NCT01724853

Brief Summary

The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

November 1, 2012

Last Update Submit

November 28, 2013

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Keywords

Carpometacarpalosteoarthritisoutcome measures

Outcome Measures

Primary Outcomes (1)

  • Michigan Hand Questionnaire - pain subscale

    12 months

Secondary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand Questionnaire

    12 months

Study Arms (2)

Surgery

OTHER

Preferred surgery

Procedure: Surgery

Conservative

OTHER

Conservative treatment

Other: Conservative

Interventions

SurgeryPROCEDURE

Resection suspension interposition arthroplasty or Arthrodesis

Surgery
ConservativeOTHER

Injection

Conservative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients diagnosed for TMC OA
  • signed informed consent

You may not qualify if:

  • rheumatoid arthritis,
  • legal incompetent patients,
  • patients already included in the study for the other hand,
  • insufficient knowledge of the German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Marks M, Audige L, Herren DB, Schindele S, Nelissen RG, Vliet Vlieland TP. Measurement properties of the German Michigan Hand Outcomes Questionnaire in patients with trapeziometacarpal osteoarthritis. Arthritis Care Res (Hoboken). 2014 Feb;66(2):245-52. doi: 10.1002/acr.22124.

    PMID: 23982906DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Surgical Procedures, OperativeConservative Treatment

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daniel Herren, Dr.

    Department of Handsurgery

    PRINCIPAL INVESTIGATOR

  • Miriam Marks, MSc.

    Department of Research and Development

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MHA

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 12, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

CH(1)