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

NCT06654349 | Recruiting

• 2 other identifiers: OC-2024-001N24.085
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthrosis of First Carpometacarpal Joint

Keywords

Trapeziectomy; Diary; TMC-arthroplasty; Osteoarthrosis

Outcome Measures

Primary Outcomes (3)

• Pain

  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.

  8 weeks

• Function

  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.

  8 weeks

• Quality of life (QoL)

  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).

  8 weeks

Secondary Outcomes (6)

• Complications

  1 year

• Pain medication

  8 weeks

• PROMs - NRS

  1 year

• PROMs - PRWHE

  1 year

• PROMs - EQ5D

  1 year

Study Arms (2)

Trapeziectomy

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

TMC-arthroplasty

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive eligible subjects will be asked to participate and devided into either the Trapeziectomy cohort or the TMC-arthroplasty cohort, depending on the scheduled operative treatment for the osteoarthrosis of the first carpometacarpal joint.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead

Study Sites (1)

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725NA, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Rianne Oomen

CONTACT

+31792065595; Onderzoek@rhoc.nl

Nina Mathijssen

CONTACT

+31792065595; Onderzoek@rhoc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

NL (1)