Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Carpometacarpal Osteoarthritis
  • Rhizarthrosis
  • Thumb Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients would be assigned randomly to 2 different groupsMasking: Single (Outcomes Assessor)Masking Description: Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04588961
Collaborators
Not Provided
Investigators
Principal Investigator: Piotr St?pi?ski, MD Medical University of Warsaw