Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

NCT02895607 | Completed DMC

• 1 other identifier: DIDTGENOU
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• Assessment of pain by visual analogue scale VAS

  Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)

  Day 45

Secondary Outcomes (2)

• Assessment of sleep quality

  Day 45

• Assessment of Patient satisfaction

  Day 45

Interventions

Ambulatory care among eligible patients PROCEDURE

The management of Anterior Cruciate Ligament (ACL) Reconstruction 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 in CA (ambulatory surgery) or HC (conventional hospitalization).

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the orthopedic unit for anterior cruciate ligament (ACL)

You may qualify if:

• Isolated ACL tear
• First arthroscopic reconstruction at DIDT

You may not qualify if:

• Age over 60 years
• ASA score greater than 2
• Geographical remoteness
• Social isolation
• medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
• psychiatric pathology

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Pierre Emmanuel MOREAU, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 9, 2016
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 10, 2018

Record last verified: 2016-09

Locations

FR (1)