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

Trapeziometacarpal Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693600
• Other study ID #: CSPTCOT2014/01
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: June 7, 2017
• Start date: September 2014
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Trapeziometacarpal Osteoarthritis

Intervention

Procedure:
• Ligamentoplasty with partial trapeziectomy

• Ligamentoplasty with total trapeziectomy

Locations

Country	Name	City	State
Spain	Hospital Universitario Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the pollicis-lateral pinch strength	In kilograms and measured with dynamometer.	Before, three Months and One year after surgery.
Secondary	Changes in pain score assessed with E.V.A Scale	Assessment is performed by E.V.A Scale.	Before, three Months and One year after surgery.
Secondary	Changes in range of motion	Opposition, retropulsion and radial abduction were registered.	Before, three Months and One year after surgery.
Secondary	Changes in Collapse of the first column of thumb using calibrated radiographic analysis	To measure the collapse of the first column of thumb using calibrated radiographic analysis	Before, three Months and One year after surgery.
Secondary	Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)	Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).	Before, three Months and One year after surgery.