Outcomes of Treatment for Trapeziometacarpal Osteoarthritis (RASSH)

This study has been completed.
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01724853
First received: November 1, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Procedure: Surgery
Other: Conservative

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Outcomes of Treatment for Trapeziometacarpal Osteoarthritis Using a Comprehensive Core Set.

Resource links provided by NLM:


Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • Michigan Hand Questionnaire - pain subscale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disabilities of the Arm, Shoulder and Hand Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery
Preferred surgery
Procedure: Surgery
Resection suspension interposition arthroplasty or Arthrodesis
Conservative
Conservative treatment
Other: Conservative
Injection

Detailed Description:

Hand osteoarthritis is a frequent condition in the middle-aged and elderly population with a prevalence of up to 76%. After the distal interphalangeal joints, the trapeziometacarpal joints are the most affected joints of the hand. Symptoms such as pain, stiffness, deformity, loss of grip strength, as well as reduction of joint mobility, are affecting the overall hand function and patients' quality of life. Numerous studies have evaluated different surgical and conservative interventions for treating patients with trapeziometacarpal osteoarthritis (TMC OA) with both interventions found to be effective in reducing pain and increasing function. To date, there is only little evidence about the characteristics and outcomes of patients who receive a conservative or a surgical treatment for TMC OA. The analysis should focus on which factors contribute to either a conservative or a surgical treatment, and if these patients differ regarding personal or health-related factors. Furthermore, no data about the economic consequences of a resection interposition suspension arthroplasty are available which highlights the need for a financial analysis of this procedure with respect to the benefit for the patient and cost bearers.

Besides objective parameters, such as strength and range of motion, the evaluation of patient satisfaction as well as the fulfilment of preoperative expectation is becoming increasingly important as outcome measures. However, there is no standardized instrument available for measuring satisfaction, expectations and their fulfillment for TMC OA patients.

For measuring outcomes of OA, a core set for outcome measures for OA trials (hip, knee, hand) was developed at the OMERACT III conference. It comprised of the assessment of pain, physical function, patients' global condition and joint imaging. Furthermore, the evaluation of quality of life is recommended, but the specific items of this core set for TMC OA patients still remain to be defined.

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.

In order to achieve these objectives, a prospective cohort study including patients with TMC OA will be conducted, regardless of if they will have surgery or not. A total of 100 surgically treated patients will be analysed during a one-year inclusion period and all conservatively treated patients will also be analysed during the same time. Follow up examinations will take place at 3, 6 and 12 months for all patients using a standardized set of objective as well as subjective outcome measurements including the MHQ.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • rheumatoid arthritis,
  • legal incompetent patients,
  • patients already included in the study for the other hand,
  • insufficient knowledge of the German language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724853

Locations
Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Leiden University Medical Center
Investigators
Principal Investigator: Daniel Herren, Dr. Department of Handsurgery
Study Chair: Miriam Marks, MSc. Department of Research and Development
  More Information

No publications provided by Schulthess Klinik

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Herren, MD, MHA, Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01724853     History of Changes
Other Study ID Numbers: RASSH01
Study First Received: November 1, 2012
Last Updated: November 28, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Schulthess Klinik:
Carpometacarpal
osteoarthritis
outcome measures

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014