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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Implant of metaphyseal sleeves in Total knee arthroplasty
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient whit osteoarthritis of the knee

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of implant's survivorship
A retrospective study was performed on patients who underwent TKA or Revision TKA using tibial and/or femoral metaphyseal sleeves to evaluate the implant's survivorship

Secondary Outcome Measures

Evaluation of Numerical Rating Scale (NRS)
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable
Evaluation of Western Ontario and Mc Master University (WOMAC)
The WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A sum of the scores for all three subscales gives a total WOMAC score
Evaluation of Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. Each of the 12 answers are assigned the previously defined number of points. They range from 1 = least difficult to 5 = most difficult. The 12 ratings are then added together to give a total score used to assess the patient. The possible total score ranges from 12 to 60 points. Here, a low score (e.g. 12 points) indicates good outcomes and vice versa.

Full Information

First Posted
May 20, 2021
Last Updated
July 29, 2021
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT04995679
Brief Title
Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty
Official Title
Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty: a Case Series of 50 Patients With Long-term Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient whit osteoarthritis of the knee
Arm Type
Other
Arm Description
Patients with osteoarthritis of the knee undergoing total knee replacement surgery with metaphyseal sleeves
Intervention Type
Procedure
Intervention Name(s)
Implant of metaphyseal sleeves in Total knee arthroplasty
Intervention Description
Implant of metaphyseal sleeves in Primary and revision TKA
Primary Outcome Measure Information:
Title
Evaluation of implant's survivorship
Description
A retrospective study was performed on patients who underwent TKA or Revision TKA using tibial and/or femoral metaphyseal sleeves to evaluate the implant's survivorship
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Evaluation of Numerical Rating Scale (NRS)
Description
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable
Time Frame
7 years
Title
Evaluation of Western Ontario and Mc Master University (WOMAC)
Description
The WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A sum of the scores for all three subscales gives a total WOMAC score
Time Frame
7 years
Title
Evaluation of Oxford Knee Score (OKS)
Description
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. Each of the 12 answers are assigned the previously defined number of points. They range from 1 = least difficult to 5 = most difficult. The 12 ratings are then added together to give a total score used to assess the patient. The possible total score ranges from 12 to 60 points. Here, a low score (e.g. 12 points) indicates good outcomes and vice versa.
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

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

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