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.

Study Overview

• Status: Completed
• Conditions: Trapeziometacarpal Osteoarthritis
• Intervention / Treatment: Procedure: Ligamentoplasty with partial trapeziectomy; Procedure: Ligamentoplasty with total trapeziectomy

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitario Parc Taulí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Ligamentoplasty with partial trapeziectomy
Active Comparator: 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.	Procedure: Ligamentoplasty with total trapeziectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Changes in range of motion	Opposition, retropulsion and radial abduction were registered.	Before, three Months and One year after surgery.
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.
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.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Study Director: Ricard Sánchez-Flo, MD, Hospital Universitario Parc Tauli de Sabadell

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Ligamentoplasty; Total Trapeziectomy; Partial Trapeziectomy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CSPTCOT2014/01