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

NCT02693600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-06-08

No results posted yet for this study

Summary

1. 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.
2. 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).
3. 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.

Conditions

  • Trapeziometacarpal Osteoarthritis

Interventions

PROCEDURE

Ligamentoplasty with partial trapeziectomy

PROCEDURE

Ligamentoplasty with total trapeziectomy

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Ricard Sánchez-Flo, MD · Hospital Universitario Parc Taulí de Sabadell

  • Ferran Fillat-Gomà, MD · Hospital Universitario Parc Taulí de Sabadell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-02-29
Completion
2017-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02693600 on ClinicalTrials.gov