Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
Conditions: Arthroplasty Complications
Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

 
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Single-center retrospective study on safety of total knee 
replacement surgery before and after the implementation 
of enhanced recovery program 
 
RRAC-RA 
2018/P01/226  
 
 
OBSERVATIONAL STUDY (research on retrospective data) 
 
 
 
 
 
 
 
Study director: 
Dr.Fontaine Vivien 
Orthopaedic surgery department 
Groupe Hospitalier de la Rochelle Ré Aunis 
 
 
 
 
 
 
 
 
 
This protocol was designed and written from version 3.0 of 01/02/2017 
of the GIRCI SOHO model protocol 

 
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CONTENTS 
1. 
SUMMARY OF THE RESEARCH 
3 
2. 
SCIENTIFIC JUSTIFICATION 
4 
3. 
OBJECTIVES 
4 
3.1. 
MAIN OBJECTIVE 
4 
3.2. 
SECONDARY OBJECTIVES 
4 
4. 
RESEARCH DESIGN 
5 
5. 
ELIGIBILITY CRITERIA 
5 
5.1. 
INCLUSION CRITERIA 
5 
5.2. 
EXCLUSION CRITERIA 
5 
5.3. 
FEASIBILITY AND RECRUITMENT PROCEDURES 
5 
6. 
RESEARCH STRATEGY(IES)/ PROCEDURE(S) 
5 
7. 
CONDUCTING THE RESEARCH 
6 
7.1. 
THE RESEARCH SCHEDULE 
6 
7.2. 
INFORMATION OF THE PERSONS CONCERNED 
6 
8. 
STATISTICAL ASPECTS 
6 
8.1. 
CALCULATION OF STUDY SIZE 
6 
8.2. 
STATISTICAL METHODS EMPLOYED 
7 
9. 
RIGHTS OF ACCESS TO DATA AND SOURCE DOCUMENTS 
7 
9.1. 
ACCESS TO DATA 
7 
9.2. 
SOURCE DATA 
7 
9.3. 
DATA CONFIDENTIALITY 
7 
10. 
ETHICAL AND REGULATORY CONSIDERATIONS 
8 
11. 
RULES FOR PUBLICATION 
8 
11.1. 
SCIENTIFIC COMMUNICATIONS 
8 
11.2. 
COMMUNICATION OF RESULTS TO PATIENTS 
8 
11.3. 
TRANSFER OF DATA 
8 
BIBLIOGRAPHIC REFERENCES 
9 
 
 

 
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1. SUMMARY OF THE RESEARCH 
Title of the study 
Single-center retrospective study on safety of total knee replacement surgery before 
and after the implementation of enhanced recovery program 
Sponsor 
 
Groupe Hospitalier de la Rochelle Ré Aunis 
NCT number 
NCT05028426 
PI 
Dr Fontaine Vivien 
Primary and secondary 
objectives 
The objectives are to compare the number of adverse events at 1 month, the number 
of thromboembolic events, the average length of stay and the improvement of 
mobility before and after the implementation of rapid rehabilitation protocols after 
surgery 
Methodology of reference 
(in France) 
 
 MR-004     
  MR-005     
  MR-006  
Data sources 
   Medical records 
  Survey / Cohort / Register including data from the national health data system 
  Medicalization Program of Information Systems 
  Other source of Data 
 
Study population 
 
Patients over 18 years of age treated between 2015 and 2018 by the Orthopaedic 
Surgery and Traumatology Department of the Groupe Hospitalier de la Rochelle Ré 
Aunis for total knee replacement  
 
Background 
 
 
Enhanced Recovery After Surgery (ERAS) is a management method that aims to 
allow the patient to recover as quickly as possible their physical and mental 
capacities. It was initially developed for colon surgery and has recently been 
extended to orthopaedic surgery protocols. 
Contexte of the study 
 
 
This innovative method has been practiced by the Orthopaedic Surgery and 
Traumatology Department of the La Rochelle Ré Aunis Hospital Group since 
January 2017. 
Methodology 
 
