NCT02204488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

July 29, 2014

Last Update Submit

September 2, 2016

Conditions

Trapeziometacarpal OsteoarthritisThumb Carpometacarpal Osteoarthritis

Keywords

OsteoarthritisThumbTotal joint arthroplastyTrapeziectomy

Outcome Measures

Primary Outcomes (1)

  • 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)?

    1 year after surgery

Secondary Outcomes (7)

  • Michigan Hand Outcomes Questionnaire (MHOQ)

    5 years after surgery

  • Michigan Hand Outcomes Questionnaire (MHOQ)

    1 and 5 years after surgery

  • Disabilities of Arm Shoulder and Hand (DASH)

    1 and 5 years after surgery

  • Grip strength

    1 and 5 years after surgery

  • Thumb mobility

    1 and 5 years after surgery

  • +2 more secondary outcomes

Study Arms (2)

Total Joint Arthroplasty

ACTIVE COMPARATOR

Total Joint Arthroplasty

Procedure: Total Joint Arthroplasty

Trapeziectomy

ACTIVE COMPARATOR

Trapeziectomy

Procedure: Trapeziectomy

Interventions

Total Joint ArthroplastyPROCEDURE

Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France

Total Joint Arthroplasty
TrapeziectomyPROCEDURE

Trapeziectomy

Trapeziectomy

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Hospital

Zwolle, Overijssel, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Jeroen H. van Uchelen, MD

    Isala

    STUDY DIRECTOR

Central Study Contacts

Ramon P. de Wildt, MD

CONTACT

r.p.de.wildt@isala.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 30, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2021

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

NL(1)