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

January 4, 2021 updated by: Medical University of Warsaw

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 03-984
        • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
Time Frame: 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.
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)
Time Frame: 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.
at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire
Time Frame: 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.
at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - SF-36 (Short Form 36)
Time Frame: 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.
at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcome measures - VAS (Visual Analogue Score)
Time Frame: 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.
at baseline, 6 weeks and 6 months postoperatively
Changes in carpometacarpal, carpophalangeal and wrist range of motion
Time Frame: 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
at baseline, 6 weeks and 6 months postoperatively
Changes in usage of painkillers
Time Frame: 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
at baseline, 6 weeks and 6 months postoperatively
Operation related complications
Time Frame: at baseline, 6 weeks and 6 months postoperatively
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
Time Frame: at baseline, 6 weeks and 6 months postoperatively
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
Time Frame: 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
at baseline, 6 weeks and 6 months postoperatively
Radiological outcome on x-rays
Time Frame: 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
at baseline, 6 weeks and 6 months postoperatively
Muscle strength outcomes
Time Frame: at baseline, 6 weeks and 6 months postoperatively
Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC)
at baseline, 6 weeks and 6 months postoperatively
EMG measured bioelectrical potentials
Time Frame: 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
at baseline, 6 weeks and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Piotr Stępiński, MD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WarsawMU/thumb

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is still undecided because number of researchers included in the study is unknown

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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