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

Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications
• Intervention / Treatment: Procedure: Enhanced recovery program

Detailed Description

Enhanced recovery programs are an organizational evolution in surgical patient management, in which the patient becomes an actor of his or her own recovery. This multimodal approach aims at optimizing patient physiological and psychological states across preoperative, intraoperative and postoperative domains of care.

At la Rochelle hospital, the decision to take the step happened at the end of 2016. It was proposed by a young surgeon that have been trained on this new approach during his studies and who convinced the head of the surgery department of the benefits for the patients, the healthcare workers, and the institution. The transition took place in two stages, first operative and postoperative techniques were modified, and then preoperative education and counselling were added.

• Study Type: Observational
• Enrollment (Actual): 455

Contacts and Locations

Study Locations

• France
  • La Rochelle, France
    • Groupe Hospitalier La Rochelle Ré Aunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Late 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.	up to 28 months after surgery
Length of Hospital Stay	the time between admission for an operation and discharge from the hospital	up to 1 month after surgery
Preoperative Knee Extension	Measure in degree of how much the knee straightens during consultation with surgeon	up to 1 month before surgery
Postoperative Knee Extension	Measure in degree of how much the knee straightens during consultation with surgeon	At 3 months after surgery
Preoperative Knee Flexion	Measure in degree of how much the knee bends during consultation with surgeon	up to 1 month before surgery
Postoperative Knee Flexion	Measure in degree of how much the knee bends during consultation with surgeon	At 3 months after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Investigators: Study Director: Vivien Fontaine, MD, Groupe Hospitalier La Rochelle Ré Aunis

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2018/P01/266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Data will be made available with publication. Keywords are Arthroplasty, Replacement, Knee, Enhanced Recovery After Surgery. The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication. Medical Subject Headings (MESH) terms will be used to describe clinical data.

Methodology for will be provided in the publication. International standard unit will be used.

• IPD Sharing 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.
• IPD Sharing Access Criteria: The database will be made available by the study director upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No