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

Primary Purpose

Carpometacarpal Osteoarthritis, Rhizarthrosis, Thumb Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Trapeziectomy with suspensionplasty
Joint alloplasty
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpometacarpal Osteoarthritis focused on measuring Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Study group

Arm Description

Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis

Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis

Outcomes

Primary Outcome Measures

Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes.

Secondary Outcome Measures

Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)
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
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)
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)
To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes.
Changes in carpometacarpal, carpophalangeal and wrist range of motion
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 usage of painkillers
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
To count and asses all complications that may occur during surgery and in postoperative period
Arthroplasty revision surgeries
To count and asses the reason of all revision surgeries that may occur during postoperative period
Biomechanical 3D motion analysis
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
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
Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC)
EMG measured bioelectrical potentials
Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture

Full Information

First Posted
September 25, 2020
Last Updated
January 4, 2021
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT04588961
Brief Title
Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis
Official Title
Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpometacarpal Osteoarthritis, Rhizarthrosis, Thumb Osteoarthritis
Keywords
Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients would be assigned randomly to 2 different groups
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Trapeziectomy with suspensionplasty
Intervention Description
Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
Intervention Type
Procedure
Intervention Name(s)
Joint alloplasty
Other Intervention Name(s)
Joint replacement
Intervention Description
Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
Primary Outcome Measure Information:
Title
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
Description
To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes.
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)
Description
To measure wrist pain and disability in activities of daily living. Results range from 0 to 50, with lower scores corresponding to better outcomes.
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire
Description
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.
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Changes in patients reported outcomes - SF-36 (Short Form 36)
Description
To explore differences in quality of life. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Changes in patients reported outcome measures - VAS (Visual Analogue Score)
Description
To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes.
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Changes in carpometacarpal, carpophalangeal and wrist range of motion
Description
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
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Changes in usage of painkillers
Description
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
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Operation related complications
Description
To count and asses all complications that may occur during surgery and in postoperative period
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Arthroplasty revision surgeries
Description
To count and asses the reason of all revision surgeries that may occur during postoperative period
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Biomechanical 3D motion analysis
Description
Movements in whole range are measured using 3D motion analysis, using a special software. With more physiological movement patterns corresponding with better results
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Radiological outcome on x-rays
Description
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
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
Muscle strength outcomes
Description
Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC)
Time Frame
at baseline, 6 weeks and 6 months postoperatively
Title
EMG measured bioelectrical potentials
Description
Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture
Time Frame
at baseline, 6 weeks and 6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Stępiński, MD
Phone
607 190 402
Ext
+48
Email
piotr.stepinski01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bartosz M. Maciąg, MD
Phone
881 568 144
Ext
+48
Email
bartosz.maciag94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Stępiński, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Othopedics and Rehabilitation, Medical University of Warsaw
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-984
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is still undecided because number of researchers included in the study is unknown
Citations:
PubMed Identifier
16322609
Citation
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Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis

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