Arthroplasty ComplicationsNCT05028426
Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
An observational study of Arthroplasty Complications, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Enhanced recovery program
- Type of treatment
- Surgery or procedure
- How many people
- 455 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- revision arthroplasty
- patients who refused to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
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.
Read the 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.
- Conditions
- Arthroplasty Complications
- Being tested
- Enhanced recovery program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery programProcedure or surgery
Enhanced recovery programs are a multimodal approach to optimize patients' physiological and psychological states in the preoperative, intraoperative and postoperative care domains.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Enhanced recovery 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) Receives: Procedure: Enhanced recovery program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (6)
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.
Measured: up to 28 months after surgery
Length of Hospital Stay
the time between admission for an operation and discharge from the hospital
Measured: up to 1 month after surgery
Preoperative Knee Extension
Measure in degree of how much the knee straightens during consultation with surgeon
Measured: up to 1 month before surgery
Postoperative Knee Extension
Measure in degree of how much the knee straightens during consultation with surgeon
Measured: At 3 months after surgery
Preoperative Knee Flexion
Measure in degree of how much the knee bends during consultation with surgeon
Measured: up to 1 month before surgery
Postoperative Knee Flexion
Measure in degree of how much the knee bends during consultation with surgeon
Measured: At 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study startJan 2015
- Primary completionDec 2018
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivien Fontaine, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028426
- Sponsor's protocol ID
- 2018/P01/266
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2021
- Last updated
- 7 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program
- ClinicalTrials.gov ID
- NCT05028426
- Acronym / sponsor ID
- 2018/P01/266
- Conditions
- Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 7 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional method of care | – | –Patients managed according to the traditional care protocol without an enhanced recovery program |
| Some elements of a fast-track program | – | Procedure: Enhanced recovery programoperative and postoperative techniques were modified according to a fast-track program |
| Full enhanced recovery program | – | Procedure: Enhanced recovery programPatients were managed in an enhanced recovery program (elements of the previous fast-track program were modified and preoperative education was added) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- revision arthroplasty
- patients who refused to the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery programEnhanced recovery programs are a multimodal approach to optimize patients' physiological and psychological states in the preoperative, intraoperative and postoperative care domains. | Procedure or surgery | Full enhanced recovery program, Some elements of a fast-track program |
Primary outcome
Number of Patients With Early Complication
Time frame: 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.
6 secondary outcomes
Number of Patients With Late Complication
Time frame: up to 28 months after surgery
Length of Hospital Stay
Time frame: up to 1 month after surgery
Preoperative Knee Extension
Time frame: up to 1 month before surgery
Postoperative Knee Extension
Time frame: At 3 months after surgery
Preoperative Knee Flexion
Time frame: up to 1 month before surgery
Postoperative Knee Flexion
Time frame: At 3 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivien Fontaine, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Early Complication (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.