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

Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty: a Case Series of 50 Patients With Long-term Follow-up

: 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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Implant of metaphyseal sleeves in Total knee arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Milano, Milan, Italy, 20122
      • 2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Participation Criteria

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient whit osteoarthritis of the knee; Patients with osteoarthritis of the knee undergoing total knee replacement surgery with metaphyseal sleeves	Procedure: Implant of metaphyseal sleeves in Total knee arthroplasty; Implant of metaphyseal sleeves in Primary and revision TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Sleeve

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No