Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis
- Conditions
- Carpometacarpal OsteoarthritisRhizarthrosisThumb Osteoarthritis
- Interventions
- Procedure: Joint alloplastyProcedure: Trapeziectomy with suspensionplasty
- Registration Number
- NCT04588961
- Lead Sponsor
- Medical University of Warsaw
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Joint alloplasty Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis Control group Trapeziectomy with suspensionplasty Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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.
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
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
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
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)
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.
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
Trial Locations
- Locations (1)
Department of Othopedics and Rehabilitation, Medical University of Warsaw
🇵🇱Warszawa, Mazowieckie, Poland