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Clinical Trials/NCT02693600
NCT02693600
Completed
Not Applicable

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

Corporacion Parc Tauli1 site in 1 country34 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trapeziometacarpal Osteoarthritis
Sponsor
Corporacion Parc Tauli
Enrollment
34
Locations
1
Primary Endpoint
Changes in the pollicis-lateral pinch strength
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
March 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Ferran Fillat Gomà

MD, MSc

Corporacion Parc Tauli

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in the pollicis-lateral pinch strength

Time Frame: Before, three Months and One year after surgery.

In kilograms and measured with dynamometer.

Secondary Outcomes

  • Changes in range of motion(Before, three Months and One year after surgery.)
  • Changes in Collapse of the first column of thumb using calibrated radiographic analysis(Before, three Months and One year after surgery.)
  • Changes in pain score assessed with E.V.A Scale(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)(Before, three Months and One year after surgery.)

Study Sites (1)

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