Trials Sponsors Conditions Drugs Pricing

Conditions

Trapeziometacarpal Osteoarthritis

Keywords

Total TrapeziectomyPartial TrapeziectomyLigamentoplasty

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Changes in pain score assessed with E.V.A Scale
Before, three Months and One year after surgery.
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 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 Arms (2)

Partial Trapeziectomy (PT)

ACTIVE COMPARATOR

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

Procedure: Ligamentoplasty with partial trapeziectomy

Total Trapeziectomy (TT)

ACTIVE COMPARATOR

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

Procedure: Ligamentoplasty with total trapeziectomy

Interventions

Ligamentoplasty with partial trapeziectomyProcedure

Partial Trapeziectomy (PT)

Ligamentoplasty with total trapeziectomyProcedure

Total Trapeziectomy (TT)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age45 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Sponsors & Collaborators

Corporacion Parc Tauli
Otherlead

Study Sites (1)

Hospital Universitario Parc Taulí

Sabadell, Barcelona, 08208, Spain

Study Officials

Ricard Sánchez-Flo, MD
Hospital Universitario Parc Taulí de Sabadell
STUDY DIRECTOR
Ferran Fillat-Gomà, MD
Hospital Universitario Parc Taulí de Sabadell
PRINCIPAL INVESTIGATOR

Enrollment

34 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, MSc

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 26, 2016

Study Start

September 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Partial Trapeziectomy (PT)

Total Trapeziectomy (TT)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Partial Trapeziectomy (PT)

Total Trapeziectomy (TT)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations