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

NCT04995679 | Completed

• 1 other identifier: Sleeve
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of Numerical Rating Scale (NRS)

  7 years

• Evaluation of Western Ontario and Mc Master University (WOMAC)

  7 years

• Evaluation of Oxford Knee Score (OKS)

  7 years

Study Arms (1)

Patient whit osteoarthritis of the knee

OTHER

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

Procedure: Implant of metaphyseal sleeves in Total knee arthroplasty

Interventions

Implant of metaphyseal sleeves in Total knee arthroplasty PROCEDURE

Implant of metaphyseal sleeves in Primary and revision TKA

Patient whit osteoarthritis of the knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

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

Milan, Milan, 20122, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: August 9, 2021
• Study Start: July 15, 2019
• Primary Completion: March 18, 2020
• Study Completion: July 15, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-07

Locations

IT (1)