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Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses

NCT04850300 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-03-04

No results posted yet for this study

Summary

Total knee arthroplasty (TKA) is currently the international standard for the treatment of degenerative and rheumatological diseases of the knee joint, as well as certain types of fractures. Although TKA is a procedure that has been shown to be effective in relieving pain and improving function in patients with osteoarthritis, approximately 20% of patients are dissatisfied with the results. Traditional methods of assessing the outcome after joint arthroplasty often focus on objective indicators of surgery and neglect the needs and opinions of patients. Because of this, this research project has the aim to know the effectiveness of two models of stabilization of total knee prostheses on the functionality achieved and perceived by the patient, as well as in the knee joint biomechanics during movement in activities of daily life. On the other hand, as a secondary objective, we propose to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers, and biomechanical functional evaluation that correlate and predict a correct evolution of patients with a knee replacement.

To carry out these objectives, 80 participants will be included with an indication to perform total knee joint replacement surgery. Participants will be randomized allocated into two groups: i. participants with a prosthesis with medial condylar stabilization ii. participants with a traditional prosthesis with central pivot stabilization. Participants will be evaluated at five-times: before surgery, immediate postsurgical, at 3 months of evolution, 6 months of evolution, and one year of evolution.

Conditions

  • Total Knee Arthroplasty

Interventions

PROCEDURE

Total knee prosthesis with medial condylar stabilization

Surgery will be done of Total knee prosthesis with medial condylar stabilization

PROCEDURE

Total knee prosthesis with central pivot stabilization

Surgery will be done of Total knee prosthesis with central pivot stabilization

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria INCLIVA

    collaborator INDUSTRY

  • University of Valencia

    lead OTHER

Principal Investigators

  • Antonio Silvestre Muñoz, PhD. · Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2023-07-28
Completion
2024-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850300 on ClinicalTrials.gov