Dislocation of Midcarpal JointNCT03763552
Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes
An observational study of Dislocation of Midcarpal Joint, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dislocation of Midcarpal Joint
- What is being tested?
- arthroscopic wrist arthrodesis
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jul 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cases of arthroscopic mid-carpal wrist arthrodesis for mid-carpal arthritis, related to post-traumatic or degenerative carpal deformity, performed in our Division from January 2015 to October 2017 will be studied. The approximate number of participants will be 15. There will be no control group.
Who may be able to join
- 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.
Who cannot join
- 1. Missing Informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dislocation of Midcarpal Joint
- Being tested
- arthroscopic wrist arthrodesis
- Keywords
- arthroscopy, wrist osteoarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic wrist arthrodesisOther
Cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist range of motion after surgery
Extension , Flexion, Radial and ulnar deviation, Pronation , Supination
Measured: 5 minutes
Secondary outcomes (3)
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.
Measured: 2 minutes
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)
Measured: 1 minute
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start30 Jul 2018
- Primary completion13 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dislocation of Midcarpal JointStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763552
- Sponsor's protocol ID
- KEK-ZH ID 2017-02003
- Status last verified
- May 2023
- First submitted
- 10 Sep 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25290275del 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.
PubMed 23101536
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes
- ClinicalTrials.gov ID
- NCT03763552
- Acronym / sponsor ID
- KEK-ZH ID 2017-02003
- Conditions
- Dislocation of Midcarpal Joint
- Keywords
- arthroscopy, wrist osteoarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of arthroscopic mid-carpal wrist arthrodesis for mid-carpal arthritis, related to post-traumatic or degenerative carpal deformity, performed in our Division from January 2015 to October 2017 will be studied. The approximate number of participants will be 15. There will be no control group.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Missing Informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic wrist arthrodesisCases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws | Other | – |
Primary outcome
Wrist range of motion after surgery
Time frame: 5 minutes
Extension , Flexion, Radial and ulnar deviation, Pronation , Supination
3 secondary outcomes
Hand strength after surgery
Time frame: 2 minutes
Pain assessment in weight bearing (Visual analogue scale, VAS)
Time frame: 1 minute
Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Results publication: PubMed 25290275del 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.
- Results publication: PubMed 23101536del 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dislocation of Midcarpal Joint, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist range of motion after surgery (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.