Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler

Study Overview
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Brief Summary
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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). Methodology: 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.

Official Title
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Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler

Conditions
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Trapeziometacarpal Osteoarthritis

Intervention / Treatment
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* Procedure: Ligamentoplasty with partial trapeziectomy
* Procedure: Ligamentoplasty with total trapeziectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Osteoarthritis in the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) with trapeziometacarpal joint pain, loss of function, that were included in surgical waiting list and have accepted under informed consent, including the study. Exclusion Criteria: Patients with osteoarthritis Eaton-Littler (stage IV). Patients with huge affection of trapezium subchondral cysts and poor quality of trabecular bone. Cognitive impairment. Old fracture with impairment of the same extremity. Rheumatic active illness. Patients who withdraw their informed consent, or in case of impossibility of opinion by clinical status, whose legal guardians or close relatives to withdraw their informed consent to participate in the study. Patients who for any reason not related to the indication needed discontinue study participation or impossible to carry out assessments under more than two follow-up visits. Patients in whom it is considered that participation in the clinical study can be a prejudice, the physician responsible for patient care opinion.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partial Trapeziectomy (PT)<br>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<br> <br> |
| Active Comparator: Total Trapeziectomy (TT)<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the pollicis-lateral pinch strength | In kilograms and measured with dynamometer. | Before, three Months and One year after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain score assessed with E.V.A Scale | Assessment is performed by E.V.A Scale. | Before, three Months and One year after surgery. | 
| Changes in range of motion | Opposition, retropulsion and radial abduction were registered. | 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 | 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). | Before, three Months and One year after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Trapeziectomy, Partial Trapeziectomy, Ligamentoplasty