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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05028426
Enrollment
455
Registered
2021-08-31
Start date
2015-01-31
Completion date
2019-10-31
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications

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.

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.

Interventions

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

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Early Complication3 months after surgeryRecorded 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

MeasureTime frameDescription
Length of Hospital Stayup to 1 month after surgerythe time between admission for an operation and discharge from the hospital
Preoperative Knee Extensionup to 1 month before surgeryMeasure in degree of how much the knee straightens during consultation with surgeon
Number of Patients With Late Complicationup to 28 months after surgeryRecorded complications were Bleeding, Deep periprosthetic joint infection, Implant fracture, Instability, Patellofemoral dislocation, Readmission, Reoperation, Revision, Stiffness, Thromboembolic disease, Tibiofemoral dislocation, Vascular injury, Wound complication.
Preoperative Knee Flexionup to 1 month before surgeryMeasure in degree of how much the knee bends during consultation with surgeon
Postoperative Knee FlexionAt 3 months after surgeryMeasure in degree of how much the knee bends during consultation with surgeon
Postoperative Knee ExtensionAt 3 months after surgeryMeasure in degree of how much the knee straightens during consultation with surgeon

Countries

France

Participant flow

Participants by arm

ArmCount
Traditional Method of Care
Patients managed according to the traditional care protocol without an enhanced recovery program
214
Some Elements of a Fast-track Program
operative and postoperative techniques were modified according to a fast-track program 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.
132
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) 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.
109
Total455

Baseline characteristics

CharacteristicTraditional Method of CareSome Elements of a Fast-track ProgramFull Enhanced Recovery ProgramTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
146 Participants103 Participants73 Participants322 Participants
Age, Categorical
Between 18 and 65 years
68 Participants29 Participants36 Participants133 Participants
Age, Continuous70 years
STANDARD_DEVIATION 9
72 years
STANDARD_DEVIATION 8.9
70 years
STANDARD_DEVIATION 8.5
70 years
STANDARD_DEVIATION 8.9
American Society of Anesthesiology (ASA) score
ASA score = 1
29 Participants16 Participants16 Participants61 Participants
American Society of Anesthesiology (ASA) score
ASA score = 2
128 Participants87 Participants67 Participants282 Participants
American Society of Anesthesiology (ASA) score
ASA score = 3
57 Participants29 Participants26 Participants112 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
France
214 participants132 participants109 participants455 participants
Sex: Female, Male
Female
130 Participants77 Participants66 Participants273 Participants
Sex: Female, Male
Male
84 Participants55 Participants43 Participants182 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
6 / 2141 / 1322 / 109
other
Total, other adverse events
7 / 2147 / 1326 / 109
serious
Total, serious adverse events
9 / 21421 / 1325 / 109

Outcome results

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.

Time frame: 3 months after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Traditional Method of CareNumber of Patients With Early Complication9 Participants
Some Elements of a Fast-track ProgramNumber of Patients With Early Complication16 Participants
Full Enhanced Recovery ProgramNumber of Patients With Early Complication4 Participants
Secondary

Length of Hospital Stay

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

Time frame: up to 1 month after surgery

ArmMeasureValue (MEAN)Dispersion
Traditional Method of CareLength of Hospital Stay9.5 daysStandard Deviation 2.7
Some Elements of a Fast-track ProgramLength of Hospital Stay5.6 daysStandard Deviation 2.4
Full Enhanced Recovery ProgramLength of Hospital Stay4.9 daysStandard Deviation 2.1
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.

Time frame: up to 28 months after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Traditional Method of CareNumber of Patients With Late Complication0 Participants
Some Elements of a Fast-track ProgramNumber of Patients With Late Complication5 Participants
Full Enhanced Recovery ProgramNumber of Patients With Late Complication1 Participants
Secondary

Postoperative Knee Extension

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

Time frame: At 3 months after surgery

ArmMeasureValue (MEAN)Dispersion
Traditional Method of CarePostoperative Knee Extension0.5 degreeStandard Deviation 2.1
Some Elements of a Fast-track ProgramPostoperative Knee Extension0.7 degreeStandard Deviation 2.8
Full Enhanced Recovery ProgramPostoperative Knee Extension0.8 degreeStandard Deviation 3.6
Secondary

Postoperative Knee Flexion

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

Time frame: At 3 months after surgery

ArmMeasureValue (MEAN)Dispersion
Traditional Method of CarePostoperative Knee Flexion114.5 degreeStandard Deviation 14.9
Some Elements of a Fast-track ProgramPostoperative Knee Flexion116.6 degreeStandard Deviation 14.4
Full Enhanced Recovery ProgramPostoperative Knee Flexion112.9 degreeStandard Deviation 16.1
Secondary

Preoperative Knee Extension

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

Time frame: up to 1 month before surgery

ArmMeasureValue (MEAN)Dispersion
Traditional Method of CarePreoperative Knee Extension5 degreeStandard Deviation 8.2
Some Elements of a Fast-track ProgramPreoperative Knee Extension7.4 degreeStandard Deviation 7.4
Full Enhanced Recovery ProgramPreoperative Knee Extension4.8 degreeStandard Deviation 8
Secondary

Preoperative Knee Flexion

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

Time frame: up to 1 month before surgery

ArmMeasureValue (MEAN)Dispersion
Traditional Method of CarePreoperative Knee Flexion106.5 degreeStandard Deviation 13.3
Some Elements of a Fast-track ProgramPreoperative Knee Flexion107.0 degreeStandard Deviation 16.9
Full Enhanced Recovery ProgramPreoperative Knee Flexion108.3 degreeStandard Deviation 15.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026