Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty

December 7, 2020 updated by: Central Hospital, Nancy, France

Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.

Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.

The functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.

Data is registered from the medical folder of every patient.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Meurthe ET Moselle
      • Nancy, Meurthe ET Moselle, France, 54000
        • Recruiting
        • Centre hospitalier régional universitaire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who have undergone a proximal interphalangeal joint arthroplasty with the Tactys prosthesis between january 2015 and january 2020 in the Chirugie de la main service in the Centre chirurgical Emile Gallé in Nancy

Description

Inclusion Criteria:

  • one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis
  • between january 2015 to january 2020
  • major
  • centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy

Exclusion Criteria:

  • minor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Results at short term follow up
Functional and Radiological results at short-term follow up (one year at least)
Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis
Results at middle term follow up
Functional and Radiological results at the last follow up of the patient (2 years at least)
Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion in degrees
Time Frame: minimal one year post-operative
measurement of range of motion in degrees
minimal one year post-operative
force in kilograms
Time Frame: minimal one year post-operative
measurement of force with jamar and pinch tests in kilograms
minimal one year post-operative
pain with the digital pain scale
Time Frame: minimal one year post-operative
measurement of pain with the digital pain scale to zero to ten
minimal one year post-operative
functional score with the Quick DASH
Time Frame: minimal one year post-operative
measurement of the quick-DASH functional score to zeo to hundred
minimal one year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
register the complication and their apparition in time
Time Frame: minimal one year post-operative
minimal one year post-operative
assess satisfaction
Time Frame: minimal one year post-operative
assess the patient's satisfaction : very satisfied, satisfied, moderate, not satisfied
minimal one year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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