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

Not Applicable

Completed

• Conditions: Trapeziometacarpal Osteoarthritis
• Interventions: Procedure: Ligamentoplasty with partial trapeziectomy; Procedure: Ligamentoplasty with total trapeziectomy

• Registration Number: NCT02693600
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-02-26
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial Trapeziectomy (PT)	Ligamentoplasty with partial trapeziectomy	Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with with ligamentoplasty and partial trapeziectomy.
Total Trapeziectomy (TT)	Ligamentoplasty with total trapeziectomy	Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with ligamentoplasty and total trapeziectomy.

Primary Outcome Measures

Name	Time	Method
Changes in the pollicis-lateral pinch strength	Before, three Months and One year after surgery.	In kilograms and measured with dynamometer.

Secondary Outcome Measures

Name	Time	Method
Changes in range of motion	Before, three Months and One year after surgery.	Opposition, retropulsion and radial abduction were registered.
Changes in Collapse of the first column of thumb using calibrated radiographic analysis	Before, three Months and One year after surgery.	To measure the collapse of the first column of thumb using calibrated radiographic analysis
Changes in pain score assessed with E.V.A Scale	Before, three Months and One year after surgery.	Assessment is performed by E.V.A Scale.
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.	Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).

Trial Locations

Locations (1)

Hospital Universitario Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain