- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737719
Utilization of Rehabilitation Prior to Surgery Among Patients With Anterior-cruciate Ligament Knee Injury (prehab-ACL)
April 19, 2024 updated by: Nantes University Hospital
Utilization of Rehabilitation Prior to Surgery Among Patients With Anterior-cruciate Ligament Knee Injury: a Retrospective Review of the French National Health Database (Prehab-ACL)
This research aims to assess physiotherapy utilization in the treatment of patients with an anterior-cruciate ligament knee injury, when delivered before their surgery (prehab), and its potential effects on absence from work, and patients global health consumptions (before and after the surgery).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Based on the codes generated from French National health database, patients with prehab (+post-surgery rehabilitation) will be compared to patients receiving only post-surgery rehabilitation
Study Type
Observational
Enrollment (Estimated)
864000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillaume LE SANT, Assistant professor | PhD, PT
- Phone Number: 33 251795192
- Email: guillaume.le-sant@univ-nantes.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Preparing the patient for a surgical procedure had been well known in physiotherapy.
Presurgical exercise aiming to improve functional capacity before a surgical procedure leads to more rapid postoperative recovery compared with patients who remain physically inactive through the preoperative period
Description
Inclusion Criteria:
- First episod of ACL-surgery
Exclusion Criteria:
- No history or previous ACL-surgery
- No rehabilitation after surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prehab
Patients awaiting a knee surgical procedure, and after the surgery
|
Physiotherapy strategies for preparing the patient awaiting the surgical procedure
Physiotherapy strategies to manage post-surgery recovery
|
|
Control
Patients after the surgery
|
Physiotherapy strategies to manage post-surgery recovery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consumption of physiotherapy services
Time Frame: - 3 months up to surgery
|
Total number of sessions, frequency (/week)
|
- 3 months up to surgery
|
|
Consumption of physiotherapy services
Time Frame: from surgery up to 18 months later
|
Total number of sessions, frequency (/week)
|
from surgery up to 18 months later
|
|
Absence from work
Time Frame: - 3 months up to surgery
|
Number of days
|
- 3 months up to surgery
|
|
Absence from work
Time Frame: from surgery up to 18 months later
|
Number of days
|
from surgery up to 18 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health consumption 1
Time Frame: - 3 months up to surgery
|
Appointments to MD, nurses (total number)
|
- 3 months up to surgery
|
|
Health consumption 1
Time Frame: from surgery up to 18 months later
|
Appointments to MD, nurses (total number)
|
from surgery up to 18 months later
|
|
Health consumption 2
Time Frame: - 3 months up to surgery
|
Drugs and medical imaging (total number)
|
- 3 months up to surgery
|
|
Health consumption 2
Time Frame: from surgery up to 18 months later
|
Drugs and medical imaging (total number)
|
from surgery up to 18 months later
|
|
Health consumption 3
Time Frame: from surgery up to 18 months later
|
Hospital stay (number, length)
|
from surgery up to 18 months later
|
|
Health consumption 4
Time Frame: from surgery up to 18 months later
|
Re-injury (surgery, number)
|
from surgery up to 18 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
February 10, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC22_0485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior-cruciate Ligament Knee Injury
-
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