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OpenTrials
Completed

NCT Number: NCT04995679

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

: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant of metaphyseal sleeves in Total knee arthroplasty

Procedure

Implant of metaphyseal sleeves in Primary and revision TKA

Primary outcomes

  1. Evaluation of implant's survivorship

    Time frame: 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 outcomes

  1. Evaluation of Numerical Rating Scale (NRS)

    Time frame: 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

  2. Evaluation of Western Ontario and Mc Master University (WOMAC)

    Time frame: 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

  3. Evaluation of Oxford Knee Score (OKS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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