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Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Primary Purpose

Trapeziometacarpal Osteoarthritis, Thumb Carpometacarpal Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Total Joint Arthroplasty
Trapeziectomy
Sponsored by
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trapeziometacarpal Osteoarthritis focused on measuring Osteoarthritis, Thumb, Total joint arthroplasty, Trapeziectomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women.
  • 40 years of age or more.
  • Symptomatic trapeziometacarpal osteoarthritis.
  • Eaton & Glickel stage 2 and 3.

Exclusion Criteria:

  • An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
  • Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
  • Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
  • Symptomatic carpal tunnel syndrome in same hand.
  • Symptomatic Quervain's tenosynovitis in same hand.
  • Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
  • Insufficient knowledge of Dutch language.

Sites / Locations

  • Isala HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Joint Arthroplasty

Trapeziectomy

Arm Description

Total Joint Arthroplasty

Trapeziectomy

Outcomes

Primary Outcome Measures

Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?

Secondary Outcome Measures

Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Michigan Hand Outcomes Questionnaire (MHOQ)
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Disabilities of Arm Shoulder and Hand (DASH)
Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
Grip strength
Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Thumb mobility
Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Complications
Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Return to work
Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?

Full Information

First Posted
July 29, 2014
Last Updated
September 2, 2016
Sponsor
Isala
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1. Study Identification

Unique Protocol Identification Number
NCT02204488
Brief Title
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3
Official Title
Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate. We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trapeziometacarpal Osteoarthritis, Thumb Carpometacarpal Osteoarthritis
Keywords
Osteoarthritis, Thumb, Total joint arthroplasty, Trapeziectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total Joint Arthroplasty
Arm Type
Active Comparator
Arm Description
Total Joint Arthroplasty
Arm Title
Trapeziectomy
Arm Type
Active Comparator
Arm Description
Trapeziectomy
Intervention Type
Procedure
Intervention Name(s)
Total Joint Arthroplasty
Intervention Description
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
Intervention Type
Procedure
Intervention Name(s)
Trapeziectomy
Intervention Description
Trapeziectomy
Primary Outcome Measure Information:
Title
Michigan Hand Outcomes Questionnaire (MHOQ)
Description
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Michigan Hand Outcomes Questionnaire (MHOQ)
Description
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Time Frame
5 years after surgery
Title
Michigan Hand Outcomes Questionnaire (MHOQ)
Description
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
Time Frame
1 and 5 years after surgery
Title
Disabilities of Arm Shoulder and Hand (DASH)
Description
Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
Time Frame
1 and 5 years after surgery
Title
Grip strength
Description
Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Time Frame
1 and 5 years after surgery
Title
Thumb mobility
Description
Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Time Frame
1 and 5 years after surgery
Title
Complications
Description
Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Time Frame
1 and 5 years after surgery
Title
Return to work
Description
Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
Time Frame
1 and 5 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women. 40 years of age or more. Symptomatic trapeziometacarpal osteoarthritis. Eaton & Glickel stage 2 and 3. Exclusion Criteria: An operation for trapeziometacarpal osteoarthritis on the same hand in the past. Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand. Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout. Symptomatic carpal tunnel syndrome in same hand. Symptomatic Quervain's tenosynovitis in same hand. Neurological or other disorders of the affected side that can influence postoperative rehabilitation. Insufficient knowledge of Dutch language.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon P. de Wildt, MD
Email
r.p.de.wildt@isala.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeroen H. van Uchelen, MD
Organizational Affiliation
Isala
Official's Role
Study Director
Facility Information:
Facility Name
Isala Hospital
City
Zwolle
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon P. de Wildt, MD
Email
r.p.de.wildt@isala.nl
First Name & Middle Initial & Last Name & Degree
Ramon P. de Wildt, MD

12. IPD Sharing Statement

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Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

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