Arthroplasty Complications
Conditions
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Early Complication | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | up to 1 month after surgery | the time between admission for an operation and discharge from the hospital |
| Preoperative Knee Extension | up to 1 month before surgery | Measure in degree of how much the knee straightens during consultation with surgeon |
| Number of Patients With Late Complication | 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. |
| Preoperative Knee Flexion | up to 1 month before surgery | Measure in degree of how much the knee bends during consultation with surgeon |
| Postoperative Knee Flexion | At 3 months after surgery | Measure in degree of how much the knee bends during consultation with surgeon |
| Postoperative Knee Extension | At 3 months after surgery | Measure in degree of how much the knee straightens during consultation with surgeon |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 455 |
Baseline characteristics
| Characteristic | Traditional Method of Care | Some Elements of a Fast-track Program | Full Enhanced Recovery Program | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 146 Participants | 103 Participants | 73 Participants | 322 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 29 Participants | 36 Participants | 133 Participants |
| Age, Continuous | 70 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 Participants | 16 Participants | 16 Participants | 61 Participants |
| American Society of Anesthesiology (ASA) score ASA score = 2 | 128 Participants | 87 Participants | 67 Participants | 282 Participants |
| American Society of Anesthesiology (ASA) score ASA score = 3 | 57 Participants | 29 Participants | 26 Participants | 112 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment France | 214 participants | 132 participants | 109 participants | 455 participants |
| Sex: Female, Male Female | 130 Participants | 77 Participants | 66 Participants | 273 Participants |
| Sex: Female, Male Male | 84 Participants | 55 Participants | 43 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 214 | 1 / 132 | 2 / 109 |
| other Total, other adverse events | 7 / 214 | 7 / 132 | 6 / 109 |
| serious Total, serious adverse events | 9 / 214 | 21 / 132 | 5 / 109 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Method of Care | Number of Patients With Early Complication | 9 Participants |
| Some Elements of a Fast-track Program | Number of Patients With Early Complication | 16 Participants |
| Full Enhanced Recovery Program | Number of Patients With Early Complication | 4 Participants |
Length of Hospital Stay
the time between admission for an operation and discharge from the hospital
Time frame: up to 1 month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Method of Care | Length of Hospital Stay | 9.5 days | Standard Deviation 2.7 |
| Some Elements of a Fast-track Program | Length of Hospital Stay | 5.6 days | Standard Deviation 2.4 |
| Full Enhanced Recovery Program | Length of Hospital Stay | 4.9 days | Standard Deviation 2.1 |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Method of Care | Number of Patients With Late Complication | 0 Participants |
| Some Elements of a Fast-track Program | Number of Patients With Late Complication | 5 Participants |
| Full Enhanced Recovery Program | Number of Patients With Late Complication | 1 Participants |
Postoperative Knee Extension
Measure in degree of how much the knee straightens during consultation with surgeon
Time frame: At 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Method of Care | Postoperative Knee Extension | 0.5 degree | Standard Deviation 2.1 |
| Some Elements of a Fast-track Program | Postoperative Knee Extension | 0.7 degree | Standard Deviation 2.8 |
| Full Enhanced Recovery Program | Postoperative Knee Extension | 0.8 degree | Standard Deviation 3.6 |
Postoperative Knee Flexion
Measure in degree of how much the knee bends during consultation with surgeon
Time frame: At 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Method of Care | Postoperative Knee Flexion | 114.5 degree | Standard Deviation 14.9 |
| Some Elements of a Fast-track Program | Postoperative Knee Flexion | 116.6 degree | Standard Deviation 14.4 |
| Full Enhanced Recovery Program | Postoperative Knee Flexion | 112.9 degree | Standard Deviation 16.1 |
Preoperative Knee Extension
Measure in degree of how much the knee straightens during consultation with surgeon
Time frame: up to 1 month before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Method of Care | Preoperative Knee Extension | 5 degree | Standard Deviation 8.2 |
| Some Elements of a Fast-track Program | Preoperative Knee Extension | 7.4 degree | Standard Deviation 7.4 |
| Full Enhanced Recovery Program | Preoperative Knee Extension | 4.8 degree | Standard Deviation 8 |
Preoperative Knee Flexion
Measure in degree of how much the knee bends during consultation with surgeon
Time frame: up to 1 month before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Method of Care | Preoperative Knee Flexion | 106.5 degree | Standard Deviation 13.3 |
| Some Elements of a Fast-track Program | Preoperative Knee Flexion | 107.0 degree | Standard Deviation 16.9 |
| Full Enhanced Recovery Program | Preoperative Knee Flexion | 108.3 degree | Standard Deviation 15.7 |