Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty

NCT ID: NCT04995679

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-07-15

Brief Summary

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: Total knee revision arthroplasty is increasing in daily practice and will become more relevant in the years to come. Bone loss is a significant challenge in total knee arthroplasty (TKA) especially in revision procedures. Metaphyseal sleeves are widely used to bypass bone loss and improve stability. This study aims to report the results of primary and revision TKA (R-TKA) using metaphyseal sleeves.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient whit osteoarthritis of the knee

Patients with osteoarthritis of the knee undergoing total knee replacement surgery with metaphyseal sleeves

Group Type OTHER

Implant of metaphyseal sleeves in Total knee arthroplasty

Intervention Type PROCEDURE

Implant of metaphyseal sleeves in Primary and revision TKA

Interventions

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Implant of metaphyseal sleeves in Total knee arthroplasty

Implant of metaphyseal sleeves in Primary and revision TKA

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients were included if they were older than 18 years and underwent a primary or revision TKA using cement-less metaphyseal sleeves, performed by the same senior surgeon

Exclusion Criteria

* Patients were excluded from the final analysis if they did not have 18 months of minimum follow-up and if they were lost to the final control.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Pietro Randelli, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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Sleeve

Identifier Type: -

Identifier Source: org_study_id

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