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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028426
• Other study ID #: 2018/P01/266
• Status: Completed
• Start date: January 2015
• Est. completion date: October 2019

Study information

• Verified date: July 2022
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: October 2019
• Est. primary completion date: December 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier la Rochelle Ré Aunis	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of Hospital Stay	the time between admission for an operation and discharge from the hospital	up to 1 month after surgery
Secondary	Preoperative Knee Extension	Measure in degree of how much the knee straightens during consultation with surgeon	up to 1 month before surgery
Secondary	Postoperative Knee Extension	Measure in degree of how much the knee straightens during consultation with surgeon	At 3 months after surgery
Secondary	Preoperative Knee Flexion	Measure in degree of how much the knee bends during consultation with surgeon	up to 1 month before surgery
Secondary	Postoperative Knee Flexion	Measure in degree of how much the knee bends during consultation with surgeon	At 3 months after surgery