Clinical trial NCT04588961: Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis
Official title: Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpometacarpal Osteoarthritis
Rhizarthrosis
Thumb Osteoarthritis
Keywords: Thumb
Osteoarthritis
Trapeziectomy
Alloplasty
Biomechanics
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients would be assigned randomly to 2 different groups
Primary purpose: TREATMENT

Brief summary: This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty

Detailed description: Osteoarthritis of first carpometacarpal joint is the most common degenerative disease of upper limb. According to data available in literature, it affects about 30% of women and 6% of men at the age of 45. Increasing with age, it rises up to 90% in people by the age of 80. Due to more widely spread electronic devices in offices, at work, at home which requires usage of thumb, increase in numbers mentioned above is strongly probable. The main symptoms are: pain, loose of grip strength and loose of function. The latter is most important fact, since about 50% of hand function is possible only with healthy thumb.

In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists
* symptoms that do not respond to non-operative treatment for 8 weeks
* no counterindications for anaesthesia
* signed agreement for taking a part into trial

Exclusion Criteria:

* patient do not agree to take a part into study
* problems with communication with patient
* unstable cardiac disease
* reoperations
* previous surgical interventions in hand
* neuro-muscular diseases
* rheumatological background of disease
* diagnosed cervical spine disorders

Primary outcomes:
measure: Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
timeFrame: at baseline, 6 weeks and 6 months postoperatively
Secondary outcomes:
measure: Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Changes in patients reported outcomes - SF-36 (Short Form 36)
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Changes in patients reported outcome measures - VAS (Visual Analogue Score)
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Changes in carpometacarpal, carpophalangeal and wrist range of motion
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Changes in usage of painkillers
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Operation related complications
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Arthroplasty revision surgeries
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Biomechanical 3D motion analysis
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Radiological outcome on x-rays
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: Muscle strength outcomes
timeFrame: at baseline, 6 weeks and 6 months postoperatively
measure: EMG measured bioelectrical potentials
timeFrame: at baseline, 6 weeks and 6 months postoperatively
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Department of Othopedics and Rehabilitation, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Stępiński, MD
role: PRINCIPAL_INVESTIGATOR
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