Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00620477
First received: February 8, 2008
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint.
Drug: injection in the knee joint with 20 ml of chirocaine 0.125%
Drug: injection in the knee joint with 20 ml of physiological fluid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: within 4 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Question Form, Visual Analogue Scale [ Time Frame: one day after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
injection in the knee joint with 20 ml of chirocaine 0.125%
Drug: injection in the knee joint with 20 ml of chirocaine 0.125%
injection in the knee joint with 20 ml of chirocaine 0.125%
Placebo Comparator: 2
injection in the knee joint with 20 ml of physiological fluid
Drug: injection in the knee joint with 20 ml of physiological fluid
injection in the knee joint with 20 ml of physiological fluid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620477

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Luc Herregods, MD, PhD    +32 9 332 44 95    luc.herregods@ugent.be   
Contact: Fredrik Almqvist, MD, PhD    +32 9 332 22 24    Fredrik.almqvist@ugent.be   
Principal Investigator: Luc Herregods, MD, PhD         
Principal Investigator: Fredrik Almqvist, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Luc Herregods, MD, PhD University Hospital, Ghent
Principal Investigator: Fredrik Almqvist, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00620477     History of Changes
Other Study ID Numbers: 2008/068
Study First Received: February 8, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Rupture
Wounds and Injuries
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014