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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995679
• Other study ID #: Sleeve
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2021
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 15, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Implant of metaphyseal sleeves in Total knee arthroplasty
Implant of metaphyseal sleeves in Primary and revision TKA

Locations

Country	Name	City	State
Italy	2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO	Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 years
Secondary	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	7 years
Secondary	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	7 years
Secondary	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.	7 years