Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study

NCT06305858 | Recruiting

• 1 other identifier: UKA - PFJ
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study. The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores. The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B. The population consists of 48 adult patients with gonarthrosis divided into two groups: 24 patients Group A experimental group: partial denture surgical procedure 24 patients Group B control group: total denture surgical procedure with patellar resurfacing

Conditions

Knee Disease

Outcome Measures

Primary Outcomes (1)

• Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B

  Evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B

  1 month after surgery

Study Arms (2)

Partial denture surgical procedure

EXPERIMENTAL

Procedure: Prosthetic Surgical Procedure

Total denture surgical procedure with patellar resurfacing

ACTIVE COMPARATOR

Procedure: Prosthetic Surgical Procedure

Interventions

Prosthetic Surgical Procedure PROCEDURE

The population consists of 48 patients divided into two groups: 24 patients Group A experimental group: partial denture surgical procedure 24 patients Group B control group: total denture surgical procedure with patellar resurfacing

Partial denture surgical procedure; Total denture surgical procedure with patellar resurfacing

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Grade 3-4 sec Kellgren-Lawrence medial gonarthrosis
• Patellar symptoms
• Primary gonarthrosis
• Patients with ligament integrity
• Age between 40 and 85 years inclusive
• Signing of the Informed Consent and consent to cooperate in all study procedures.

You may not qualify if:

• Cognitive impairment
• Psychiatric disorders
• Neuromuscular disorders
• Age \> 85 years and \<40 years
• Lateral gonarthrosis grade 4 sec Kellgren-Lawrence
• Secondary medial gonarthrosis
• Revisions
• Minors
• Pregnant women self-declaration

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Clinico San Siro

Milan, Italy

RECRUITING

Central Study Contacts

Elena Cittera

CONTACT

0283502224; elena.cittera@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IT (1)