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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Implant of metaphyseal sleeves in Total knee arthroplasty

• Registration Number: NCT04995679
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Primary Completion: 2020-03-18
• Study Completion: 2020-07-15
• Study First Submitted: 2021-05-20
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-29
• Last Update Submitted: 2021-07-29
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient whit osteoarthritis of the knee	Implant of metaphyseal sleeves in Total knee arthroplasty	Patients with osteoarthritis of the knee undergoing total knee replacement surgery with metaphyseal sleeves

Primary Outcome Measures

Name	Time	Method
Evaluation of implant's survivorship	7 years	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

Name	Time	Method
Evaluation of Numerical Rating Scale (NRS)	7 years	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)	7 years	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)	7 years	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.

Trial Locations

Locations (1)

2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO; 🇮🇹 Milano, Milan, Italy