Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small Implants (SMALLIMPL)

December 11, 2019 updated by: Istituto Ortopedico Galeazzi

Retrospective evaluation of:

Functional results Clinical results Survivorship of knee replacement performed with small implants, isolated or combined

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Retrospective evaluation of partial knee replacements (medial UNI, lateral UNI, patellofemoral replacement, combined UNI+ patellofemoral replacement, combined medial and lateral UNI) performed in the Joint Replacement Department of the IRCCS Istituto Ortopedico Galeazzi.

evaluation includes: clinical examination, functional results, survivorship at 1, 2, 5 , 10 and 15 years.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

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

  • Italy
      • Milano, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

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

Description

inclusion criteria:

  • patients receiving medial UNI or lateral UNI or patellofemoral replacement or combined UNI+ patellofemoral replacement or combined medial and lateral UNI
  • age > 18 years

exclusion criteria

  • patients receiving total knee replacement
  • patients having revision or a knee replacement

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: partial knee replacement
medial UNI, lateral UNI, patellofemoral replacement, combined UNI+ patellofemoral replacement, combined medial and lateral UNI
Procedure: PARTIAL KNEE REPLACEMENT
PARTIAL KNEE REPLACEMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KNEE SOCIETY SCORE
Time Frame: 2 years
total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100
2 years
KNEE SOCIETY SCORE
Time Frame: 5 years
total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100
5 years
KNEE SOCIETY SCORE
Time Frame: 10 years
total scale range: 0 (minimum)-100 (maximum); excellent results: 80-100
10 years

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 20, 2017

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SMALLIMPLANTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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