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NCT Number: NCT02693600

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

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.

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Key information

Conditions

Trapeziometacarpal Osteoarthritis

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ligamentoplasty with partial trapeziectomy

Procedure

Ligamentoplasty with total trapeziectomy

Procedure

Primary outcomes

  1. 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

  1. Changes in pain score assessed with E.V.A Scale

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

    Assessment is performed by E.V.A Scale.

  2. Changes in range of motion

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

    Opposition, retropulsion and radial abduction were registered.

  3. Changes in Collapse of the first column of thumb using calibrated radiographic analysis

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

    To measure the collapse of the first column of thumb using calibrated radiographic analysis

  4. Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)

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

    Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 26, 2016
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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