Anterior Cruciate Ligament Clinical Trial
Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
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.
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. ;
|Source||Groupe Hospitalier Paris Saint Joseph|
|Start date||December 2014|
|Completion date||May 2015|
|Active, not recruiting||
|Active, not recruiting||
||Early Phase 1|