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Fast-track Rehabilitation After Total Knee or Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03035435
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Chiara Arienti, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:
In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.

Condition or disease Intervention/treatment
Knee Arthroplasty Hip Arthroplasty Other: fast-track rehabilitation Other: standard care rehabilitation

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
study group
fast-track rehabilitation
Other: fast-track rehabilitation
control group
standard care rehabilitation
Other: standard care rehabilitation



Primary Outcome Measures :
  1. International Knee Society Score [ Time Frame: Change from Baseline fast-track rehabilitation at 8th and 15th day ]
  2. Merle D'Aubigne' scale [ Time Frame: Change from Baseline fast-track rehabilitation at 8th and 15th day ]

Secondary Outcome Measures :
  1. Barthel Index [ Time Frame: Change from Baseline fast-track rehabilitation at 8th and 15th day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The recruitment will take place to Rehabilitation Unit of Don Gnocchi Foundation of Rovato (Brescia, Italy), from January 2016 to August 2016. An informed consent will be signed by each participant in agreement with Helsinki Declaration. The study is approved by the local Ethical Committee.
Criteria

Inclusion Criteria:

  • adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).

Exclusion Criteria:

  • the presence of pain measured with NRS (NRS>4)
  • rheumatoid arthritis, past surgery
  • cancer
  • neurological and psychiatric disorders
  • dementia with Minimental Test<24
  • pregnancy
  • participation in the other clinical studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035435


Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
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Principal Investigator: Chiara Arienti, PhD(s) IRCCS Don Gnocchi Foundation

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Responsible Party: Chiara Arienti, PhD, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT03035435     History of Changes
Other Study ID Numbers: Fast Track Rehab
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Chiara Arienti, Fondazione Don Carlo Gnocchi Onlus:
fast-track rehabilitation
fast-track surgery