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Completed

NCT Number: NCT05028426

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.

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Key information

Conditions

Arthroplasty Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier la Rochelle Ré Aunis

La Rochelle, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Patients With Early Complication

    Time frame: 3 months after surgery

    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.

Secondary outcomes

  1. Number of Patients With Late Complication

    Time frame: up to 28 months after surgery

    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.

  2. Length of Hospital Stay

    Time frame: up to 1 month after surgery

    the time between admission for an operation and discharge from the hospital

  3. Preoperative Knee Extension

    Time frame: up to 1 month before surgery

    Measure in degree of how much the knee straightens during consultation with surgeon

  4. Postoperative Knee Extension

    Time frame: At 3 months after surgery

    Measure in degree of how much the knee straightens during consultation with surgeon

  5. Preoperative Knee Flexion

    Time frame: up to 1 month before surgery

    Measure in degree of how much the knee bends during consultation with surgeon

  6. Postoperative Knee Flexion

    Time frame: At 3 months after surgery

    Measure in degree of how much the knee bends during consultation with surgeon

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 31, 2021
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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