Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial
Primary Purpose
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
injection in the knee joint with 20 ml of chirocaine 0.125%
injection in the knee joint with 20 ml of physiological fluid
Sponsored by
About this trial
This is an interventional treatment trial for Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
Eligibility Criteria
Inclusion Criteria:
- Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study.
- Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted.
Exclusion Criteria:
- Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study.
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
injection in the knee joint with 20 ml of chirocaine 0.125%
injection in the knee joint with 20 ml of physiological fluid
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Secondary Outcome Measures
Question Form, Visual Analogue Scale
Full Information
NCT ID
NCT00620477
First Posted
February 8, 2008
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00620477
Brief Title
Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial
Official Title
Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2008 (Actual)
Primary Completion Date
November 3, 2010 (Actual)
Study Completion Date
November 3, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of the knee joint, will be treated with an operative ACL-reconstruction. One group of patients will stay one night in the hospital and go home the other day (Group I). The other group of patients will go home the same day of surgery (Group II). All patients will undergo the same arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a classic manner. At the end of the surgery each group of patients will be randomly divided in two subgroups: one group will get an injection in the knee joint with 20 ml of physiological fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 ml of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a double blind, randomized way. The whole procedure takes about one hour. After surgery patients are brought to the recovery room and are observed every 30 minutes for the duration of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual Analogue Scale, to determine their pain. After being brought to their rooms, the patients will have the choice of going home the same day or staying in the hospital for one night, according to the amount of pain they are in. That moment it will be possible to switch groups. Patients who go home the same day of surgery will be contacted by phone the day after to fill in a question form. Patients who were admitted for one night will be seen before their leave to fill in the same question form.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
injection in the knee joint with 20 ml of chirocaine 0.125%
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
injection in the knee joint with 20 ml of physiological fluid
Intervention Type
Drug
Intervention Name(s)
injection in the knee joint with 20 ml of chirocaine 0.125%
Intervention Description
injection in the knee joint with 20 ml of chirocaine 0.125%
Intervention Type
Drug
Intervention Name(s)
injection in the knee joint with 20 ml of physiological fluid
Intervention Description
injection in the knee joint with 20 ml of physiological fluid
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
within 4 hours after surgery
Secondary Outcome Measure Information:
Title
Question Form, Visual Analogue Scale
Time Frame
one day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study.
Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted.
Exclusion Criteria:
Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Herregods, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fredrik Almqvist, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial
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