Carpometacarpal Osteoarthritis, Rhizarthrosis, Thumb Osteoarthritis
Conditions
Keywords
Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics
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.
Interventions
PROCEDURETrapeziectomy with suspensionplasty
Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
PROCEDUREJoint alloplasty
Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
Intervention model description
Patients would be assigned randomly to 2 different groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand) | at baseline, 6 weeks and 6 months postoperatively | To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation) | at baseline, 6 weeks and 6 months postoperatively | To measure wrist pain and disability in activities of daily living. Results range from 0 to 50, with lower scores corresponding to better outcomes. |
| Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire | at baseline, 6 weeks and 6 months postoperatively | 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. |
| Changes in patients reported outcomes - SF-36 (Short Form 36) | at baseline, 6 weeks and 6 months postoperatively | To explore differences in quality of life. Results range from 0 to 100, with higher scores corresponding to better outcomes. |
| Changes in patients reported outcome measures - VAS (Visual Analogue Score) | at baseline, 6 weeks and 6 months postoperatively | To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes. |
| Changes in usage of painkillers | at baseline, 6 weeks and 6 months postoperatively | 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 |
| Changes in carpometacarpal, carpophalangeal and wrist range of motion | at baseline, 6 weeks and 6 months postoperatively | 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 |
| Arthroplasty revision surgeries | at baseline, 6 weeks and 6 months postoperatively | To count and asses the reason of all revision surgeries that may occur during postoperative period |
| Biomechanical 3D motion analysis | at baseline, 6 weeks and 6 months postoperatively | Movements in whole range are measured using 3D motion analysis, using a special software. With more physiological movement patterns corresponding with better results |
| Radiological outcome on x-rays | at baseline, 6 weeks and 6 months postoperatively | 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 |
| Muscle strength outcomes | at baseline, 6 weeks and 6 months postoperatively | Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC) |
| EMG measured bioelectrical potentials | at baseline, 6 weeks and 6 months postoperatively | Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture |
| Operation related complications | at baseline, 6 weeks and 6 months postoperatively | To count and asses all complications that may occur during surgery and in postoperative period |
Countries
Poland
Contacts
Primary ContactPiotr Stępiński, MD
Backup ContactBartosz M. Maciąg, MD
Outcome results
None listed