Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial

Conditions
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Carpometacarpal Osteoarthritis, Rhizarthrosis, Thumb Osteoarthritis

Intervention / Treatment
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* Procedure: Trapeziectomy with suspensionplasty
* Procedure: Joint alloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients would be assigned randomly to 2 different groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis | Procedure: Trapeziectomy with suspensionplasty<br>* Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon<br>|
| Active Comparator: Study group<br>Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis | Procedure: Joint alloplasty<br>* Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis<br>* Other names: Joint replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand) | To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation) | To measure wrist pain and disability in activities of daily living. Results range from 0 to 50, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | 
| Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire | To explore differences in higher levels of activity at work and social participation. Results range from 0 to 100, with higher scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | 
| Changes in patients reported outcomes - SF-36 (Short Form 36) | To explore differences in quality of life. Results range from 0 to 100, with higher scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | 
| Changes in patients reported outcome measures - VAS (Visual Analogue Score) | To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes. | at baseline, 6 weeks and 6 months postoperatively | 
| Changes in carpometacarpal, carpophalangeal and wrist range of motion | To explore differences in range of motion. This parameter will be measured with goniometer in flexion, extension, adduction and abduction in all thumb joints. Outcomes would be numers of degrees ranging from 0-360, with higher number corresponding with better outcomes | at baseline, 6 weeks and 6 months postoperatively | 
| Changes in usage of painkillers | To asses evolution of post-operative thumb pain. Dosage, frequency of utilisation and type of medicines will be measured in self-designed questionnaire, with lower dosage, lower frequency and less powerful medicines corresponding with better results | at baseline, 6 weeks and 6 months postoperatively | 
| Operation related complications | To count and asses all complications that may occur during surgery and in postoperative period | at baseline, 6 weeks and 6 months postoperatively | 
| Arthroplasty revision surgeries | To count and asses the reason of all revision surgeries that may occur during postoperative period | at baseline, 6 weeks and 6 months postoperatively | 
| Biomechanical 3D motion analysis | Movements in whole range are measured using 3D motion analysis, using a special software. With more physiological movement patterns corresponding with better results | at baseline, 6 weeks and 6 months postoperatively | 
| Radiological outcome on x-rays | To asses any changes in alignment of implants with would be measured with degrees (angles) with more degrees of change after operation corresponding with worse outcome | at baseline, 6 weeks and 6 months postoperatively | 
| Muscle strength outcomes | Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC) | at baseline, 6 weeks and 6 months postoperatively | 
| EMG measured bioelectrical potentials | Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture | at baseline, 6 weeks and 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics