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

NCT ID: NCT02693600

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-31

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.

Conditions

Trapeziometacarpal Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial Trapeziectomy (PT)

Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with with ligamentoplasty and partial trapeziectomy.

Group Type: ACTIVE_COMPARATOR

Ligamentoplasty with partial trapeziectomy

Intervention Type: PROCEDURE

Total Trapeziectomy (TT)

Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with ligamentoplasty and total trapeziectomy.

Group Type: ACTIVE_COMPARATOR

Ligamentoplasty with total trapeziectomy

Intervention Type: PROCEDURE

Interventions

Ligamentoplasty with partial trapeziectomy

Intervention Type: PROCEDURE

Ligamentoplasty with total trapeziectomy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Ferran Fillat Gomà

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricard Sánchez-Flo, MD

Role: STUDY_DIRECTOR

Hospital Universitario Parc Taulí de Sabadell

Ferran Fillat-Gomà, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Parc Taulí de Sabadell

Locations

Hospital Universitario Parc Taulí

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

CSPTCOT2014/01

Identifier Type: -

Identifier Source: org_study_id