Single center retrospective study 
Statistical analysis plan 
Epidemiological analysis : 
- 
Description of Patients classified into three groups according to the type of 
care management they received: traditional care, some elements of a fast-
track program during a transition period, and full enhanced recovery 
program. 
- 
Using means +/- standard deviations, counts, and percentages to describe 
continuous and categorical variables, respectively 
Comparative analysis of the three groups : 
- 
Normal distributions will be verified and T-test or Mann-Whitney tests will 
be used to compare continuous data of independent samples where 
appropriate.  
- 
Chi-square test of homogeneity will be used for categorical variables.  
- 
An alpha level of 0.05 will be used for all statistical tests.  
Justification of the public 
interest character of the 
study 
Evaluation of the effectiveness and safety of a recent management protocol 
Timetable for the study 
and provisional schedule 
for communicating the 
results 
September 2019: drafting of the information leaflet, the protocol and the CRF 
From October 2019 to June 2020 : data collection 
End of 2020 : exploitation of the results and writing of a report/scientific manuscript 
 

 
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2.  SCIENTIFIC JUSTIFICATION 
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. First described by Kehlet[1], these programs have been gradually modified and used for many surgery 
specialties, including the perioperative management of hip and knee replacements[2]. Convincing results 
for the benefit of the patients have been achieved in the reduction of perioperative complications, shorter 
hospital stays, and some improvements in quality of life (rapid restoration of physical and mental 
capacities)[3]. These programs also contributes to optimizing the production of care in light of human and 
material constraints, as they participate in 1) limiting the presence of patients in hospital by reducing the 
length of stay ; 2) a better control of the organization, with a better responsiveness to new challenges, like 
infection ; and 3) possible increase in the number of patients treated, which will be necessary according to 
various projections[4, 5].  
Despite the proven benefits and numerous publications on enhanced recovery programs for total knee 
arthroplasty, physicians are still faced with the knowing-doing gap of translating the scientific data into 
daily clinical practice[6, 7].  
In our center, 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. Our hypothesis was that the shift from a traditional method of care to 
an enhanced recovery program can be implemented in a secondary-care hospital while ensuring the same 
safety and effectiveness for patients. 
3. OBJECTIVES 
3.1. Main objective 
The main objective is to measure early complication rate after total knee arthroplasty. 
It will be determined by the number of patients with complication detected within 3 months after surgery. 
3.2. Secondary objectives 
Secondary objectives are to measure: 
- 
Late complication rate (within 2 years after surgery) 
- 
Length of Hospital Stay 
- 
Preoperative Knee Extension 
- 
Postoperative Knee Extension 
- 
Preoperative Knee Flexion 
- 
Postoperative Knee Flexion 

 
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4. RESEARCH DESIGN 
This is a retrospective single-center cohort study. 
5. ELIGIBILITY CRITERIA 
5.1. 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 
5.2. Exclusion criteria 
- 
revision arthroplasty 
- 
patients who refused to the use of their data 
5.3. Feasibility and recruitment procedures  
Perioperative arthroplasty data will be collected from medical records.  
Five orthopedic surgeons performed total knee replacements.  
The inclusion period last from January 2015 to December 2018. 
6. RESEARCH STRATEGY(IES)/ PROCEDURE(S) 
Three phases: 
 
Phase 1 
The traditional care consisted of patients attending a surgical consultation during which the date of the 
operation was scheduled, followed by a pre-operative anesthesia consultation. Patients at risk of postoperative 
nausea and vomiting were screened and given multimodal prophylaxis and treatment. In case of anemia, 
erythropoietin was injected preoperatively[8]. Tranexamic acid was given by intravenous injection to reduce 
perioperative blood loss[9]. Patients received antimicrobial and antithrombotic prophylaxis treatment. 
Normal body temperature was maintained perioperatively[10]. During surgery, a femoral nerve block was 
placed for postoperative pain management. At the end of the operation, one or two drains were put in place 
to evacuate the blood and avoid post-operative hematomas. A Zimmer knee brace was used to immobilize 
the knee. Postoperative analgesia was provided by the self-controlled administration of local anesthetics via 
the femoral nerve catheter, and supplemented by systemic analgesics (paracetamol, oxycodone, nonsteroidal 

 
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anti-inflammatory drugs in the absence of contraindications). The first mobilization took place with the 
orthosis at day one or day two after surgery.  
 
Phase 2 
By the end of 2016, several operative and post-operative modifications were set up. Femoral nerve block was 
replaced by adductor canal block in combination with local infiltration analgesia[11], which has been shown 
to provide equivalent analgesia, while preserving quadriceps motor strength[12]. Zimmer Knee Splints was 
replaced by compressive cryotherapy knee brace for pain and bleeding management[13]. Only, one drain was 
used to evacuate the blood and avoid post-operative hematomas. The first mobilization happened at day zero, 
assisted by an Artromot[14].  
 
