- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763552
Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes
All cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws from January 2015 to December 2017 will be reviewed.
The union rate and time to union will be recorded following the standard radiological postoperative control. Wrist assessments performed pre- and postoperative regarding strength, range of motion and pain will be analysed. Complications will be recorded as well.
Participants will be recruited for wrist assessment. They will be asked to fill out questionnaires about the functional result related to their quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Schweiz
-
Zürich, Schweiz, Switzerland, 8002
- Olga Politikou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All the patients suffered from traumatic or degenerative mid-carpal wrist arthritis or instability and treated surgically with arthroscopic midcarpal wrist arthrodesis in the Division of Plastic Surgery and Hand Surgery University Hospital Zürich from January 2015 to October 2017 will be included.
- Signed informed consent for participation in the study and for further use of collected data.
Exclusion Criteria:
1. Missing Informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wrist range of motion after surgery
Time Frame: 5 minutes
|
Extension , Flexion, Radial and ulnar deviation, Pronation , Supination
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand strength after surgery
Time Frame: 2 minutes
|
Strength measurement in kilos (Kg) with Jamar Dynamometer placed in Scale 2. Three consecutive trials will be executed, the best result (higher strength in kilos) will be registered.
|
2 minutes
|
|
Pain assessment in weight bearing (Visual analogue scale, VAS)
Time Frame: 1 minute
|
The patients will be asked to evaluate the pain in the wrist by full weight bearing, according to visual analogue scale (VAS 0-10, 0 means no pain, 10 means maximum pain)
|
1 minute
|
|
Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire
Time Frame: 5 minutes
|
This questionnaire asks about patient's symptoms as well as their ability to perform certain activities in the last week. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). The response to the first 30 items of the DASH are added to form the raw, or actual, score. A minimum score is 30; a maximum is 150.The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability. The maximum score of the second section is 20 with a minimum of 4. The range of scores is therefore 16. This score is also transformed to a zero-to-100 scale with lower scores reflecting minimal disability, and higher scores reflecting more disability. |
5 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- del Pinal F, Tandioy-Delgado F. (Dry) arthroscopic partial wrist arthrodesis: tips and tricks. Handchir Mikrochir Plast Chir. 2014 Oct;46(5):300-6. doi: 10.1055/s-0034-1387707. Epub 2014 Oct 7.
- del Pinal F, Klausmeyer M, Thams C, Moraleda E, Galindo C. Early experience with (dry) arthroscopic 4-corner arthrodesis: from a 4-hour operation to a tourniquet time. J Hand Surg Am. 2012 Nov;37(11):2389-99. doi: 10.1016/j.jhsa.2012.08.026.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH ID 2017-02003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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