An interventional study of Ligamentoplasty with partial trapeziectomy and Ligamentoplasty with total trapeziectomy in Trapeziometacarpal Osteoarthritis, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment
Introduction:
Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its collapse and thus preserving the stability of the carpus.
Objectives and Hypothesis:
Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with total trapeziectomy.
Main Objective:
To demonstrate using the dynamometer that the postoperative key pinch strength higher using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.
Secondary objectives:
To measure the collapse of the first column of thumb using calibrated radiographic analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire).
It is a single-center randomized trial, parallel-group, in which two types of surgical techniques (TT - TP) will be compared. Patients will be randomized in this two techniques will be followed for one year, in routine clinical practice.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with with ligamentoplasty and partial trapeziectomy.
Procedure: Ligamentoplasty with partial trapeziectomy
Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with ligamentoplasty and total trapeziectomy.
Procedure: Ligamentoplasty with total trapeziectomy
Changes in the pollicis-lateral pinch strength
In kilograms and measured with dynamometer.
Time frame: Before, three Months and One year after surgery.
Changes in pain score assessed with E.V.A Scale
Assessment is performed by E.V.A Scale.
Time frame: Before, three Months and One year after surgery.
Changes in range of motion
Opposition, retropulsion and radial abduction were registered.
Time frame: Before, three Months and One year after surgery.
Changes in Collapse of the first column of thumb using calibrated radiographic analysis
To measure the collapse of the first column of thumb using calibrated radiographic analysis
Time frame: Before, three Months and One year after surgery.
Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)
Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).
Time frame: Before, three Months and One year after surgery.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Corporacion Parc Tauli