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Clinical Trial Summary

Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.


Clinical Trial Description

II. objectives

at. primary objective

Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.

Evaluation criteria (absence of EG)?

b. secondary objectives

i. Evaluation of the acceptance rates of ambulatory care patients eligible

ii. Evaluation of the rate and type of complication in our series

iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)

IV. Methodology and duration of the research

This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.

The inclusion of patients will take place over a period of 4 months.

The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.

After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.

Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.

Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.

The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02895607
Study type Observational
Source Groupe Hospitalier Paris Saint Joseph
Contact
Status Completed
Phase
Start date December 2014
Completion date May 2015

See also
  Status Clinical Trial Phase
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Completed NCT00492609 - Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL) N/A
Recruiting NCT01148784 - Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction N/A
Completed NCT01194505 - Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL) N/A
Active, not recruiting NCT00490594 - SeriACLâ„¢ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction Phase 1
Recruiting NCT01919658 - Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair N/A
Terminated NCT00717171 - Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair Phase 4
Active, not recruiting NCT03429140 - Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions Early Phase 1