- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906996
Proximal Row Carpectomy Versus Four Corner Fusion
Comparison of Subjective, Radiological and Functional Results After Proximal Row Carpectomy and Four Corner Fusion
There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two surgical procedures are used to treat a post-traumatic wrist osteoarthritis, especially after scaphoid non-union advanced collapse (SNAC) and scapholunate advanced collapse (SLAC): the proximal row carpectomy and the four corner fusion. Both surgical procedures are rescue operations. They are used to reduce pain and to maintain the mobility, compared to a complete stiffening of the wrist.
In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively and a lower complication rate, whereas the four corner fusion has a lower progression of radiocarpale osteoarthritis and a better grip strength.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- post-traumatic wrist osteoarthritis
- treated with a proximal row carpectomy or four corner fusion
- signed written informed consent
Exclusion Criteria:
- no knowledge of German
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
proximal row carpectomy
patients were treated with a proximal row carpectomy
|
excision of the scaphoid, lunate and triquetrum
|
|
four corner fusion
patients were treated with a four corner fusion
|
excision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion of the wrist
Time Frame: participants will be followed up by an expected average of 4.5 years
|
measurements of flexion/extension,supination/pronation and radial-/ulnarduction of the wrist
|
participants will be followed up by an expected average of 4.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication rate
Time Frame: participants will be followed up by an expected average of 4.5 years
|
Detection of complications of both surgical procedures
|
participants will be followed up by an expected average of 4.5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grip strength
Time Frame: participants will be followed up by an expected average of 4.5 years
|
measurement of grip strength
|
participants will be followed up by an expected average of 4.5 years
|
|
Patient-Rated Wirst Evaluation (PRWE)
Time Frame: participants will be followed up by an expected average of 4.5 years
|
Comparison of proximal row carpectomy and four corner fusion in respect to PRWE
|
participants will be followed up by an expected average of 4.5 years
|
|
Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: participants will be followed up by an expected average of 4.5 years
|
Comparison of proximal row carpectomy and four corner fusion in respect to MHQ
|
participants will be followed up by an expected average of 4.5 years
|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: participants will be followed up by an expected average of 4.5 years
|
Comparison of proximal row carpectomy and four corner fusion in rsespect to QuickDASH
|
participants will be followed up by an expected average of 4.5 years
|
|
Detection of radiological parameters
Time Frame: participants will be followed up by an expected average of 4.5 years
|
Detection of arthrosis fossa lunata, impingement and loosening
|
participants will be followed up by an expected average of 4.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel B Herren, Dr. med., Schulthess Klinik
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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