Trial Outcomes & Findings for Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program (NCT NCT05028426)
NCT ID: NCT05028426
Last Updated: 2022-07-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
455 participants
Primary outcome timeframe
3 months after surgery
Results posted on
2022-07-07
Participant Flow
Participant milestones
| Measure |
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
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
214
|
132
|
109
|
|
Overall Study
COMPLETED
|
214
|
132
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=214 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=455 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=214 Participants
|
29 Participants
n=132 Participants
|
36 Participants
n=109 Participants
|
133 Participants
n=455 Participants
|
|
Age, Categorical
>=65 years
|
146 Participants
n=214 Participants
|
103 Participants
n=132 Participants
|
73 Participants
n=109 Participants
|
322 Participants
n=455 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 9 • n=214 Participants
|
72 years
STANDARD_DEVIATION 8.9 • n=132 Participants
|
70 years
STANDARD_DEVIATION 8.5 • n=109 Participants
|
70 years
STANDARD_DEVIATION 8.9 • n=455 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=214 Participants
|
77 Participants
n=132 Participants
|
66 Participants
n=109 Participants
|
273 Participants
n=455 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=214 Participants
|
55 Participants
n=132 Participants
|
43 Participants
n=109 Participants
|
182 Participants
n=455 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
214 participants
n=214 Participants
|
132 participants
n=132 Participants
|
109 participants
n=109 Participants
|
455 participants
n=455 Participants
|
|
American Society of Anesthesiology (ASA) score
ASA score = 1
|
29 Participants
n=214 Participants
|
16 Participants
n=132 Participants
|
16 Participants
n=109 Participants
|
61 Participants
n=455 Participants
|
|
American Society of Anesthesiology (ASA) score
ASA score = 2
|
128 Participants
n=214 Participants
|
87 Participants
n=132 Participants
|
67 Participants
n=109 Participants
|
282 Participants
n=455 Participants
|
|
American Society of Anesthesiology (ASA) score
ASA score = 3
|
57 Participants
n=214 Participants
|
29 Participants
n=132 Participants
|
26 Participants
n=109 Participants
|
112 Participants
n=455 Participants
|
PRIMARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Early Complication
|
9 Participants
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up 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.
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Late Complication
|
0 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 1 month after surgerythe time between admission for an operation and discharge from the hospital
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Length of Hospital Stay
|
9.5 days
Standard Deviation 2.7
|
5.6 days
Standard Deviation 2.4
|
4.9 days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: up to 1 month before surgeryMeasure in degree of how much the knee straightens during consultation with surgeon
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Preoperative Knee Extension
|
5 degree
Standard Deviation 8.2
|
7.4 degree
Standard Deviation 7.4
|
4.8 degree
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: At 3 months after surgeryMeasure in degree of how much the knee straightens during consultation with surgeon
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Postoperative Knee Extension
|
0.5 degree
Standard Deviation 2.1
|
0.7 degree
Standard Deviation 2.8
|
0.8 degree
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: up to 1 month before surgeryMeasure in degree of how much the knee bends during consultation with surgeon
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Preoperative Knee Flexion
|
106.5 degree
Standard Deviation 13.3
|
107.0 degree
Standard Deviation 16.9
|
108.3 degree
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: At 3 months after surgeryMeasure in degree of how much the knee bends during consultation with surgeon
Outcome measures
| Measure |
Traditional Method of Care
n=214 Participants
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 Participants
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.
|
Full Enhanced Recovery Program
n=109 Participants
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.
|
|---|---|---|---|
|
Postoperative Knee Flexion
|
114.5 degree
Standard Deviation 14.9
|
116.6 degree
Standard Deviation 14.4
|
112.9 degree
Standard Deviation 16.1
|
Adverse Events
Traditional Method of Care
Serious events: 9 serious events
Other events: 7 other events
Deaths: 6 deaths
Some Elements of a Fast-track Program
Serious events: 21 serious events
Other events: 7 other events
Deaths: 1 deaths
Full Enhanced Recovery Program
Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Traditional Method of Care
n=214 participants at risk
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 participants at risk
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.
|
Full Enhanced Recovery Program
n=109 participants at risk
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.
|
|---|---|---|---|
|
Surgical and medical procedures
Bleeding
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
joint infection
|
1.4%
3/214 • Number of events 3 • 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.
|
6.1%
8/132 • Number of events 8 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Fracture
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
Joint instability
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
Joint dislocation
|
0.47%
1/214 • Number of events 1 • 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.
|
0.00%
0/132 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Hospitalisation
|
0.93%
2/214 • Number of events 2 • 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.
|
5.3%
7/132 • Number of events 7 • 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.
|
2.8%
3/109 • Number of events 3 • 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.
|
|
Surgical and medical procedures
Stiffness
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
Thromboembolic event
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
Vascular injury
|
0.93%
2/214 • Number of events 2 • 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.
|
0.00%
0/132 • 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.
|
0.00%
0/109 • 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.
|
|
Surgical and medical procedures
Wound complication
|
0.47%
1/214 • Number of events 1 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
Other adverse events
| Measure |
Traditional Method of Care
n=214 participants at risk
Patients managed according to the traditional care protocol without an enhanced recovery program
|
Some Elements of a Fast-track Program
n=132 participants at risk
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.
|
Full Enhanced Recovery Program
n=109 participants at risk
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.
|
|---|---|---|---|
|
Surgical and medical procedures
Joint prosthesis loosening
|
0.47%
1/214 • Number of events 1 • 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.
|
0.00%
0/132 • 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.
|
0.00%
0/109 • 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.
|
|
Skin and subcutaneous tissue disorders
Necrosis
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
General disorders
Pain
|
2.3%
5/214 • Number of events 5 • 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.
|
1.5%
2/132 • Number of events 2 • 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.
|
1.8%
2/109 • Number of events 2 • 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.
|
|
Surgical and medical procedures
Haematoma
|
0.00%
0/214 • 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.
|
1.5%
2/132 • Number of events 2 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/214 • 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.
|
0.00%
0/132 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
General disorders
Fall
|
0.47%
1/214 • Number of events 1 • 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.
|
0.00%
0/132 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/214 • 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.
|
0.76%
1/132 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
|
General disorders
Hyperthermia
|
0.00%
0/214 • 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.
|
0.00%
0/132 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
Additional Information
Dr. Vivien Fontaine
Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +33546455050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place