Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReinier Haga Orthopedisch Centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Mentally disabled patients
Active infection
Current malignancy
Infiltration (corticoids < 3 months)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Trapeziectomy
Group B: TMC-arthroplasty
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
8 weeks3
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).
Time frame
8 weeksSecondary outcomes
1
Complications
Complications will be measured in the number of complications.
Time frame
1 year2
Pain medication
Pain medication will be measured with a diary during the first 8 weeks after surgery
Time frame
8 weeks3
PROMs - NRS
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.
Time frame
1 year4
PROMs - PRWHE
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov