Clinical trial NCT06654349: Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
Official title: Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthrosis of First Carpometacarpal Joint
Keywords: Trapeziectomy
Diary
TMC-arthroplasty
Osteoarthrosis
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 8 weeks
measure: Function
timeFrame: 8 weeks
measure: Quality of life (QoL)
timeFrame: 8 weeks
Secondary outcomes:
measure: Complications
timeFrame: 1 year
measure: Pain medication
timeFrame: 8 weeks
measure: PROMs - NRS
timeFrame: 1 year
measure: PROMs - PRWHE
timeFrame: 1 year
measure: PROMs - EQ5D
timeFrame: 1 year
measure: PROMs - HADS
timeFrame: 1 year
Other outcomes:
Locations:
city: Zoetermeer
country: Netherlands
facility: Reinier Haga Orthopedisch Centrum
state: Zuid-Holland
Study officials:
References: