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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03763552
Other study ID # KEK-ZH ID 2017-02003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 30, 2018
Est. completion date December 31, 2018

Study information

Verified date May 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 31, 2018
Est. primary completion date August 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. Signed informed consent for participation in the study and for further use of collected data. Exclusion Criteria: 1. Missing Informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
arthroscopic wrist arthrodesis
Cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws

Locations

Country Name City State
Switzerland Olga Politikou Zürich Schweiz

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Wrist range of motion after surgery Extension , Flexion, Radial and ulnar deviation, Pronation , Supination 5 minutes
Secondary Hand strength after surgery 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
Secondary Pain assessment in weight bearing (Visual analogue scale, VAS) 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
Secondary Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire 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