Phase 3 
To complete this program, from 2018 onwards, educational therapy with a nurse has been added. Patients 
were more comprehensively informed about the global care pathway. If necessary, counselling to assist with 
smoking cessation and addiction[15] could be offered in order to reduce risk of postoperative complications. 
Nutritional care could be set up on demand. If patients wished to be discharged to a rehabilitation center, the 
demand for beds was anticipated in order to reduce hospital waiting times. Operative and post-operative 
management was the same as before, except that draining was not systematic as it has not been used in well-
documented hip and knee enhanced recovery programs, with no increase in complications[11]. 
7. CONDUCTING THE RESEARCH 
7.1. The research schedule 
Eligible patients are those who underwent total knee arthroplasty from January 2015 to December 2018. 
7.2. Information of the persons concerned 
The doctor invites the patient to participate in this research and will inform him/her of: 
- the objective, 
- the digital processing of data concerning the patient that will be collected during this research and 
will also specify the patient’s rights of access, opposition and rectification to these data. 
8. STATISTICAL ASPECTS 
8.1. Calculation of study size 
According to the hospital information system, 470 patients were taken care for total knee arthroplasty surgery 
over the study period. 

 
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8.2. Statistical methods employed 
Patients will be classified into three groups according to the type of care management they received: Phase 1, 
2 or 3.  
Means +/- standard deviations, counts, and percentages will be used to describe continuous and categorical 
variables, respectively.  
Normal distributions will be verified and T-test or Mann-Whitney tests will be used to compare continuous 
data of independent samples where appropriate.  
Chi-square test of homogeneity will be for categorical variables.  
An alpha level of 0.05 will define statistical significance.  
XLSTAT (Addinsoft) will be used for statistical analysis. 
9. RIGHTS OF ACCESS TO DATA AND SOURCE DOCUMENTS 
9.1. Access to data 
Agreeing to participate in the protocol implies that the people who carry out the research will make the 
documents and personal data that are strictly necessary for the monitoring, quality control and auditing of the 
research, available in accordance with the laws and regulations in force. 
9.2. Source data 
All information contained in original documents, or in authenticated copies of these documents, relating to 
clinical examinations, observations or other activities conducted as part of a research study and necessary for 
the reconstitution and evaluation of the research. The documents in which the source data are saved are called 
the source documents. 
9.3. Data confidentiality 
In accordance with the legislative provisions in force, persons having direct access to source data will take 
all the necessary precautions to ensure the confidentiality of information relating to research, to participants, 
especially as regards their identity and the results obtained. These people, like the people who direct and 
monitor the research, are subject to professional secrecy. 
During or at the end of the research, the data collected on the participants and sent to the manager by the 
people who direct and monitor the research (or any other specialised contributor) will be codified. The data 
must never explicitly mention the names of the persons concerned or their addresses. 
The manager will ensure that each research participant has been informed of access to the individual data 
concerning them and strictly necessary for the quality control of the research. 

 
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10. ETHICAL AND REGULATORY CONSIDERATIONS 
The study director who directs and supervises the research commit himself to ensure that this research is 
carried out in accordance with the Declaration of Helsinki (which can be found in full at 
http://www.wma.net/en/30publications/10policies/b3/). 
The data recorded during this research are the subject of a computerised processing in accordance with the 
law no. 78-17 of 6 January 1978 on data processing, files and liberties as amended by Law 2004-801 of 6 
August 2004. This research is part of the "Reference Methodology" (MR-004). The Groupe Hospitalier de la 
Rochelle Ré Aunis has signed a compliance commitment to this "Reference Methodology".  
This research has been registered on the site http://clinicaltrials.gov/  
11. RULES FOR PUBLICATION 
11.1. 
Scientific communications 
The data analysis provided by the centres is carried out by Groupe Hospitalier de la Rochelle Ré Aunis. This 
analysis results in a written report which is submitted to the manager. This report allows the preparation of 
one or more publications. 
Any written or oral communication of the results of the research must have the prior consent of the person 
who directs and supervises the research and, where appropriate, of all committees set up for the research. 
The publication of the main results must mention the name of the manager, all the investigators who helped 
in the inclusion or follow-up of patients in the research, methodologists, biostatisticians and data managers 
who participated in the research, members of the committee(s) constituted for the research. International rules 
of writing and publication will be taken into account (Vancouver Convention, February 2006). 
11.2. 
Communication of results to patients 
At their request, research participants are informed of the overall results of the research. 
11.3. 
Transfer of data 
The collection and management of data is provided by Groupe Hospitalier de la Rochelle Ré Aunis. The 
conditions for the transfer of all or part of the research database are decided by the research manager are the 
subject of a written contract. 

