Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivien Fontaine, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier la Rochelle Ré Aunis | La Rochelle | France |
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.
Not provided
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.
The database will be made available by the study director upon request
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Method of Care | Patients managed according to the traditional care protocol without an enhanced recovery program |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Method of Care | Patients managed according to the traditional care protocol without an enhanced recovery program |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 months after surgery |
|
The post-surgery follow-up consultation took place 1 month after the operation. Depending on the clinical situation, further follow-up consultations took place up to 28 months after surgery.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Method of Care | Patients managed according to the traditional care protocol without an enhanced recovery program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivien Fontaine | Groupe Hospitalier de la Rochelle Ré Aunis | +33546455050 | recherche.clinique@ght-atlantique17.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2019 | Jul 4, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiology (ASA) score | The ASA score is a subjective assessment of a patient's overall health that is based on five classes (I to V).
| Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | up to 28 months after surgery |
|
|
|
| Secondary | Length of Hospital Stay | the time between admission for an operation and discharge from the hospital | Posted | Mean | Standard Deviation | days | up to 1 month after surgery |
|
|
|
| Secondary | Preoperative Knee Extension | Measure in degree of how much the knee straightens during consultation with surgeon | Posted | Mean | Standard Deviation | degree | up to 1 month before surgery |
|
|
|
| Secondary | Postoperative Knee Extension | Measure in degree of how much the knee straightens during consultation with surgeon | Posted | Mean | Standard Deviation | degree | At 3 months after surgery |
|
|
|
| Secondary | Preoperative Knee Flexion | Measure in degree of how much the knee bends during consultation with surgeon | Posted | Mean | Standard Deviation | degree | up to 1 month before surgery |
|
|
|
| Secondary | Postoperative Knee Flexion | Measure in degree of how much the knee bends during consultation with surgeon | Posted | Mean | Standard Deviation | degree | At 3 months after surgery |
|
|
|
| 6 |
| 214 |
| 9 |
| 214 |
| 7 |
| 214 |
| EG001 | 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. | 1 | 132 | 21 | 132 | 7 | 132 |
| EG002 | 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. | 2 | 109 | 5 | 109 | 6 | 109 |
| joint infection | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Fracture | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Joint instability | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Joint dislocation | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Stiffness | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Thromboembolic event | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Vascular injury | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Wound complication | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint prosthesis loosening | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Necrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematoma | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| ASA score = 2 |
|
| ASA score = 3 |
|