	8 weeks	Pain medication will be measured with a diary during the first 8 weeks after surgery
PROMs - NRS	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.
PROMs - PRWHE	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.
PROMs - EQ5D	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.
PROMs - HADS	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).

Trial Locations

Locations (1)

Reinier Haga Orthopedisch Centrum; 🇳🇱 Zoetermeer, Zuid-Holland, Netherlands