 
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BIBLIOGRAPHIC REFERENCES 
1.  
Kehlet H (1997) Multimodal approach to control postoperative pathophysiology and rehabilitation. 
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2.  
Soffin EM, Yadeau JT (2016) Enhanced recovery after surgery for primary hip and knee 
arthroplasty: A review of the evidence. Br J Anaesth 117:iii62–iii72. 
https://doi.org/10.1093/bja/aew362 
3.  
National Institute for Health and Care Excellence (2020) Perioperative care in adults NG180 
4.  
Culliford D, Maskell J, Judge A, et al (2015) Future projections of total hip and knee arthroplasty in 
the UK: Results from the UK Clinical Practice Research Datalink. Osteoarthr Cartil 23:594–600. 
https://doi.org/10.1016/j.joca.2014.12.022 
5.  
Klug A, Gramlich Y, Rudert M, et al (2020) The projected volume of primary and revision total 
knee arthroplasty will place an immense burden on future heath care systems over the next 30 years. 
Knee Surgery, Sport Traumatol Arthrosc. https://doi.org/10.1007/s00167-020-06154-7 
6.  
Kehlet H (2020) History and future challenges in fast-track hip and knee arthroplasty. Orthopade 
49:290–292. https://doi.org/10.1007/s00132-020-03865-0 
7.  
Wainwright TW, Kehlet H (2019) Fast-track hip and knee arthroplasty–have we reached the goal? 
Acta Orthop 90:3–5. https://doi.org/10.1080/17453674.2018.1550708 
8.  
Li Z, Zhao Q, Bai B, et al (2018) Enhanced Recovery After Surgery Programs for Laparoscopic 
Abdominal Surgery: A Systematic Review and Meta-analysis. World J Surg 42:3463–3473. 
https://doi.org/10.1007/s00268-018-4656-0 
9.  
Wind TC, Barfield WR, Moskal JT (2013) The effect of tranexamic acid on blood loss and 
transfusion rate in primary total knee arthroplasty. J Arthroplasty 28:1080–1083. 
https://doi.org/10.1016/j.arth.2012.11.016 
10.  
Kurz A, Sessler D, Lenhardt R (1996) Perioperative normothermia to reduce the incidence of 
surgical wound infection and shorten hospitalization. J Neurosurg Anesthesiol 8:314–315. 
https://doi.org/10.1097/00008506-199610000-00013 
11.  
Jaeger P, Nielsen Z, Henningsen M, et al (2013) Adductor Canal Block versus Femoral Nerve Block 
and Quadriceps Strength. Anesthesiology 118:409–415. 
https://doi.org/10.1097/ALN.0b013e318279fa0b 
12.  
Lan F, Shen Y, Ma Y, et al (2019) Continuous Adductor Canal Block used for postoperative pain 
relief after medial Unicondylar Knee Arthroplasty: A randomized, double-blind, placebo-controlled 
trial. BMC Anesthesiol 19:1–9. https://doi.org/10.1186/s12871-019-0787-6 
13.  
Sadoghi P, Hasenhütl S, Gruber G, et al (2018) Impact of a new cryotherapy device on early 
rehabilitation after primary total knee  arthroplasty (TKA): a prospective randomised controlled trial. 
Int Orthop 42:1265–1273. https://doi.org/10.1007/s00264-018-3766-5 
14.  
Healy WL, Della Valle CJ, Iorio R, et al (2013) Complications of total knee arthroplasty: 
Standardized list and definitions of the knee society knee. Clin Orthop Relat Res 471:215–220. 
https://doi.org/10.1007/s11999-012-2489-y 
15.  
Jørgensen CC, Kehlet H (2013) Outcomes in smokers and alcohol users after fast-track hip and knee 
arthroplasty. Acta Anaesthesiol Scand 57:631–638. https://doi.org/10.1111/aas.12086