GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis
Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and successfully used in TMC OA surgery and therefore represents an acceptable alternative for avoiding possible donor-site morbidity. However, there are no randomised controlled trials (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared. Only with an RCT design it is possible to gain evidence about the advantages of one treatment method over another. The main objective of the study is the comparison between two surgical techniques for TMC OA: The resection interposition suspension arthroplasty using a part of the flexor carpi radialis tendon as interpositional material and using the GraftJacket as interpositional material.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 22, 2016
August 1, 2016
2.6 years
November 1, 2012
August 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery
preOP, 6 weeks, 3, 6, and 12months post OP
Secondary Outcomes (1)
Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.
preOP, 6 weeks, 3, 6, and 12months post OP
Other Outcomes (1)
Costs, Treatment satisfaction, objective and subjective function
preOP, 6 weeks, 3, 6, and 12months post OP
Study Arms (2)
GraftJacket
EXPERIMENTALGraftJAcket is used as interpositional material
Tendon Interposition
ACTIVE COMPARATORFlexor carpi radialis tendon is used as interpositional material
Interventions
Eligibility Criteria
You may qualify if:
- All adult patients diagnosed for TMC OA
- willing to participate and provide informed consent
You may not qualify if:
- Patients with rheumatoid arthritis,
- pregnant women,
- legal incompetent patients,
- persons with insufficient knowledge of the German language to complete the questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schulthess Klinik
Zurich, 8008, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel B Herren, MD, MHA
Schulthess Klinik
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- 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, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 22, 2016
Record last verified: 2016-08