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

NCT02693600 | Completed

• 1 other identifier: CSPTCOT2014/01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Introduction:
2. 2.Objectives and Hypothesis:
3. 3.Methodology:

Conditions

Trapeziometacarpal Osteoarthritis

Keywords

Total Trapeziectomy; Partial Trapeziectomy; Ligamentoplasty

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 trapeziectomy PROCEDURE

Partial Trapeziectomy (PT)

Ligamentoplasty with total trapeziectomy PROCEDURE

Total Trapeziectomy (TT)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitario Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

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

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 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

ES (1)