Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program

NCT05028426 | Completed Results

• 1 other identifier: 2018/P01/266
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives are to describe the transition from traditional care to an enhanced recovery program for the management of total knee arthroplasty, and to evaluate the effect on patient outcomes.

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Early Complication

  Recorded complications were Bleeding, Deep periprosthetic joint infection, Implant fracture, Instability, Patellofemoral dislocation, Readmission, Reoperation, Revision, Stiffness, Thromboembolic disease, Tibiofemoral dislocation, Vascular injury, Wound complication.

  3 months after surgery

Secondary Outcomes (6)

• Number of Patients With Late Complication

  up to 28 months after surgery

• Length of Hospital Stay

  up to 1 month after surgery

• Preoperative Knee Extension

  up to 1 month before surgery

• Postoperative Knee Extension

  At 3 months after surgery

• Preoperative Knee Flexion

  up to 1 month before surgery

Study Arms (3)

Traditional method of care

Patients managed according to the traditional care protocol without an enhanced recovery program

Some elements of a fast-track program

operative and postoperative techniques were modified according to a fast-track program

Procedure: Enhanced recovery program

Full enhanced recovery program

Patients were managed in an enhanced recovery program (elements of the previous fast-track program were modified and preoperative education was added)

Procedure: Enhanced recovery program

Interventions

Enhanced recovery program PROCEDURE

Enhanced recovery programs are a multimodal approach to optimize patients' physiological and psychological states in the preoperative, intraoperative and postoperative care domains.

Full enhanced recovery program; Some elements of a fast-track program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were classified into three groups according to the type of care management they received: traditional method of care, some elements of a fast-track program during a transition period, and full enhanced recovery program.

You may qualify if:

• Patients operated on for posterior-stabilized total knee arthroplasty between January 2015 and December 2018
• unilateral arthroplasty
• a known address for mailing the study information letter

You may not qualify if:

• revision arthroplasty
• patients who refused to the use of their data

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead

Study Sites (1)

Groupe Hospitalier la Rochelle Ré Aunis

La Rochelle, France

Location

Results Point of Contact

• Title: Dr. Vivien Fontaine
• Organization: Groupe Hospitalier de la Rochelle Ré Aunis

recherche.clinique@ght-atlantique17.fr

+33546455050

Study Officials

• Vivien Fontaine, MD

  Groupe Hospitalier La Rochelle Ré Aunis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: October 1, 2019
• Last Updated: July 7, 2022
• Results First Posted: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available with publication (expected at the end of 2021 or beginning of 2022) and up to 15 years after the end of the study.
• Access Criteria: The database will be made available by the study director upon request

Locations

FR (1)