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

Medical University of Warsaw

Status: Not yet enrolling

Conditions: Thumb Osteoarthritis; Carpometacarpal Osteoarthritis; Rhizarthrosis

Treatments: Procedure: Joint alloplasty; Procedure: Trapeziectomy with suspensionplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04588961

WarsawMU/thumb

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control group

Active Comparator group

Description:

Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis

Treatment:

Procedure: Trapeziectomy with suspensionplasty

Study group

Active Comparator group

Description:

Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis

Treatment:

Procedure: Joint alloplasty