- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080663
Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate
In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure converts the wrist in a simple hinged joint but allows us to preserve a certain range of motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis between the head of the capitate and the lunate fossa. The long-term follow-up of this procedure has always been a reason for concern. The investigators set up this retrospective study to evaluate the long-term results of the procedure in the investigators institution.
Also, the shape of the head of the capitate may play a role in the development of arthritis. A more round shape could distribute the forces more equally and thus prevent the progression of cartilage damage
The study hypothesis is:
- PRC preserves range of motion and force in the long term (more than 10 years postoperatively).
- A more round head of the capitate is associated with an increased risk of developing arthritis in the new joint.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We invite all patients who underwent a PRC at our institution with a follow-up of more than 10 years for review.
Questions
VAS pain in rest and during activity
- Pain is quantified as none, minimal (pain with strenuous activity), moderate (pain with daily activity), or severe (pain at rest).
- If pain, use of analgetics, splint, …
- quick DASH
- patient related wrist evaluation (PRWE) score. form-36 (SF-36) general health status outcome ?
- Satisfaction, do it again?
- Complications? Re-operations?
- Return to work after operation, which job (manual labor?) changed job due to wrist problems? Worker's compensation claims?
Clinical review
- grip force + other side to compare (Jamar Dynamometer)
- pinch grip + other side to compare
range of motion measurement:
- absolute and compared to other side
- flexion-extension, ulnar-radial deviation and prosupination
Radiography:
Standard anterioposterior and lateral wrist radiography performed to evaluate the onset or degree of arthritis.
o Radiocapitate arthrosis grading:
- None
- Minimal (joint space narrowing alone),
- Moderate (joint space narrowing with adjacent subchondral sclerosis)
- severe (bone collapse, erosion, or subchondral cyst formation)
- Oldest radiography of each patient was retrieved and the shape of the capitate evaluated.
- If available, a pre-operative MRI scan could also be interpreted. (Probably no MRI's available, but MRI gives a better indication of the shape of the capitate than plain X-ray).
- Review: documentation of intra-operative findings concerning capitate and lunate fossa.
Statistical analysis
- Student's t-test on the numerical data
- Wilcoxon signed- rank test on the visual analog scales
- Differences significant at p < .05. Two-tailed tests in all cases.
- Subgroups according to initial diagnosis
- Compare results with the initial follow-up to evaluate the prospective value of this follow-up moment.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospitals Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who underwent a Proximal row carpectomy
Exclusion Criteria:
- Bilateral procedure
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Proximal row carpectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quick DASH score
Time Frame: more than 10 year after operation
|
The Disability of Arm, Shoulder and Hand score is a standardised outcome measure for upper limb evaluation.
|
more than 10 year after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arthritis between capitate and lunate fossa
Time Frame: 10 years after operation
|
radiographic evaluation of arthritis in the wrist:
|
10 years after operation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of movement
Time Frame: 10 years after operation
|
clinical measurement with a goniometer of the flexion, extension, ulnar and radial deviation and pronation and supination + comparison to the other, uninvolved wrist
|
10 years after operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maarten Van Nuffel, M.D., Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- PRC Van Nuffel De Smet
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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